Vietnam Medical Device Registration Guide (2026): Complete Process, Fees, Timeline & Requirements

Overview of Vietnam's Medical Device Market

Vietnam is one of the fastest-growing medical device markets in Southeast Asia. The country's medical device market is valued at approximately $2.5 billion and growing steadily, making it an attractive expansion target for international manufacturers. Vietnam's IVD sector is also expanding rapidly alongside broader healthcare investment.

Vietnam's regulatory framework is modernizing rapidly, governed primarily by Decree No. 98/2021/ND-CP (effective January 1, 2022) and its amendment Decree No. 07/2023/ND-CP. The regulatory authority is the Infrastructure and Medical Device Administration (IMDA) under the Ministry of Health (MOH) — renamed from the former Department of Medical Equipment and Construction (DMEC) in January 2025.

Vietnam is aligning its regulations with the ASEAN Medical Device Directive (AMDD), and the Common Submission Dossier Template (CSDT) is now required for most device classes.

Regulatory Framework

Key Legislation

Regulation	Effective Date	Purpose
Decree No. 98/2021/ND-CP	January 1, 2022	Primary framework for medical device management
Decree No. 07/2023/ND-CP	March 3, 2023	Extends import license validity, clarifies CSDT requirements
Circular No. 05/2022	2022	Lists products requiring registration before import
Decree No. 111/2021	2021	Updates labeling requirements
Circular No. 44/2025	November 2025	Updated administrative procedures and regulatory documentation
Circular No. 57/2025/TT-BYT	February 15, 2026	Classification of devices for procurement by technical standards and quality
Notice No. 645/TB-HTTB	July 1, 2025	50% reduction in registration fees through December 31, 2026
Circular No. 64/2025/TT-BTC	2025	Formalizes the 50% fee reduction for appraisal fees

Regulatory Authority

Infrastructure and Medical Device Administration (IMDA) — under the Ministry of Health (MOH). IMDA handles:

• Registration and licensing of Class C and D devices
• Regulatory oversight and inspections
• Corrective and enforcement actions
• Post-market surveillance for higher-risk devices

Provincial Departments of Health — handle notification of Class A and B devices.

Device Classification

Vietnam classifies medical devices into four classes based on risk, consistent with the ASEAN framework:

Class	Risk Level	Review Pathway	Review Authority
Class A	Low risk	Notification	Provincial Department of Health
Class B	Low to moderate risk	Notification	Provincial Department of Health
Class C	Moderate to high risk	Product Registration	MOH (IMDA)
Class D	High risk	Product Registration	MOH (IMDA)

Classification Responsibility

Under Decree 98, the Registration Holder (not a certified classification agent) is responsible for classifying the device. This is a change from the previous system under Decree 36, which required classification by a licensed Vietnamese classification organization.

Registration Pathways

Class A and B Devices — Notification Process

Class A and B devices follow a notification (declaration) process:

1. Prepare the notification dossier
2. Submit to the Provincial Department of Health via the IMDA digital portal
3. For devices with reference country approval (FDA, CE, TGA, etc.), notification is typically approved within 1 week
4. Without reference country approval, processing takes 3–5 business days to a few weeks

This is an administrative review — no technical assessment is performed.

Class C and D Devices — Product Registration

Class C and D devices require full product registration with the MOH through the IMDA portal. Two pathways are available:

Fast-Track Route (10 business days)

Available when the device has approval from a recognized reference country:

• US FDA
• EU member states (CE marking)
• Japan (PMDA/MHLW)
• Australia (TGA)
• Health Canada
• UK (MHRA)
• Switzerland
• China (NMPA)
• South Korea (MFDS)

Requirement: One Free Sale Certificate (FSC) or Market Authorization from any reference country.

Standard Route (40–45 business days)

For devices without reference country approval, a full technical review is conducted.

Registration Fee Comparison (Current 50% Discount vs. Standard)

Device Class	Standard Fee	Discounted Fee (50%)	Standard Review Time
Class A	VND 1,000,000 (~$43)	VND 500,000 (~$21)	3–5 days
Class B	VND 3,000,000 (~$130)	VND 1,500,000 (~$65)	3–5 days
Class C	VND 6,000,000 (~$260)	VND 3,000,000 (~$130)	10–60 days
Class D	VND 6,000,000 (~$260)	VND 3,000,000 (~$130)	10–60 days

The 50% discount is valid through December 31, 2026. Plan submissions now to take advantage.

Registration Validity

Under Decree 98, all registration numbers (circulation numbers) are valid indefinitely — this is a significant improvement from the previous system where Class B, C, and D registrations expired after 5 years.

The only exception is registration numbers granted under emergency registration procedures, which have limited validity.

Who Can Register a Medical Device in Vietnam

Only companies registered locally in Vietnam with a valid Establishment License from the Local Department of Planning and Investment may register medical devices. This includes:

• Vietnamese enterprises, cooperatives, and household businesses that own or trade medical devices
• Standing representative offices of foreign traders authorized by device owners

Options for Foreign Manufacturers

Foreign manufacturers have three options:

1. Establish a Vietnamese subsidiary — Register with the local Department of Planning and Investment, obtain investment certificates and business license. Most control but highest cost and administrative burden.

2. Appoint a local importer or distributor — Use an existing Vietnamese company with a valid establishment license. Fastest option but you depend on the distributor's compliance infrastructure.

3. Appoint an independent third-party MAH — Appoint a regulatory services firm as your Marketing Authorization Holder (MAH). The MAH submits applications, acts as liaison with IMDA, and can issue Letters of Authorization to multiple distributors.

Required Documentation

Legal Documents

• Business registration certificate or establishment license of the Registration Holder
• Power of Attorney from the manufacturer to the Registration Holder
• Certificate of Free Sale (CFS) from the country of origin
• ISO 13485 certificate for the manufacturing facility (mandatory per Article 23 of Decree 98)

Technical Documents

Document	Class A/B	Class C/D
Classification result	Required	Required
Technical brief (device description, design, specifications)	Required	Required
Instructions for Use (Vietnamese)	Required	Required
Labeling and packaging	Required	Required
Product catalogue	Required	Required
Clinical trial summary	Not typically required	Required for invasive or implanted devices
Risk analysis	Recommended	Required
Performance testing reports	If applicable	Required
Biocompatibility data	If applicable	Required

Language Requirements

All documents submitted to Vietnamese authorities must be in Vietnamese or accompanied by a certified Vietnamese translation. Technical documents in English are generally accepted, but labeling and IFU must be in Vietnamese.

Step-by-Step Registration Process

Step 1 — Classify Your Device

Determine the risk class (A–D) based on the intended use and following the classification rules in Decree 98. The Registration Holder performs this classification.

Step 2 — Appoint a Local Representative

If you are a foreign manufacturer, engage a Vietnamese Registration Holder/MAH before proceeding.

Step 3 — Prepare Your Dossier

Compile all required legal and technical documents. Ensure ISO 13485 certificate covers the manufacturing facility. Translate labeling and IFU into Vietnamese.

Step 4 — Submit Application

• Class A/B: Submit notification to the Provincial Department of Health via the IMDA digital portal
• Class C/D: Submit product registration dossier to MOH via the IMDA digital portal

Step 5 — MOH Review

The reviewing authority will:

• Acknowledge receipt of a complete application and fee payment
• For Class C/D: respond within 30 days of receiving a complete application
• If incomplete, issue a request for modification within 25 days
• Applicants have up to 5 chances to revise submissions
• If unsatisfactory after 5 attempts or not resubmitted within 90 days, the application is rejected

Step 6 — Registration Number Issuance

Upon approval, the device is issued a circulation number (registration number) that is valid indefinitely.

Step 7 — Import and Market

Present the registration number during customs clearance. The Registration Holder/MAH assists with importation.

ISO 13485 Requirement

Per Article 23 of Decree 98, imported medical devices must be manufactured in a facility that holds a valid ISO 13485 certificate. This is a mandatory prerequisite — there is no exemption for any device class.

Circular 57/2025: New Procurement Classification (Effective 2027)

On December 31, 2025, Vietnam's MOH issued Circular No. 57/2025/TT-BYT, which introduces a new six-group classification framework for medical device procurement and tendering. While this doesn't change the registration process, it will affect how devices compete in public tenders starting January 1, 2027.

Devices are classified into six groups based on:

1. Technical standard compliance (certification, assessment, or self-declaration)
2. Quality certification (whether the device is on Vietnam's "Golden List" of approved products)

Group	Technical Standard	Quality Tier	Competitive Position
Group 1	Certification required	Golden List	Highest standard — premium tier
Group 2	Certification required	Open	Strong technical, broader quality source
Group 3	Certification or assessment	Golden List	Moderate standards, high quality
Group 4	Certification or assessment	Open	Medium requirements
Group 5	Any method	Golden List	Flexible technical, high quality
Group 6	Any method	Open	Lowest entry requirements

Implication: Devices with FDA/CE approval and strong technical documentation will qualify for higher groups, giving them a competitive advantage in Vietnamese hospital procurement tenders.

Common Challenges and How to Avoid Them

1. Incomplete Dossiers

The most common cause of delays. Ensure every required document is included before submission. You only get 5 revision attempts.

2. Missing ISO 13485 Certificate

Article 23 makes ISO 13485 certification mandatory for the manufacturing facility. No exemption. Verify your certificate covers the exact manufacturing site listed in the application.

3. Incorrect Classification

While the Registration Holder now performs classification, errors can lead to the wrong pathway being used. Classify conservatively — if in doubt, seek regulatory advice.

4. No Reference Country Approval

Without reference country approval, Class C/D registration shifts to the standard route (40–45 days vs. 10 days). If possible, obtain approval from at least one recognized reference country before applying.

5. Language Issues

IFU and labeling must be in Vietnamese. Poor translations are flagged during review. Use qualified medical translators.

Total Cost Estimate

Cost Item	Estimated Range
Government registration fee (Class A, discounted)	~$21
Government registration fee (Class B, discounted)	~$65
Government registration fee (Class C/D, discounted)	~$130
Local representative/MAH fees (annual)	$2,000–$10,000
Regulatory consultant (dossier preparation)	$3,000–$15,000
Document translation (English to Vietnamese)	$1,000–$5,000
Testing (if required)	$5,000–$25,000
Total estimated cost per device	$6,000–$35,000

Key Takeaways

• All registration numbers are now valid indefinitely under Decree 98 — no more 5-year renewals for Class B–D devices
• 50% fee reduction is in effect through December 31, 2026 — submit now to save
• ISO 13485 is mandatory for the manufacturing facility (Article 23)
• Reference country approval enables fast-track (10 business days for Class C/D)
• Foreign manufacturers need a local Registration Holder — three options available
• Classification is self-performed by the Registration Holder under Decree 98
• Plan 2–6 months for registration depending on device class and pathway
• Circular 57/2025 introduces procurement classification starting January 2027 — plan accordingly

2026 Regulatory Updates You Should Know

Consolidated Decree 98 (March 2026)

On March 6, 2026, Vietnam's MOH issued Consolidated Document No. 08/VBHN-BYT, which merges Decree 98/2021 and its amendments (including Decree 07/2023) into a single authoritative reference. While no new requirements were introduced, companies should ensure their internal regulatory references use the consolidated version to avoid relying on outdated decree texts. The consolidated document also removes the previous requirement to publicly disclose advertising information on the Medical Device Management Portal.

Circular 57/2025 — Procurement Classification (Effective 2027)

Starting January 1, 2027, medical devices in Vietnamese public tenders will be classified into six groups based on two criteria: technical standard compliance (certification, assessment, or self-declaration) and quality certification (whether the device is on Vietnam's "Golden List" of approved products). Devices with FDA/CE approval and strong technical documentation will qualify for higher groups, giving them a competitive advantage in hospital procurement. Prepare documentation now to ensure favorable group placement.

IVD Classification Crackdown (October 2025)

Vietnam's MOH has begun more strictly enforcing IVD device classifications. Companies that previously classified IVD products at a lower risk level may receive reclassification requests. Review your IVD classifications to ensure they align with current MOH expectations.

Frequently Asked Questions

How long does medical device registration take in Vietnam?

Class A/B notifications: 3–5 business days (1 week with reference country approval). Class C/D fast-track: 10 business days. Class C/D standard route: 40–45 business days. Budget 2–6 months total including preparation time.

Do I need a Certificate of Free Sale?

Yes. A valid CFS from the country of origin is required for imported medical devices.

Which countries are recognized as reference countries for fast-track?

US (FDA), EU member states (CE), Japan (PMDA), Australia (TGA), Canada (Health Canada), UK (MHRA), Switzerland, China (NMPA), and South Korea (MFDS).

Can I use my ASEAN CSDT dossier?

Yes. Vietnam accepts the CSDT format, aligned with the ASEAN Medical Device Directive. Decree 07/2023 implemented CSDT requirements starting January 2023.

Is a local clinical trial required?

Not typically. Clinical trial data from reference countries is generally accepted. However, the MOH may request additional clinical data for certain high-risk devices or devices where population-specific factors are relevant.

Can I change my Registration Holder?

Yes, but the process requires re-registration of the device under the new holder. The previous registration number may need to be transferred or a new application submitted.

Does Vietnam require UDI for medical devices?

Vietnam is progressively implementing UDI requirements in alignment with ASEAN harmonization efforts. Check current requirements with your local representative at the time of application.

What post-market obligations exist?

Post-market quality control applies to all imported and marketed devices. Adverse event reporting and field safety corrective actions must be reported to the MOH. The IMDA has expanded enforcement responsibilities under Circular 44/2025, particularly for Class C and D devices.