NMPA GMP Announcement 107: Dual Release, Key-Person Gates, and the 1 November 2026 Clock

China NMPA GMP Announcement 107 operating guide: Order 53 manufacturing licenses vs 107 GMP, dual release, full-time key-person gates, and 1 November 2026.

For regulatory affairs directors, quality assurance vice presidents, legal representatives, and operations executives managing medical device manufacturing in China or utilizing Chinese contract manufacturing organizations (CMOs), China's quality system regime is facing its most significant overhaul in more than a decade.

On 4 November 2025, the National Medical Products Administration (NMPA) issued Announcement No. 107 of 2025 (document index FGWJ-2025-10085), releasing the revised Good Manufacturing Practice for Medical Devices (医疗器械生产质量管理规范). The Chinese announcement (index FGWJ-2025-10085) is dated 4 November 2025. Official English announcement and news pages were updated on 7 November 2025. The revised text is the operating GMP baseline from 1 November 2026.

Search results and industry summaries have created widespread operational confusion:

The Legal Transition Trap: Official English announcements state that Announcement 107 comes into force on 1 November 2026 and that the previous baseline, CFDA Announcement No. 64 of 2014, is repealed on the same date. Neither the announcement nor Article 132 of the annex provides any subsequent grace period. Yet some manufacturers mistakenly assume 107 has already repealed the 2014 text today, while others assume a multi-year transition will follow 1 November 2026.
The Two-Instrument Confusion: Consultancies often conflate the manufacturing license with the GMP text. An Announcement 107 revision is not a new manufacturing license; State Administration for Market Regulation (SAMR) Decree No. 53 (promulgated 10 March 2022, effective 1 May 2022) remains the statutory licensing regulation for domestic plants.
The Dual-Release Origin Error: Commentators frequently claim Announcement 107 invented dual release. In reality, Order 53 Article 34 established the statutory requirement for marketing release by the registrant and production release by the contract manufacturer back in 2022. Announcement 107 Articles 104 and 113 operationalize this split and establish an absolute prohibition: listing release must be performed by the registrant itself and cannot be delegated to another enterprise.
The Personnel Qualification Shock: Companies relying on generic ISO 13485 "competence evaluation" records are discovering that Announcement 107 establishes rigid, statutory personnel qualification gates. Production heads and quality heads must not hold each other's posts concurrently (Article 14), and key positions must be full-time employees (Article 17) possessing specific medical device educational degrees and verified three-year experience baselines (Articles 19–21).
The Article Count Discrepancy: Early English commentary, including an earlier stub in our China NMPA registration overview, cited 15 chapters and 131 articles. The official NMPA annex contains 15 chapters and 132 articles.

Direct Answer. NMPA Announcement No. 107 of 2025, issued 4 November 2025, publishes the revised Chinese Good Manufacturing Practice for Medical Devices. Both the official announcement and Article 132 of the annex establish that the revised GMP takes effect on 1 November 2026, simultaneously repealing CFDA Announcement No. 64 of 2014. Neither the announcement nor Article 132 grants any further grace period after 1 November 2026. Official NMPA notices confirm the text consists of 15 chapters and 132 articles, adding three dedicated chapters: Quality Assurance (Chapter 2, Articles 7–13), Validation and Verification (Chapter 9, Articles 69–77), and Contract Manufacture and Outsourced Processing (Chapter 12, Articles 107–116).

Announcement 107 revises the substantive GMP quality management system (QMS) standard; it is not a new manufacturing license. Domestic Chinese manufacturing facilities must still obtain and maintain a Medical Device Manufacturing License under SAMR Decree No. 53 (Order 53): Class II and Class III facilities require a provincial license valid for 5 years (Order 53 Articles 4 and 14), inspected against NMPA GMP (Article 13), while Class I facilities require a municipal filing.

Dual release is not new in 107. Order 53 Article 34 codified dual release in 2022. Announcement 107 Article 104 reinforces that for contract manufacturing, release comprises production release (生产放行) by the contract manufacturer and listing release (上市放行) by the registrant or filing entity (Marketing Authorization Holder / MAH). Crucially, Article 113 mandates that listing release must be completed by the entrusting registrant itself and cannot be delegated to another enterprise.

On personnel, Article 14 strictly bans production management heads and quality management heads from concurrently holding each other's positions. Article 15 equips the quality department with independent product quality veto power. Article 17 designates the principal responsible person, management representative, production head, quality head, and release reviewer as mandatory full-time personnel. For Class II and Class III devices, Articles 19 and 20 require the management representative and quality head to hold a bachelor's degree or higher in a device-related specialty (or an intermediate technical title) plus generally at least three years of relevant experience.

ISO 13485 certification, MDSAP audit certificates, and US FDA QMSR compliance do not waive Chinese GMP or Order 53 licensing requirements. While Order 53 Article 2 restricts manufacturing license requirements to facilities operating inside the PRC, GMP Article 2 applies to registrants, filing entities, and contract manufacturers without an offshore exemption. Overseas manufacturers of imported devices are held to China GMP through their registration dossiers, overseas flight inspections, and the mandatory annual QMS self-inspection report submitted through their China agent to the provincial regulator by 31 March each year under Order 53 Article 45.

Finally, do not confuse public UDI registrations with manufacturing sites. In the official NMPA UDI public extract (snapshot as of 2 September 2026), there are 6,139,557 normalized device and IVD identifier records (5,900,360 medical devices and 239,640 IVDs). These records index registered packaging units and product codes; they contain no data fields for GMP compliance, facility licenses, or plant audits, and cannot be cited as a census of GMP-compliant manufacturing plants.

Quick Reference: The Chinese Medical Device Quality Regime

Dimension	NMPA GMP Announcement 107 (2025)	SAMR Decree No. 53 (Order 53, 2022)	International Baseline (ISO 13485 / MDSAP)
Legal Nature	Technical GMP Standard / Administrative Normative Document	Administrative Regulation / Departmental Rule	Voluntary Consensus Standard / Multi-Country Audit Scheme
Authority	National Medical Products Administration (NMPA)	State Administration for Market Regulation (SAMR) / NMPA	ISO / International IMDRF Auditing Organizations
Effective Date	1 November 2026 (Issued 4 Nov 2025; repeals 2014 No. 64)	1 May 2022 (Promulgated 10 March 2022)	Current edition ISO 13485:2016; QMSR effective 2 Feb 2026
Document Structure	15 Chapters, 132 Articles (adds Chapters 2, 9, 12)	6 Chapters, 76 Articles	8 Clauses (ISO 13485:2016)
Licensing Role	Audit standard for facility compliance and inspections	Statutory instrument that issues the 5-year Manufacturing License	None (Certification audits do not issue Chinese state licenses)
Jurisdictional Reach	Applies to registrants, filing entities, and CMOs (Art. 2)	Territorial: applies to manufacturing activities inside the PRC	Global
Dual Release	Arts. 104 & 113: MAH performs listing release; CMO performs production release; listing release cannot be delegated to another enterprise	Art. 34: Registrant/filing entity is responsible for marketing release; CMO establishes manufacturing-release procedures	Clause 8.2.6 (product monitoring/release) plus Clause 4.1.5 for outsourced processes
Personnel Gates	Arts. 14, 17, 19–22: Mandatory full-time key posts; degree & 3-yr bars; concurrent-post ban	Arts. 9, 26–28: Plant conditions, legal representative/principal responsibility, management representative, training	Clause 6.2: Competence based on self-determined education and training
Statutory Fees	0 RMB (No NMPA government fee for the text itself)	Provincial fee schedules for manufacturing license applications	Commercial registrar and auditing organization fees

Is Announcement 107 Already the Operating GMP, or Does 2014 No. 64 Still Govern Until 1 November 2026?

The regulatory timeline between November 2025 and November 2026 presents a dual-state compliance challenge.

When NMPA issued Announcement No. 107 on 4 November 2025, it established a fixed implementation window through 1 November 2026:

Date	Legal status	What operators should treat as binding
4 November 2025	Announcement No. 107 issued (15 chapters, 132 articles)	CFDA Announcement No. 64 of 2014 remains the GMP text in force.
4 November 2025 – 31 October 2026	Transition / remediation window	2014 No. 64 still governs inspections; 107 is published but not yet the sole operating text.
1 November 2026	Cutover	Article 132 and the announcement repeal 2014 No. 64 the same day. Announcement 107 becomes the operating GMP. Neither text adds a further grace period.

The Transition Dual State

Legally, CFDA Announcement No. 64 of 2014 remains the official GMP standard in force until 31 October 2026. On 1 November 2026, CFDA Announcement No. 64 is repealed simultaneously with Announcement 107 taking effect.

However, treating Announcement 107 as a distant concern is an operational mistake:

Provincial MPA audits: The announcement does not freeze 2026 surveillance practice. Provincial bureaus may already ask 107-readiness questions during 2026 inspections even though Article 132 names 1 November 2026 as the switch date. That is an inspection-practice risk, not a second official effective date.
No Extra Grace Period: Neither Announcement 107 nor Article 132 contains a phased grace period for existing certificate holders. Unlike European MDR/IVDR extensions or US FDA QMSR transition schedules, the Chinese text takes effect as a complete, binding cutover on 1 November 2026.
Flight Inspection Preparedness: As detailed in our China NMPA Flight Inspection (Order 14) Playbook, unannounced inspection teams inspect against the legally active standard on the day of the audit. Audits occurring on or after 1 November 2026 will cite non-conformances directly against the 132 articles of Announcement 107.

The Authentic 15-Chapter, 132-Article Structure

A frequent error in English regulatory analyses is quoting 131 articles. The official NMPA annex, retrieved from the Chinese announcement page, contains 15 chapter headings and 132 article headings. Official English and Chinese news pages state the same 15/132 count.

The revised structure introduces three completely new chapters and reconfigures critical operational controls:

Chapter	Chinese Title	English Translation	Article Span	Key Operational Content & Additions
Chapter 1	总则	General Provisions	Arts. 1–6	Scope, risk-based management, QMS lifecycle coverage.
Chapter 2	质量保证	Quality Assurance	Arts. 7–13	NEW CHAPTER. Independent QA system, quality manual, change control, deviation management.
Chapter 3	机构与人员	Organization and Personnel	Arts. 14–24	Concurrent-post bans (Art. 14), quality veto (Art. 15), full-time key posts (Art. 17), degree/experience gates (Arts. 19–22).
Chapter 4	厂房与设施	Premises and Facilities	Arts. 25–35	Cleanroom classifications, environmental monitoring, pest and contamination controls.
Chapter 5	设备	Equipment	Arts. 36–41	Installation, maintenance, calibration, automated equipment qualification.
Chapter 6	文件和数据管理	Documents and Data Management	Arts. 42–46	Electronic records (Art. 46). Record retention: at least the enterprise-defined device lifetime or the period required by relevant rules, and not less than 2 years from release (Art. 45).
Chapter 7	设计开发	Design and Development	Arts. 47–58	Design planning, inputs/outputs, design transfer, design changes, risk management.
Chapter 8	采购与原材料管理	Purchasing and Raw-Materials Management	Arts. 59–68	Supplier qualification, procurement agreements, incoming inspection, traceability.
Chapter 9	确认与验证	Validation and Verification	Arts. 69–77	NEW CHAPTER. V&V master plan, revalidation triggers, computerized system validation (CSV) and software confirmation (Art. 77).
Chapter 10	生产管理	Production Management	Arts. 78–94	Batch records, contamination control, UDI marking/upload (Art. 91), nonconforming product handling (Arts. 88–89).
Chapter 11	质量控制与产品放行	Quality Control & Product Release	Arts. 95–106	QC testing, finished goods release, dual-release framework (Art. 104), routine test outsourcing restrictions (Art. 106).
Chapter 12	委托生产与外包加工	Contract Manufacture & Outsourced Processing	Arts. 107–116	NEW CHAPTER. Contract manufacturing agreements (Art. 108), on-site audits (Art. 109), listing release non-delegation (Art. 113).
Chapter 13	销售与售后服务	Sales and After-Sales Service	Arts. 117–120	Distribution traceability, customer service, customer feedback.
Chapter 14	分析和改进	Analysis and Improvement	Arts. 121–129	CAPA, internal audits, management review, adverse event monitoring, product recalls.
Chapter 15	附则	Supplementary Provisions	Arts. 130–132	Article 130 documented inapplicability justification; Article 132 effective date (1 Nov 2026) and repeal of 2014 No. 64.

Notice that Nonconforming Product Control is not a standalone chapter; it is embedded directly within Chapter 10 (Articles 88 and 89). Furthermore, Chapter 9 (Validation and Verification) spans Articles 69 through 77, addressing equipment qualification, process validation, cleaning validation, and computerized systems.

Is 107 a New Manufacturing License, or Does Order 53 Still Issue the License While 107 Revises the GMP Text?

A critical source of regulatory failure is misunderstanding the difference between an administrative regulation and a technical quality standard.

China's medical device governance operates on a clear two-instrument architecture:

Instrument	Legal nature	What it issues or requires	What it does not do
SAMR Decree No. 53 (Order 53, 2022)	Administrative regulation	Territorial manufacturing license/filing inside the PRC (Arts. 2, 4); 5-year license (Art. 14); GMP inspection of license applications within 20 working days (Art. 13)	Does not itself rewrite the 132-article GMP text
NMPA Announcement No. 107 of 2025	GMP technical standard	The QMS text inspectors audit (15 chapters, 132 articles), including dual-release operations (Arts. 104, 113) and key-person gates (Arts. 14, 17–22)	Does not issue a separate "GMP license" or replace Order 53

The Role of SAMR Decree No. 53 (Order 53)

Promulgated by the State Administration for Market Regulation on 10 March 2022 and effective since 1 May 2022, Order 53 governs the licensing and supervision of medical device manufacturing:

Territorial Scope (Article 2): Order 53 applies explicitly to production and manufacturing activities conducted within the territory of the People's Republic of China.
License Classification (Article 4): Manufacturing Class II and Class III medical devices requires a Medical Device Manufacturing License (医疗器械生产许可证) issued by the provincial MPA. Manufacturing Class I devices requires a Class I Medical Device Production Filing (第一类医疗器械生产备案) with the municipal-level MPA.
Statutory Validity (Article 14): A Medical Device Manufacturing License is valid for 5 years. Order 53 Article 17 requires renewal applications within 30 to 90 working days before expiration; applications filed after that window are no longer accepted.
On-Site Inspection Protocol (Article 13): When reviewing a manufacturing license application, the provincial MPA must conduct a technical verification, including an on-site inspection against NMPA GMP, within 20 working days. The regulation explicitly directs authorities to combine license verification with registration-system inspections to prevent duplicative administrative burdens.
QMS Maintenance (Article 25): Registrants, filing entities, and contract manufacturers must establish and maintain an effective quality management system in strict accordance with the medical device GMP.

The Role of Announcement No. 107 of 2025

Announcement 107 does not replace Order 53, nor does it create a new category of manufacturing license. Instead, Announcement 107 updates the substantive technical benchmark that Order 53 enforces.

When a domestic manufacturer applies for a new manufacturing license, undergoes a 5-year license renewal, or receives a routine surveillance inspection on or after 1 November 2026, the provincial MPA inspectors will walk through the facility using the 132 articles of Announcement 107 as their evaluation checklist. For cross-market context, see our four-jurisdiction QMS legal-text comparison, which examines how China's two-instrument structure compares to US FDA QMSR, Brazilian ANVISA RDC 665/2022, and Mexican COFEPRIS standards.

Who Signs Production Release Versus Listing Release, and Can the MAH Delegate Listing Release to the CMO?

The operationally demanding 107 addition is not inventing dual release. It is specifying how inspectors will audit it, including Article 113's rule that listing release cannot be delegated to another enterprise.

The Origin: Order 53 Article 34

Industry participants often assume dual release is an invention of Announcement 107. In fact, Order 53 Article 34 established the statutory requirement four years earlier:

The official English text of Order 53 Article 34 is broader than a CMO-only rule. Marketing release is a registrant/filing-entity duty for products generally; contract manufacture adds a second manufacturing-release file that the registrant must also review:

"The registrant or filing entity of medical devices shall be responsible for marketing release of the products, establishing procedures for marketing release of products, specifying the release criteria and conditions, and reviewing the manufacturing process records and quality testing reports of the medical devices, and if conforming to criteria and conditions, the medical products can enter the market only upon signature of the authorized release personnel. For entrusted manufacturing, the registrant or filing entity of medical devices shall also review the manufacturing release document from the contract manufacturer."

"The contract manufacturer shall establish procedures for manufacturing release, specify the criteria and conditions for manufacturing release, and ensure that only those conforming to the criteria and conditions could be released from the factory."

Announcement 107 does not invent dual release; it operationalizes it, providing the granular quality criteria that inspectors will audit.

The Dual-Release Mechanics: Articles 104 and 113

Announcement 107 Chapter 11 (Quality Control and Product Release) and Chapter 12 (Contract Manufacture and Outsourced Processing) establish the operational boundaries:

Stage	Chinese term	Who signs	What it authorizes	What it does not authorize
1. Production release	生产放行	Entrusted manufacturer (CMO) quality function / authorized release personnel (Arts. 17, 22, 104, 113)	Factory release after batch records, in-process and finished testing, and production-release criteria are met	Commercial distribution into the China market
2. Listing / marketing release	上市放行	Registrant or filing entity (MAH), using its own authorized release personnel (Arts. 104, 113)	Market entry after review of production records, QC records, and the CMO's production-release file against PTR, labeling, and UDI	Delegation of that signature to another enterprise

The Absolute Non-Delegation Rule (Article 113)

Under international QMS frameworks such as ISO 13485:2016 (Clause 4.1.5 for outsourced processes and Clause 8.2.6 for monitoring and measurement of product), a manufacturer can outsource processes—including some verification activities—provided adequate quality agreements and oversight controls are documented. That ISO outsourcing permission does not authorize delegating China listing release.

Announcement 107 Article 113 states, in the official Chinese annex:

"委托方应当建立产品上市放行规程，明确放行标准、条件，对医疗器械生产过程记录、质量控制记录和受托方生产放行文件进行审核，符合标准和条件的，经授权的放行人员签字后方可上市。产品上市放行由委托方自行完成，不得委托其他企业进行。"

"受托方应当建立生产放行规程，明确生产放行标准、条件，对医疗器械生产过程记录和质量控制记录进行审核，符合标准、条件的，经授权的放行人员签字后方可出厂。"

(The entrusting party shall establish listing-release procedures, review manufacturing-process records, quality-control records, and the entrusted party's production-release file, and may place the product on the market only after authorized release personnel sign. Listing release shall be completed by the entrusting party itself and shall not be delegated to another enterprise. The entrusted party establishes production-release procedures and may ship from the factory only after its authorized release personnel sign.)

If a foreign or domestic registrant inserts a quality-agreement clause stating that the CMO shall perform final market release on behalf of the registrant, that clause conflicts with Article 113. The registrant must maintain its own qualified, trained, and authorized Release Reviewer (放行审核人) who reviews the CMO's production-release records and executes a separate listing-release record before products are placed on the market.

Supporting Contract Manufacturing Safeguards

Announcement 107 reinforces dual release with three additional binding requirements:

Non-Transfer of Legal Duties (Article 108): The entrustment quality agreement cannot transfer statutory legal responsibilities from the registrant to the contract manufacturer. The registrant remains strictly liable for device safety, quality, adverse event reporting, and post-market surveillance.
Mandatory On-Site Assessments and Audits (Article 109): Before contract manufacture, the registrant must conduct an on-site capability assessment of the CMO. During the contract, it must conduct periodic on-site QMS audits. Paper-only desktop audits do not satisfy Article 109. Article 110 separately requires the entrusting party to staff a quality organization with enough full-time quality personnel to monitor the entrusted activity.
Restrictions on Outsourcing Routine Testing (Article 106): Article 106 states that incoming, in-process, and finished-product inspection items that require routine control generally must not be contracted out (一般不得进行委托检验). Items with high inspection-condition or equipment requirements that genuinely need outsourcing may be contracted to a qualified institution, with a quality agreement, capability evaluation, and confirmation of results. That is not a ban on every specialized assay (for example, some sterilization-residual or biocompatibility tests), and it is not a requirement to end all external testing.

Step-by-Step Dual-Release Execution Matrix

Step	Process Stage	Performing Entity	Regulatory Basis	Required Documentation & Records	Audit Failure Risk
1	Production Execution	Contract Manufacturer (CMO)	Chapter 10 (Arts. 78–87)	Completed Batch Production Records (BPR), cleanroom monitoring logs, machine logs.	Missing equipment maintenance logs; uncalibrated sensors.
2	In-Process & Finished QC	Contract Manufacturer (CMO)	Chapter 11 (Arts. 95–103, 106)	Inspection test sheets, sterilization verification records, Certificate of Analysis (CoA).	Outsourcing routine QC testing without Article 106 justification.
3	Production Release	Contract Manufacturer (CMO)	Article 104	Formal Factory Release Approval signed by the CMO's full-time Release Reviewer.	Releasing goods to warehouse without authorized CMO reviewer signature.
4	Dossier Transmission	CMO to Registrant (MAH)	Article 107, 108	Electronic or physical transfer of complete batch manufacturing and testing records.	Incomplete batch records; missing deviation or OOS investigation reports.
5	MAH Verification Review	Registrant / MAH	Chapter 2 (Arts. 7–13), Chapter 11	Audit checklist comparing batch data against approved Product Technical Requirements (PTR).	Approving release despite unresolved production deviations or out-of-spec results.
6	UDI Verification	Registrant / MAH	Article 91	UDI DI/PI verification report; confirmation of upload to NMPA UDI Database.	Shipping product without UDI carrier or before DI data elements are registered.
7	Listing Release	Registrant / MAH	Articles 104, 113	Written Listing Release Certificate executed by the Registrant's in-house Release Reviewer.	CRITICAL FAILURE: Delegating listing release signature to the CMO.
8	Commercial Distribution	Distributor / 3PL	Chapter 13 (Arts. 117–120)	Sales shipping records, customer delivery confirmation, temperature tracking logs.	Shipping goods prior to timestamped MAH Listing Release sign-off.

Which Key Posts Must Be Full-Time, Cannot Be Dual-Hatted, and Need Bachelor-Plus-Three-Years Instead of ISO Competence Alone?

Under ISO 13485:2016 Clause 6.2, personnel competence is governed by a flexible standard: the organization defines the necessary competence, provides training, and maintains appropriate records of education, training, skills, and experience.

Announcement 107 Chapter 3 (Organization and Personnel) takes a more prescriptive approach than ISO competence records.

Role	Chinese term	Full-time?	Concurrent-post rule	Independence
Enterprise principal responsible person	企业负责人	Yes (Art. 17)	—	Overall quality and compliance responsibility (Art. 18)
Production management head	生产管理负责人	Yes (Art. 17)	Cannot also be quality head (Art. 14)	Leads manufacturing operations
Quality management head	质量管理负责人	Yes (Art. 17)	Cannot also be production head (Art. 14)	Independent QA/QC; product-quality veto (Art. 15)
Release reviewer	产品放行审核人	Yes (Arts. 17, 22)	Sits in quality or higher quality management	Independent release authority after training and authorization

The Absolute Concurrent-Post Ban (Article 14)

Article 14 establishes a rigid structural separation of powers:

"生产管理部门和质量管理部门负责人不得互相兼任。" (The heads of the production management department and the quality management department shall not concurrently hold each other's posts.)

In smaller medical device companies, startups, or contract facilities, a single technical director often oversees both plant manufacturing and quality assurance. Under Announcement 107, this arrangement is an explicit statutory violation. The production head (driven by output, efficiency, and schedule) must be organizationally independent of the quality head (driven by compliance and safety).

The Product Quality Veto (Article 15)

To ensure the quality department cannot be overruled by commercial or operational pressures, Article 15 provides statutory backing to quality independence:

The quality management department shall independently perform its quality assurance and quality control responsibilities, and shall possess product quality veto power (对产品质量有否决权).

If the quality department determines that a production lot exhibits unresolved deviations, out-of-specification results, or unvalidated process changes, neither the production head nor the enterprise general manager can legally force product release.

Mandatory Full-Time Key Personnel (Article 17)

Article 17 lists six statutory key positions:

Legal Representative (法定代表人)
Enterprise Principal Responsible Person (企业负责人)
Management Representative (管理者代表)
Production Management Department Head (生产管理部门负责人)
Quality Management Department Head (质量管理部门负责人)
Release Reviewer (放行审核人)

Crucially, Article 17 mandates that positions (2) through (6)—the enterprise principal responsible person, management representative, production head, quality head, and release reviewer—must be full-time personnel (专职人员).

Employing part-time regulatory consultants, fractional quality managers, or shared group-level executives who do not hold dedicated full-time employment contracts with the licensed Chinese manufacturing entity violates Article 17.

Prescriptive Educational and Experience Gates (Articles 19–22)

Announcement 107 establishes non-negotiable credential baselines for Class II and Class III device manufacturers:

Key Role	Regulatory Article	Minimum Educational Degree / Professional Title	Minimum Relevant Experience Baseline	Operational Independence & Governance Rules
Management Representative (管理者代表)	Article 19	Bachelor's degree or higher in a medical device-related specialty (engineering, biology, medicine, chemistry, pharmacy, materials, etc.) OR an intermediate or higher technical professional title (中级以上技术职称).	Generally (原则上) at least 3 years of experience in medical device quality management or manufacturing.	Appointed in writing by enterprise responsible person; reports directly on QMS operation; directly interfaces with NMPA inspectors.
Quality Head (质量负责人)	Article 20	Bachelor's degree or higher in a medical device-related specialty OR an intermediate or higher technical professional title.	At least 3 years of direct experience in medical device production or quality management.	Must not concurrently hold production head post (Art. 14); holds product quality veto power (Art. 15); must be full-time (Art. 17).
Production Head (生产负责人)	Article 21	College diploma (associate degree) or higher (大学专科及以上学历) in a medical device-related specialty. Article 21 does not offer a junior technical-title alternative.	At least 3 years of medical device production or quality-management experience.	Must not concurrently hold quality head post (Art. 14); responsible for process execution, records, and equipment upkeep.
Release Reviewer (放行审核人)	Article 22	Medical device professional background and technical training appropriate to the device risk class and technology.	Demonstrated technical competency in product standards, testing methods, and batch record review.	Must sit within the quality department or higher quality management; formally evaluated and authorized by enterprise responsible person; must be full-time (Art. 17).

Comparison: ISO 13485 vs Announcement 107 Personnel Rules

Dimension	ISO 13485:2016 (Clause 6.2)	NMPA Announcement 107 (Arts. 14–22)	Compliance Impact on Foreign MAHs
Qualification Standard	Self-defined competence based on education, training, skills, and experience.	Class II/III management representative and quality head: bachelor's or intermediate-or-higher title (Arts. 19–20). Production head: college diploma; Art. 21 has no junior-title alternative.	A quality director with long general-manufacturing experience but a non-device degree fails Arts. 19/20 unless holding an intermediate technical title.
Full-Time Employment	Allows consultants, outsourced contractors, or fractional managers.	Mandatory full-time employment contracts for 5 key operational roles.	Part-time advisory arrangements or shared regional RA/QA managers are prohibited.
Separation of Roles	Discourages conflicts of interest, but allows dual roles in smaller enterprises.	Absolute statutory ban on dual-hatting Production and Quality heads (Art. 14).	Startups must immediately hire or appoint distinct individuals to head production and quality.
Release Authority	Release authorized per documented procedures (Clause 8.2.6).	Dedicated, full-time Release Reviewer authorized in writing (Arts. 17, 22, 104).	Listing release cannot be signed off by general administrative or sales personnel.

Does ISO 13485, MDSAP, or FDA QMSR Waive Chinese GMP or an Order 53 License?

A persistent misconception among international regulatory affairs executives is that holding an ISO 13485 certificate or an MDSAP audit report waives Chinese GMP obligations.

It does not.

International audit regime	What it is	What it does not do in China
ISO 13485:2016	Voluntary international QMS standard	No statutory standing as a China manufacturing license or 107 waiver
MDSAP	Five participating authorities: US, Canada, Japan, Brazil, Australia	China is not a participating authority; an MDSAP certificate is not an NMPA GMP inspection
FDA QMSR (21 CFR Part 820)	US jurisdiction, ISO 13485:2016 by reference, effective 2 February 2026	No legal effect on Order 53 licenses or Announcement 107

China's statutory quality regime remains Order 53 (manufacturing inside the PRC; 5-year license) plus Announcement 107 (132-article GMP text) plus Order 53 Article 45 (imported-device annual QMS self-inspection via the China agent by 31 March).

Why MDSAP and ISO 13485 Do Not Waive Chinese Rules

China is Not an MDSAP Participant: The Medical Device Single Audit Program (MDSAP) includes the United States (FDA), Canada (Health Canada), Japan (MHLW/PMDA), Brazil (ANVISA), and Australia (TGA). China's NMPA is an official observer at IMDRF but is not an MDSAP participating regulatory authority. An MDSAP certificate cannot substitute for an NMPA GMP inspection, nor does it waive any requirement of Announcement 107.
US FDA QMSR Has No Extraterritorial Authority: The US FDA's transition to the Quality Management System Regulation (QMSR, 21 CFR Part 820), which explicitly incorporates ISO 13485:2016 by reference, harmonizes US regulations with international consensus. However, as analyzed in our QMSR transition analysis and our MDSAP audit guide, US administrative rules have no legal bearing on Chinese market access.
South Korea Comparison: Even jurisdictions with dedicated foreign-manufacturer GMP schemes, such as South Korea's MFDS (examined in our KGMP certification guide), require country-specific certifications that ISO 13485 cannot bypass.
Global Baseline Context: For broader foundational terminology across FDA cGMP and international quality equivalents, see our global GMP and cGMP medical device manufacturing guide and our international GMP comparison overview, both of which examine how baseline subsystem architectures differ across major regulatory regimes.

The Scope Split: Domestic Plants vs Imported Device Registrants

A crucial legal distinction exists between Order 53 Article 2 and Announcement 107 Article 2:

Order 53 (Manufacturing Licenses): Article 2 restricts the manufacturing licensing statute to manufacturing activities conducted inside the People's Republic of China. Therefore, an overseas manufacturing facility located in Germany, the United States, or Japan that manufactures an imported medical device registered in China does not apply for or hold an Order 53 Medical Device Manufacturing License.
Announcement 107 (GMP Standard): Article 2 of the official annex states:

"医疗器械注册人、备案人、受托生产企业（以下简称企业）在医疗器械设计开发、生产、质量控制与产品放行、销售和售后服务等活动过程中应当遵守本规范。" (Medical device registrants, filing entities, and entrusted production enterprises (collectively, "enterprises") shall comply with this GMP during design and development, production, quality control and product release, sales, and after-sales service.)

Article 2 names registrants, filing entities, and entrusted manufacturers. It contains no sentence exempting foreign registrants or overseas manufacturing facilities, and it is broader than "production activities" alone: design, QC/release, sales, and after-sales are in the same sentence. Foreign manufacturers holding imported medical device registrations (进口医疗器械注册证) are classified as registrants (注册人). That is still not a claim that every overseas plant must hold an Order 53 manufacturing license.

How China Regulates Foreign Registrant QMS Compliance

Because overseas plants do not hold domestic Order 53 manufacturing licenses, NMPA enforces quality compliance on imported devices through two distinct mechanisms:

Overseas On-Site Inspections (Flight Inspections): Under the Provisions for the Administration of Overseas Inspections of Drugs and Medical Devices and NMPA Order 14, NMPA dispatches inspection teams from the Center for Food and Drug Inspection (CFDI) to conduct unannounced or announced on-site audits of foreign manufacturing facilities. Inspectors evaluate the foreign facility against Chinese GMP standards (Announcement 107) and the approved Product Technical Requirements (PTR).
Mandatory Annual QMS Self-Inspection via China Agent (Order 53 Article 45): The official English of Order 53 Article 45 requires the registrant, filing entity, and contract manufacturer to conduct an annual QMS self-inspection and submit the report to the local drug regulatory department before the next 31 March. For imported devices:

"The registrant or filing entity of imported medical devices shall entrust its agent to submit self-inspection report to the drug regulatory department of the province, autonomous region, or municipality directly under the central government of the place where the agent is located."

NMPA's official Chinese interpretation of Order 53 uses 代理人 (agent), not 境内责任人, for that filing. Foreign manufacturers must complete the internal audit against Chinese GMP, compile the report, and have their China agent submit it to the provincial MPA where the agent is located.

Documented Inapplicability (Article 130)

Article 130 of the official annex has two operative sentences:

"本规范为医疗器械生产质量管理基本要求。不同类别医疗器械生产质量管理有特殊要求的，由国务院药品监督管理部门以本规范附录方式另行规定。企业可以根据所生产医疗器械特点，确定不适用本规范的具体条款，并说明不适用的合理性。"

(This GMP sets basic production-quality requirements. Where different device categories have special production-quality requirements, NMPA may stipulate them separately as appendices to this GMP. An enterprise may, according to the characteristics of the devices it manufactures, determine specific clauses that do not apply and explain the rationality of that inapplicability.)

Article 130 therefore does two things: it leaves room for later category appendices, and it allows documented inapplicability. The announcement repeals 2014 No. 64; it does not, by itself, inventory every 2014-era sterile/implantable/SaMD appendix. Treat appendix survival as an official-text check, not as a settled holding.

For example, a pure software-as-a-medical-device (SaMD) developer can document an Article 130 inapplicability justification for Chapter 4 (Premises and Facilities) and Chapter 5 (Equipment) cleanroom and sterilization requirements. The justification must be explicit, risk-backed, and ready for inspector examination. It does not waive dual release, key-person gates, or Order 53 duties that still apply.

NMPA GMP 107 30/60/90-Day Clock: Dual-Release SOP, Key-Person Roster, Quality Agreement, Then 1 November 2026

With the 1 November 2026 cutover approaching, manufacturers operating in China or contracting with Chinese CMOs need a structured remediation plan. The windows below are an operating sequence, not a second official clock in Announcement 107.

Window	Focus	Binding articles
Days 1–30	Gap audit and key-person credentialing	Separate production and quality heads (Art. 14); verify Class II/III degree/title and experience files (Arts. 19–21); full-time contracts for the five operational key posts (Art. 17); authorize in-house release reviewers (Art. 22)
Days 31–60	Dual-release procedures and quality agreements	Remove listing-release delegation (Art. 113); restated dual release (Art. 104); quality-agreement duties (Arts. 108–109); routine-test outsourcing limits (Art. 106)
Days 61–90	V&V, software confirmation, on-site CMO audits	Validation/confirmation chapter (Arts. 69–77); change- and review-triggered revalidation (Arts. 74–75); software confirmation (Art. 77); electronic records (Art. 46); on-site CMO assessment/audit (Art. 109)
1 November 2026	Operating cutover	2014 No. 64 repealed; Announcement 107 is the GMP text; released batches need dual-release records where contract manufacture applies

Detailed Tactical Milestones

Days 1–30: Governance and Personnel Remediation

Execute Article 14 Separation: Review organizational charts. If the quality manager reports to the production director, or if one individual occupies both posts, immediately separate the roles and issue formal appointment letters.
Audit Personnel Files (Articles 19–21): Retrieve verified university graduation certificates, degree verifications, professional title certificates (职称证书), and signed labor contracts for the Management Representative, Quality Head, and Production Head. Ensure the Management Representative and Quality Head hold a bachelor's degree in a medical device-related field (or intermediate title) and have at least 3 years of verified industry experience.
Contractual Status Check (Article 17): Confirm that all five statutory key personnel hold direct, full-time employment contracts with the legal entity holding the license/registration.
Authorize Release Reviewers (Article 22): Document the formal training, qualification evaluation, and written authorization from the enterprise principal responsible person appointing the in-house Release Reviewer(s).

Days 31–60: Contract Manufacturing and Dual-Release Procedures

Amend Quality Agreements (Article 108): Overhaul all existing contract manufacturing agreements. Strike out any language implying that the CMO issues final market release on behalf of the MAH. Insert explicit clauses defining the CMO's responsibility for production release and the MAH's exclusive, non-delegable responsibility for listing release.
Draft Two-Tier Release SOPs: Separate a production-release procedure for the entrusted manufacturer from a listing-release procedure for the registrant. The listing-release checklist should cover PTR compliance, UDI data, batch-record review, and deviation sign-off.
Audit Routine Testing Capabilities (Article 106): Inspect incoming, in-process, and finished-goods testing. If routine control tests are currently sent out, either bring that capability in-house or document the Article 106 high-requirement exception and qualify the contract laboratory.

Days 61–90: Validation, Software, and Site Readiness

Implement Chapter 9 V&V Master Plan: Review process validation protocols for critical manufacturing steps. Article 74 requires verification or confirmation when key materials, environment, process, equipment, or test methods that affect quality change. Article 75 requires revalidation or reconfirmation after first validation, based on quality-review analysis.
Software Confirmation and CSV (Article 77): Conduct software validation and confirmation for all automated manufacturing equipment, enterprise resource planning (ERP) systems, quality management software, and computerized testing instruments. Ensure compliance with electronic signature and audit trail requirements under Article 46.
Execute On-Site CMO Audits (Article 109): Dispatch MAH quality auditors to conduct comprehensive, multi-day on-site quality audits of all domestic CMOs. Document the audit findings, issue corrective action requests, and archive the complete audit dossier.

What Does This Cost: No New Announcement-107 Tariff Versus Order 53 License Work, Dual-Release Staff, and On-Site CMO Audits?

A common inquiry from corporate finance and regulatory planning teams is: "What is the official NMPA government fee for Announcement 107 compliance?"

The answer is zero. Announcement No. 107 is an administrative normative document that publishes a technical standard; NMPA levies no statutory fee or government tariff for publishing, adopting, or inspecting against Announcement 107.

However, operational compliance carries distinct cost categories. Announcement 107 itself publishes no RMB schedule. The table below separates official-text facts from implementation costs that depend on provincial fee rules, payroll, and supplier work:

Expense element	Classification	Underlying instrument	Source basis	What to budget
Announcement 107 tariff	Government tariff	Announcement 107 / annex	Official announcement and 132-article annex name no NMPA application fee for adopting the GMP text	0 RMB in the 107 file
Order 53 manufacturing license / renewal	Statutory government fee	Order 53 Arts. 4, 14, 17	Provincial pricing authorities, not a national 107 tariff. This article does not invent a national RMB figure	Check the issuing provincial MPA schedule; some provinces publish a waiver or a low administrative fee
Full-time production vs quality heads	Operational payroll	Arts. 14, 17, 20–21	Implementation cost, not an official fee	Separate full-time heads who meet the Class II/III degree/title and experience bars
In-house listing-release reviewer	Operational payroll	Arts. 17, 22, 113	Implementation cost	Full-time MAH-side reviewer; listing release cannot be bought as a CMO signature
On-site CMO assessment and periodic audit	Operating compliance	Art. 109	Required on-site work; travel and auditor time are manufacturer costs	Pre-contract on-site assessment plus periodic on-site QMS audit during the contract
Routine in-house QC capability	CapEx / laboratory	Art. 106	Generally no routine-test outsourcing; specialized high-requirement tests may still go to a qualified lab	Equipment or justified qualified-institution contracts, not a 107 tariff
Software confirmation / electronic records	Technical consulting / internal V&V	Arts. 46, 77	Implementation cost	Confirm software that affects product quality; keep electronic-record integrity

For government registration-fee context (a different instrument from manufacturing-license fees), see the China row in our medical device registration cost by country guide. Those NMPA product-registration amounts are not an Announcement 107 fee.

The Public UDI Data Trap: Identifiers Are Not Manufacturing Licenses

In evaluating market size and manufacturing compliance, market research reports often point to public data from NMPA's Unique Device Identification (UDI) system as proof of licensed manufacturing capacity.

This is a fundamental methodological error.

In the official NMPA UDI database (public snapshot extract dated 2 September 2026), there are 6,139,557 normalized ready device-identifier records:

Medical devices (器械): 5,900,360 records
In vitro diagnostic reagents (体外诊断试剂): 239,640 records

These 6.1 million rows are product-identifier records linked to registration and filing certificates. The public extract includes manufacturer-name and registration-number fields, but no GMP-compliance, manufacturing-license, plant-address, or audit-outcome fields.

Citing 6.1 million UDI identifier rows as an inventory of "GMP-compliant Chinese manufacturing plants" is false. A single medical device manufacturing plant may produce hundreds of individual UDI product codes across various sizes, pack counts, and catalog numbers. As shown in our China NMPA Device Registration Database Analysis, product approvals and packaging identifiers represent market clearances, not audited manufacturing facility headcounts.

Eight Critical Failure Modes Under Announcement 107

Failure Mode	Regulatory Violation	Operational Impact	Enforcement Consequence
1. Delegating Listing Release to the CMO	Article 113 (不得委托其他企业进行)	Registrant treats the CMO's factory release as market release.	Inspection nonconformity against Art. 113; products should not enter the market without the registrant's own listing-release signature. This article does not treat that finding as an automatic registration revocation.
2. Dual-Hatting Production & Quality Heads	Article 14 (不得互相兼任)	One person occupies both production-head and quality-head posts.	Direct GMP/personnel nonconformity; likely a license-application or renewal obstacle under Order 53's GMP inspection.
3. Part-Time Key Personnel	Article 17 (全职人员)	External consultants or shared fractional executives occupy the five operational key posts.	Audit nonconformity; inspectors can require full-time appointments.
4. Unqualified Class II/III Quality Leadership	Articles 19 and 20	Quality head or management representative lacks the Class II/III degree/title bar or the required device experience.	Personnel disqualification during review; license application or QMS inspection can fail.
5. Claiming ISO 13485 or MDSAP as a Waiver	Order 53, Art. 25; Announcement 107, Art. 2	Firm presents ISO/MDSAP paper as a China GMP or license waiver.	Inspectors audit against the 132 articles; the certificate is not a substitute.
6. Outsourcing Routine QC Testing	Article 106 (一般不得进行委托检验)	Routine incoming, in-process, or finished-product control tests are contracted out without the Art. 106 high-requirement exception.	Nonconformity for missing in-house routine-test capability. Specialized high-requirement tests may still go to a qualified institution.
7. Paper-Only Desk Audits of CMOs	Article 109 (现场评估 / 现场审核)	Registrant uses questionnaires instead of on-site assessment and periodic on-site QMS audit.	Chapter 12 nonconformity; MAH oversight of entrusted manufacture is incomplete.
8. Missing Imported-Device Self-Inspection	Order 53, Article 45	Foreign registrant misses the agent's 31 March QMS self-inspection filing.	Provincial filing gap; the English Order 53 text itself does not specify a fine in Article 45.

Frequently Asked Questions

Does NMPA GMP Announcement 107 already replace the 2014 GMP, or is 1 November 2026 still the switch date?

1 November 2026 is the official legal switch date. CFDA Announcement No. 64 of 2014 remains the GMP text in force until 31 October 2026. On 1 November 2026, Announcement No. 64 is repealed simultaneously with Announcement 107 taking effect. Neither Announcement 107 nor Article 132 grants any subsequent grace period. Manufacturers should still prepare now: the announcement does not freeze 2026 provincial surveillance practice, and unannounced inspections on or after 1 November 2026 will apply Announcement 107.

Is dual release new in Announcement 107, or did Order 53 Article 34 already require it?

Dual release is not new. SAMR Decree No. 53 (Order 53), promulgated in March 2022 and effective since 1 May 2022, established the statutory dual-release framework in Article 34, requiring the contract manufacturer to perform production release and the registrant/filing entity to perform marketing release. Announcement 107 Articles 104 and 113 provide operational depth to this requirement, formally specifying the scope of production release versus listing release and establishing an absolute statutory ban on delegating listing release to the CMO.

Can a China contract manufacturer perform listing (marketing) release for the registrant?

No. Listing release cannot be delegated. Article 113 states that listing release shall be completed by the entrusting party itself and shall not be delegated to another enterprise (产品上市放行由委托方自行完成，不得委托其他企业进行). The contract manufacturer issues production/factory release (生产放行), but the product may be placed on the market only after the registrant's own authorized release personnel sign the listing release.

Do ISO 13485-competent quality managers who lack a bachelor's degree or three years of experience still satisfy Articles 19–20 after 1 November 2026?

No, not on the Class II/III statutory bars. ISO 13485 Clause 6.2 lets the organization define competence. For Class II and Class III enterprises, Article 19 requires the management representative to hold a bachelor's degree or higher in a medical-device-related specialty or an intermediate or higher technical title, and generally (原则上) at least three years of relevant quality, production, or technical-management experience. Article 20 requires the quality head to hold the same Class II/III degree/title bar and shall have at least three years of medical-device production or quality-management experience (no 原则上 hedge on that sentence). Class I enterprises have a lower college-diploma bar in Articles 19–20. A quality manager who is ISO-competent but misses those statutory credentials does not meet the 107 text.

Must an overseas plant of an imported device obtain a China manufacturing license because GMP Article 2 names registrants?

No. Order 53 Article 2 restricts the manufacturing-license statute to activities inside the PRC. Overseas plants producing imported devices do not hold an Order 53 manufacturing license. Foreign registrants remain in GMP Article 2's named population and must have their China agent submit the annual QMS self-inspection report to the provincial regulator where the agent is located, before 31 March, under Order 53 Article 45.

Does Announcement 107 add a new NMPA government fee, and may we treat 6.1 million UDI rows as a plant census?

No on both counts. Announcement 107 is an administrative normative document and levies zero statutory government fees. Any government fees associated with manufacturing oversight stem from provincial fee schedules for Order 53 manufacturing licenses. Furthermore, the 6,139,557 ready records in the 2 September 2026 NMPA UDI public extract represent registered device packaging identifiers, not manufacturing facilities. The UDI database contains no fields for GMP compliance, facility licenses, or plant inspections, and cannot be used as a census of GMP-compliant manufacturing plants.

How Pure Global Supports China NMPA Registration and GMP Compliance

Navigating China's evolving medical device regulatory framework—from initial device classification and product technical requirement (PTR) formulation to Order 53 manufacturing licensing and Announcement 107 GMP compliance—requires dedicated, on-the-ground technical execution.

Pure Global provides end-to-end regulatory affairs, quality system compliance, and localized representation for international medical device manufacturers entering China and major global healthcare markets.

Pure Global's dedicated China regulatory practice assists manufacturers to:

Act as China agent for imported-device post-market filings: Managing regulatory correspondence with NMPA and provincial MPAs, and compiling and submitting the mandatory annual QMS self-inspection report under Order 53 Article 45.
Execute Announcement 107 GMP Gap Assessments: Auditing facility quality systems, standard operating procedures, and personnel credentials against the 15 chapters and 132 articles of Announcement 107 to identify remediation needs prior to 1 November 2026.
Establish Dual-Release Protocols: Structuring compliant, legally defensible contract manufacturing quality agreements under Articles 108 and 109, and drafting segregated Production Release and Listing Release SOPs that comply with Article 113's non-delegation mandate.
Conduct On-Site CMO Audits: Performing independent, on-site technical capability assessments and periodic supplier surveillance audits of Chinese contract manufacturers to satisfy Article 109 requirements.
Manage Product Registrations and Manufacturing Licenses: Preparing full NMPA registration dossiers, managing localized type testing, formulating PTR documents, and guiding domestic entities through Order 53 manufacturing license applications and 5-year renewals against transparent service pricing.

To audit your Chinese manufacturing operations, overhaul your contract manufacturing agreements, or prepare for the 1 November 2026 cutover, contact Pure Global's regulatory team.

Pure Global provides professional regulatory affairs, clinical, and quality consulting services. Pure Global is an independent advisory firm, not the National Medical Products Administration (NMPA) or a Chinese state competent authority, and does not issue statutory regulatory approvals.

Sources

国家药监局关于发布医疗器械生产质量管理规范的公告（2025年第107号） — National Medical Products Administration (NMPA), issued 4 November 2025. Document Index: FGWJ-2025-10085. Sets the 1 November 2026 effective date and repeals CFDA Announcement No. 64 of 2014.
医疗器械生产质量管理规范（2025年第107号公告附件 DOC） — NMPA, retrieved 8 September 2026. Official annex: 15 chapters and 132 articles.
Announcement of the NMPA on the Release of the Good Manufacturing Practice for Medical Devices (No. 107) — Official English Announcement, updated 7 November 2025. Confirms the 1 November 2026 implementation date and simultaneous repeal of Announcement No. 64 of 2014.
Revision and Release of the Good Manufacturing Practice for Medical Devices — Official English News, updated 7 November 2025. Details the 15 chapters, 132 articles, three new chapters (Quality Assurance, Validation & Verification, Contract Manufacture & Outsourcing), and five core characteristics.
国家药监局修订发布《医疗器械生产质量管理规范》 — Official Chinese News, index XZXK-2025-10247, published 4 November 2025.
Provisions for Supervision and Administration of Medical Device Manufacturing (SAMR Decree No. 53) — State Administration for Market Regulation (SAMR) / NMPA, promulgated 10 March 2022, effective 1 May 2022. Territorial manufacturing licensing (Art. 2), 5-year licenses (Art. 14), license-renewal window (Art. 17), dual release (Art. 34), and annual self-inspection by 31 March (Art. 45). Official Chinese interpretation (22 March 2022): https://www.nmpa.gov.cn/xxgk/zhcjd/zhcjdylqx/20220322180552159.html
China NMPA UDI Public Data Extract (udi.nmpa.gov.cn) — NMPA Unique Device Identification Database. Public extract snapshot as of 2 September 2026 (6,139,557 ready records: 5,900,360 medical devices, 239,640 IVDs). Used as a data contrast demonstrating that UDI identifier records are not a census of GMP-compliant manufacturing plants.
Regulations on the Supervision and Administration of Medical Devices (State Council Order No. 739) — State Council of the People's Republic of China, promulgated 9 February 2021, effective 1 June 2021. Primary statutory framework governing medical devices in China.