India G.S.R. 743(E): Outsourced Sterilization Labels, 14 Feb 2027 Clock & Ninth Schedule

Guide to CDSCO G.S.R. 743(E) Medical Devices Second Amendment Rules 2026: Rule 44(p) label prefixes, 14 Feb 2027 clock, Ninth Schedule fees, and loan licences.

On August 19, 2026, the Ministry of Health and Family Welfare (MoHFW) published G.S.R. 743(E), titled the Medical Devices (Second Amendment) Rules, 2026, in the Gazette of India Extraordinary (Part II, Section 3, Sub-section (i), No. 677; CG-DL-E-21082026-275637). Notified under file number F. No. X.11035/112/2024-DR and signed by Harsh Mangla, Joint Secretary, this statutory instrument introduces targeted, consequential amendments to the foundational Medical Devices Rules, 2017 (MDR-2017).

The amendment has triggered immediate confusion across international and domestic MedTech regulatory affairs teams. Five days after the gazette publication, on August 24, 2026, the Press Information Bureau (PIB) issued a press release (PRID 2302665) claiming that under amended provisions, medical device manufacturers outsourcing sterilization will "no longer be required to obtain a separate loan license." Trade commentary and regulatory consultants quickly circulated summaries declaring loan licences abolished.

However, the actual statutory text of G.S.R. 743(E) does not repeal loan licensing. Instead, it amends MDR-2017 in four specific ways:

It inserts Rule 44(p), requiring manufacturers who outsource sterilization to another licensed facility to mention that sterilization site's licence number on the device label, preceded by one of three English-gazette prefixes. The duty uses "should" until the delayed proviso makes compliance mandatory on 14 February 2027.
Amending Rule 5 attaches that delayed proviso to the Rule 44(o) small-device cross-reference: compliance with clause (p) shall be mandatory with effect from six months from the date of the notification (14 August 2026).
Amending Rule 6 inserts a Ninth Schedule specifying government medical device testing laboratory evaluation fees, which new Rule 19(3) and amended Rule 69 (Form MD-33) then point to.
It inserts a definition of "Certificate of Registration" in Rule 3(ya) (Forms MD-2, MD-40, and MD-42) and omits "of a licencee" from Rule 3(j).

This operating guide breaks down the legal text of G.S.R. 743(E), separates the official gazette requirements from ministry press communications, clarifies the statutory clock, details the Ninth Schedule testing fee schedule, and outlines an actionable 30/60/90-day implementation plan.

This guide builds upon MedDeviceGuide's broader Indian regulatory analysis, including the foundational India CDSCO registration guide, the recent CDSCO medical device software (MDSW) guidance, and the India approved medical devices market analysis.

Direct Answer: What Changed Under G.S.R. 743(E) and What Is the Planning Clock?

G.S.R. 743(E) is not a new product registration framework, not a new manufacturing licence category, and not an adoption of a new quality standard. It is an operational rewrite of two distinct facets of MDR-2017: device labeling for outsourced sterilization and government laboratory testing tariffs.

To plan compliance without disruption, regulatory teams must maintain strict clarity regarding three statutory dates and one operational deadline:

Regulatory milestone	Date	Legal significance	Statutory source
Notification date	14 August 2026	Date the statutory order was signed by MoHFW (F. No. X.11035/112/2024-DR). Serves as the statutory trigger for the six-month labeling transition clock.	Preamble to G.S.R. 743(E)
Gazette publication date	19 August 2026	Date of official publication in the Gazette of India Extraordinary (No. 677). Under Rule 1(ii), this is the general coming-into-force date for all provisions unless specified otherwise.	Rule 1(ii), G.S.R. 743(E)
Ninth Schedule fee effective date	19 August 2026	New laboratory test and evaluation fees take legal effect under inserted Rule 19(3) and amended Rule 69, with no delayed proviso.	Rule 1(ii) and amending Rules 6–8, G.S.R. 743(E)
Mandatory Rule 44(p) labeling deadline	14 February 2027	Exactly six calendar months from the August 14, 2026 notification date. From this day onward, sterile devices outsourcing sterilization must bear the site licence number on the label.	Proviso to Rule 44 amendment, G.S.R. 743(E)

The Core Rule: In-House vs. Outsourced Sterilization

The labeling duty introduced in G.S.R. 743(E) turns entirely on whether sterilization is executed in-house or outsourced:

Outsourced sterilization: If a medical device manufacturer outsources sterilization to another facility that holds a valid licence to carry out sterilization of medical devices, the device label should display that sterilization site's licence number preceded by one of three legally prescribed prefixes. Compliance becomes strictly mandatory on 14 February 2027.
In-house sterilization: If a manufacturer performs sterilization within its own licensed manufacturing site (for example under Form MD-5, MD-7, or MD-9), the English gazette text of Rule 44(p) does not apply. The manufacturer continues to print its own manufacturing licence number under Rule 44(m), or the import licence particulars under Rule 44(n) for imported devices, and does not invent a second sterilization-site number. That text does not say a foreign establishment registration, 510(k) number, or CE certificate is a substitute sterilization-site licence.

Is G.S.R. 743(E) a New Manufacturing Licence, or a Label-and-Laboratory-Fee Rewrite of MDR-2017?

A frequent misconception circulating in regulatory briefings is that G.S.R. 743(E) creates a new "contract sterilization licence" or alters the fundamental licensing architecture under MDR-2017. It does neither.

To understand its precise scope, consider the full structure of the amending instrument across its operative sections:

Amending section of G.S.R. 743(E)	MDR-2017 provision affected	Nature and scope of amendment
Rule 1	Commencement	Rule 1(ii): these rules, unless specified otherwise, come into force on the date of final publication in the Official Gazette (19 August 2026).
Rule 2	Rule 3(j)	Omits the words "of a licencee".
Rule 3	Rule 3(ya)	Inserts "Certificate of Registration" as a registration certificate in Form MD-2, Form MD-40, and Form MD-42, as the case may be.
Rule 4	Rule 44(p)	Inserts clause (p) after clause (o): outsourced-sterilization site licence number on the device label with the three English prefixes.
Rule 5	Rule 44(o), plus the delayed proviso	Substitutes "(m) and (p)" for "and (m)" in the small-device must-include list. The following proviso makes compliance with clause (p) mandatory six months from the date of this notification.
Rule 6	Ninth Schedule	Inserts the Ninth Schedule ("Fee for test or evaluation", see Rules 19 and 69) after the Eighth Schedule.
Rule 7	Rule 19(3)	Inserts Rule 19(3): fees for test or evaluation shall be those specified in the Ninth Schedule.
Rule 8	Rule 69	After the words "Form MD-33", inserts "accompanied with a fee specified in the Ninth Schedule".

Definitional Adjustments: Rule 3(j) and Rule 3(ya)

Rule 2 of G.S.R. 743(E) amends Rule 3(j) of MDR-2017 by omitting the phrase "of a licencee". Under the original 2017 rules, various administrative references presupposed that an establishment held a traditional manufacturing or import licence.

Rule 3 of G.S.R. 743(E) inserts clause (ya) into Rule 3:

"Certificate of Registration" means a registration certificate granted by the State Licensing Authority or the Central Licensing Authority in Form MD-2, Form MD-40 and Form MD-42 as the case may be.

Those three forms are existing registration certificates, not a new manufacturer pathway:

Form MD-2: Certificate of Registration for a Notified Body.
Form MD-40: Certificate of registration of a Medical Device Testing Laboratory (to carry out test or evaluation on behalf of a manufacturer).
Form MD-42: Registration certificate to sell, stock, exhibit or offer for sale or distribute a medical device (wholesalers, distributors, and retailers under the 2022 sale-registration amendments).

This is a definitional clean-up. It does not create a new registration portal, does not impose fresh filing fees on manufacturers, and does not alter the medical device classification system. It is also not a Unique Device Identification (UDI) system.

What Did Rule 44(p) Actually Add, and Which Three Prefixes Does the English Gazette Print?

The core operational change for manufacturers, packaging engineers, and regulatory labeling leads is in Rules 4 and 5 of G.S.R. 743(E).

The Amending Language

Two separate amending paragraphs touch Rule 44:

Rule 4 inserts clause (p) after clause (o).
Rule 5 amends clause (o), which is the small-device must-include list, not a permission to omit particulars. Original Rule 44(o) requires small-sized devices on which information cannot be printed legibly to still carry the information in clauses (a), (b), (c), (d), (e), (g), (k), and (m). Rule 5 substitutes "(m) and (p)" for "and (m)", so those small labels must also carry clause (p) once it is mandatory. The delayed-force proviso is attached to this Rule 5 paragraph, not printed inside clause (p) itself.

The English gazette inserts clause (p) as follows:

(p) In case of medical device manufacturer who outsourced the sterilization activity at the site of another facility having valid license to carry out sterilization process of medical devices, the license number of the sterilization site should be mentioned on label of the device. The sterilization site license number by preceding the words "Sterilization sites Manufacturing License Number" or "Ster. Mfg. Lic. No." or "S.M. L."

The Rule 5 proviso then states:

Provided, the compliance with clause (p) shall be mandatory with effect from six months from the date of this notification.

The Three Prescribed Prefix Formats

The English gazette text specifies exactly three permissible prefix options. Labeling artwork must conform strictly to one of these three strings. The pack-size column below is an operational suggestion for artwork planning, not a gazette assignment of prefixes to pack types.

Option	Exact statutory prefix	Case & spacing requirements	Operational suggestion (not gazette)
Option 1 (Full)	`Sterilization sites Manufacturing License Number`	Title case; American spelling of "License" as printed in the official gazette; spaces between words.	Large primary packaging, master shippers, intermediate cartons, procedure trays with ample artwork real estate.
Option 2 (Standard Abbreviation)	`Ster. Mfg. Lic. No.`	Periods after abbreviations; single space after each period; "Ster." and "Mfg." capitalized.	Standard product cartons, sterile barrier pouches, blister packs, and standard shelf packaging.
Option 3 (Compact String)	`S.M. L.`	Critical spacing: Period after S, period after M, space, followed by L and period (`S.M. L.`).	Small-format packaging that relies on Rule 44(o), including ampoules, vial collars, and narrow pouches.

The following strings are illustrative only (the licence number MFG/MD/2024/000987 is invented for layout). Substitute the contract sterilizer's current MDR-2017 licence number:

Format 1: Sterilization sites Manufacturing License Number MFG/MD/2024/000987
Format 2: Ster. Mfg. Lic. No. MFG/MD/2024/000987
Format 3: S.M. L. MFG/MD/2024/000987

Critical Labeling Pitfalls to Avoid

Do NOT use Mfg. Lic. No. alone: Some early consultant summaries incorrectly suggested that manufacturers could simply use "Mfg. Lic. No." for the contract sterilizer. That string is not one of the three prefixes in clause (p). In MDR-2017 Rule 44(m), "Manufacturing Licence Number" or "Mfg. Lic. No." or "M. L" identifies the legal manufacturer's own licence (except for imported devices, which use Rule 44(n)). Using the manufacturer's prefix for the sterilization site creates ambiguity between the legal manufacturer and the processing site.
Preserve the internal space in Option 3: The official English gazette text prints S.M. L. with a space between S.M. and L.. Do not condense this to S.M.L. or SML.
Do NOT omit the manufacturer's own licence number: Rule 44(p) is in addition to, not in place of, Rule 44(m) (domestic manufacturing licence number) or Rule 44(n) (import licence particulars, including Form MD-15).
Small packs still need clause (p) once it is mandatory: Because Rule 44(o) is a must-include list, adding (p) there means a small-sized outsourced-sterilization device cannot drop the sterilization-site number on the ground that the pack is too small.

When Is Clause (p) Mandatory: 14 August 2026, 19 August 2026, or 14 February 2027?

Regulatory professionals frequently ask: If G.S.R. 743(E) came into force on 19 August 2026, why aren't state drug inspectors seizing products today for missing sterilization licence numbers?

The answer lies in the legal interaction between general commencement rules and specific statutory provisos.

General Force Date vs. Delayed Proviso

Rule 1(ii) of G.S.R. 743(E) sets the general baseline:

"These rules unless specified otherwise, come into force on the date of their final publication in the Official Gazette."

That publication date is 19 August 2026. This general rule immediately brought into effect:

The omission of "of a licencee" in Rule 3(j).
The definition of Certificate of Registration in Rule 3(ya).
The new laboratory testing fees under Rule 19(3) and Rule 69.
The Ninth Schedule itself.

However, the proviso printed immediately after amending Rule 5 (the Rule 44(o) substitution) creates an explicit statutory exception:

"Provided, the compliance with clause (p) shall be mandatory with effect from six months from the date of this notification."

The Statutory Trigger: Notification Date vs. Publication Date

In Indian statutory drafting, the "date of notification" is the date on which the Central Government makes the order, whereas the "date of publication" is when it is printed in the Official Gazette:

Date of notification: 14 August 2026 (signed by Harsh Mangla, Joint Secretary).
Date of gazette publication: 19 August 2026.

Because the proviso explicitly states "six months from the date of this notification", the legal clock started on 14 August 2026. Exactly six calendar months from August 14, 2026 brings the mandatory compliance deadline to 14 February 2027.

Milestone Point	Date	What Operates
Notification Signed	14 August 2026	MoHFW issues notification; 6-month statutory transition clock commences
Gazette Published	19 August 2026	G.S.R. 743(E) legally in force; Ninth Schedule fees effective immediately
Transition Window	19 Aug 2026 – 13 Feb 2027	Voluntary adoption; "should" language; existing inventory release lawful
Mandatory Deadline	14 February 2027	Clause (p) becomes strictly mandatory ("shall be mandatory"); full enforcement

The Legal Implication of "Should" vs. "Shall Be Mandatory"

Drafting analysts will notice that the operative sentence of Rule 44(p) uses permissive language:

"...the license number of the sterilization site should be mentioned on label of the device."

However, the appended proviso eliminates any discretionary interpretation:

"...compliance with clause (p) shall be mandatory with effect from six months from the date of this notification."

Between 19 August 2026 and 13 February 2027, printing the contract sterilization site's licence number is legally recommended ("should"), allowing manufacturers to exhaust existing packaging inventories, modify artwork, and qualify revised labeling. Beginning 14 February 2027, compliance becomes strictly mandatory ("shall be mandatory"). Sterile devices released for sale or imported into India after this date without the prescribed prefix and licence number risk being categorized as misbranded medical devices under Section 18 of the Drugs and Cosmetics Act, 1940.

Did the Gazette Repeal Loan Licences, or Did PIB Say That on 24 August 2026?

The most dangerous compliance trap emerging from the August 2026 amendments is the belief that loan licences for outsourced sterilization have been repealed.

What the Press Information Bureau Claimed

On 24 August 2026, the Press Information Bureau (PIB) in New Delhi released statement PRID 2302665, titled:

"Union Ministry of Health and Family Welfare Proposes Amendments to Medical Devices Rules, 2017 to Promote Ease of Doing Business."

In that release, the ministry stated:

"Under the amended provisions, manufacturers outsourcing product sterilization to another facility holding a valid licence under the Medical Devices Rules, 2017 will no longer be required to obtain a separate loan licence for the outsourced sterilization activity."

The same PIB item also says the amendment "eliminates the requirement for a separate loan licensing process in such cases" and that "the amended provision also provides a six-month transition period for implementation of the new labelling requirement." The headline still uses "Proposes" / "Proposed amendments." PIB links only the G.S.R. 743(E) PDF (https://egazette.gov.in/WriteReadData/2026/275637.pdf) even though the same release also describes the Rule 63 European Union change, which lives in G.S.R. 744(E).

What G.S.R. 743(E) Actually Enacted

A rigorous examination of the authentic gazette text of G.S.R. 743(E) (CG-DL-E-21082026-275637) reveals a stark legal reality:

Statutory Dimension	Status in Gazette Text [G.S.R. 743(E)]	Status in Press Release [PIB PRID 2302665]
Rule 25 (Loan Licences)	Unchanged. Retains full statutory force.	Suggests loan licences will no longer be required.
Form MD-4 (Class A/B Loan Application)	Unchanged. Retains full statutory force.	Not mentioned specifically.
Form MD-6 (Class A/B Loan Licence)	Unchanged. Retains full statutory force.	Not mentioned specifically.
Form MD-8 (Class C/D Loan Application)	Unchanged. Retains full statutory force.	Not mentioned specifically.
Form MD-10 (Class C/D Loan Licence)	Unchanged. Retains full statutory force.	Not mentioned specifically.
Legal Status	Binding statutory law. Enforceable in court.	Ministry press release. Non-binding policy guidance.

Rule 25 remains fully intact: Chapter IV, Rule 25 of MDR-2017 governs loan licences for manufacturing Class A, Class B, Class C, and Class D devices. G.S.R. 743(E) does not amend, omit, or substitute Rule 25.
Statutory loan licence forms remain in the Second Schedule:
- Form MD-4: Application for grant of loan licence to manufacture for sale or distribution of Class A or Class B medical devices.
- Form MD-6: Loan licence to manufacture for sale or distribution of Class A or Class B medical devices.
- Form MD-8: Application for grant of loan licence to manufacture for sale or distribution of Class C or Class D medical devices.
- Form MD-10: Loan licence to manufacture for sale or distribution of Class C or Class D medical devices.
None of these forms or application provisions were deleted by G.S.R. 743(E).

The Regulatory Risk: State Licensing Authorities (SLAs)

In India, manufacturing licences (including loan licences) for Class A and Class B devices are issued and enforced by State Licensing Authorities (SLAs), while Central Licensing Authorities (CLA / CDSCO) oversee Class C and Class D devices.

State drug inspectors and SLAs enforce the text of the Official Gazette, not PIB press releases. If a domestic manufacturer surrenders or cancels its Form MD-6 or MD-10 loan licence on the assumption that PIB "ended loan licensing," but the inspector finds off-site sterilization without an active loan licence or an explicit CDSCO circular, the manufacturer can face enforcement for unauthorized contract manufacturing under Rule 20 and Rule 25.

Actionable Advice: Treat the PIB release as an indication of the ministry's long-term policy intent. Until CDSCO issues an official operational circular, guidance document, or further gazette notification amending Rule 25 and omitting Forms MD-4 and MD-8:

Do NOT cancel or surrender existing loan licences.
Continue to maintain robust quality agreements with contract sterilizers per sterilization supplier strategy principles.
Ensure that your contract sterilizer holds a valid, active manufacturing licence for sterilization under MDR-2017.

G.S.R. 744(E) Sibling Distinction: Why the EU Clinical Waiver Is a Different Instrument

On the exact same date that G.S.R. 743(E) was gazetted (19 August 2026), MoHFW published a companion statutory instrument: G.S.R. 744(E), titled the Medical Devices (Third Amendment) Rules, 2026 (Extraordinary No. 678; CG-DL-E-21082026-275639; F. No. X.11035/112/2024-DR).

Because both rules were notified on 14 August 2026, published on 19 August 2026, and shared the same ministerial file number, many industry summaries conflate their provisions. Regulatory teams must keep them strictly separated:

Dimension	G.S.R. 743(E) (Second Amendment)	G.S.R. 744(E) (Third Amendment)
Official Title	Medical Devices (Second Amendment) Rules, 2026	Medical Devices (Third Amendment) Rules, 2026
Gazette Reference	No. 677 (CG-DL-E-21082026-275637)	No. 678 (CG-DL-E-21082026-275639)
Primary Scope	• Outsourced sterilization labeling (Rule 44(p)) • 14 February 2027 compliance clock • Ninth Schedule laboratory test fees • Certificate of Registration definition	• Clinical investigation waiver expansion (Rule 63) • Class A NSNM self-certification standards (Rules 19H & 19J) • Retitling Rule 19 testing laboratories
Key Operational Amendment	Inserts Rule 44(p) prefixes: `Sterilization sites Manufacturing License Number`, `Ster. Mfg. Lic. No.`, `S.M. L.`	Inserts `"or European Union countries"` after `"or Japan"` in Rule 63(1) Proviso (iv)
Application to Sterilization	Direct: outsourced-sterilization artwork under Rule 44(p), mandatory from 14 February 2027.	None. Do not file a Rule 44(p) label change as a CE-mark waiver.

Does G.S.R. 744(E) Grant an Automatic CE-Mark Clinical Waiver?

A secondary myth circulating in the market is that G.S.R. 744(E) allows any CE-marked sterile device to bypass Indian clinical data requirements.

Under Rule 63(1) of MDR-2017, devices without a predicate in India require local clinical investigation unless the Central Licensing Authority abbreviates, defers, or waives that requirement. PIB PRID 2302665 describes the jurisdictions already recognised for that waiver as the United States of America, the United Kingdom, Australia, Canada, and Japan. G.S.R. 744(E) inserts "or European Union countries" after "or Japan" in Proviso (iv).

However, this is not an automatic exemption:

The device must still meet the other statutory conditions of Rule 63(1). Adding EU countries does not, by itself, waive Indian clinical investigation for every CE-marked device.
A non-predicate medical device still proceeds through Form MD-26 (application) and Form MD-27 (permission); a new IVD uses Form MD-28 / Form MD-29. Clinical investigation itself, when required, remains Form MD-22 / Form MD-23.
It has no bearing on Rule 44(p) labeling or Ninth Schedule laboratory test fees.

What Fails If You Make These Common Compliance Mistakes?

Regulatory inspections by CDSCO port drug controllers and state licensing authorities follow rigorous, text-based checklists. The following table identifies high-risk failure modes, their operational triggers, and how to avoid them:

Failure mode	Operational trigger	Regulatory consequence	Mitigation strategy
Inventing an unauthorized prefix	Printing `Mfg. Lic. No.` or `Sterilizer Lic:` instead of the three statutory prefixes.	Port drug controllers or SLAs can treat the label as not matching Rule 44(p); a shipment can be detained pending correction. The Drugs and Cosmetics Act, 1940, treats misbranded drugs (Section 17) as prohibited for manufacture and sale (Section 18); medical devices are regulated as drugs. That is a risk, not a guaranteed seizure.	Restrict artwork templates strictly to `Sterilization sites Manufacturing License Number`, `Ster. Mfg. Lic. No.`, or `S.M. L.`.
Collapsing compact prefix spacing	Printing `S.M.L.` without the space between `S.M.` and `L.`.	Technical non-compliance during SLA inspections or CDSCO post-market surveillance.	Update typography specifications to ensure a full standard space: `S.M. L.`.
Premature loan licence cancellation	Cancelling Form MD-6 or Form MD-10 on the strength of PIB PRID 2302665.	SLA citations for unlicensed contract manufacturing if Rule 25 is still being enforced; disruption of commercial distribution.	Maintain existing loan licences until CDSCO issues an explicit notification or circular amending Rule 25.
Applying Rule 44(p) to in-house sterilization	Adding an artificial sterilization licence number to products sterilized at the manufacturer's own licensed site.	Label confusion; unnecessary regulatory audit queries; wasted artwork expense.	Apply Rule 44(p) only where sterilization is outsourced to another facility that has a valid licence to carry out sterilization of medical devices.
Treating Ninth Schedule fees as licence tariffs	Budgeting Ninth Schedule amounts as CDSCO registration or Form MD-14 import licence fees.	Severe budget misallocations; regulatory filing delays due to unpaid Second Schedule fees.	Maintain Second Schedule statutory licence fees and Ninth Schedule testing fees on separate accounting lines.
Treating 19 August 2026 as the mandatory cutoff	Scrapping valid inventory in September 2026 due to lack of the new sterilization prefix.	Unnecessary write-offs of sterile finished goods.	Leverage the statutory transition window: existing labels remain compliant through 13 February 2027.

The Ninth Schedule: Comprehensive Laboratory Test Fee Structure

Amending Rule 6 of G.S.R. 743(E) inserts the Ninth Schedule into MDR-2017 after the Eighth Schedule. Amending Rule 7 then inserts Rule 19(3), and amending Rule 8 amends Rule 69, so government test-or-evaluation fees, including Form MD-33 applications, point at that Schedule.

When Do Ninth Schedule Fees Apply?

Ninth Schedule fees are not standard premarket application tariffs. They attach under two specific operational pathways:

Government laboratory testing under Rule 19: When CDSCO or a State Licensing Authority refers device samples (either during premarket evaluation, post-market surveillance, or formal investigation) to a government medical device testing laboratory.
Form MD-33 testing applications under Rule 69: When a manufacturer, importer, or regulatory applicant formally submits a device sample to a government testing laboratory for testing or evaluation under Form MD-33.

The Complete Statutory Fee Table

The following INR amounts are printed in G.S.R. 743(E). They are official gazette laboratory fees, not a MedDeviceGuide recompute. Scope notes in the last column are reader orientation, not additional legal tests.

Serial No.	Type of test or evaluation (gazette wording)	Statutory fee (INR)	Reader orientation (not gazette)
1	Implantation test	₹5,000	Biological / implantation evaluation
2	Sterility test	₹2,000	Sterility verification
3	Surgical Dressings	₹1,000	Surgical-dressing evaluation
4	Syringes & needles	₹1,000	Syringe and needle evaluation
5	Physical test / Physiochemical test for perfusion sets etc.	₹2,000	Perfusion-set physical / physicochemical evaluation
6	Surgical Sutures	₹3,000	Suture evaluation
7	Optical Rotation, Specific Gravity, Refractive Index, weight per ml, Fluorescence etc.	₹250 each	Listed physicochemical parameters, charged per parameter
8	Absorbency, Weight per unit area (Surgical), Foreign matter, Extractive value, Threads count, Length & Width (Surgical), Surface active substances, Acidity or alkalinity, Neps, Setting time etc.	₹150 each	Listed surgical-textile parameters, charged per parameter
9	Condoms	₹2,500	Mechanical contraceptive evaluation
10	Intrauterine Devices	₹2,500	IUD evaluation
11(a)	Bacterial endotoxin test — Qualitative	₹3,000	Qualitative BET
11(b)	Bacterial endotoxin test — Quantitative	₹4,500	Quantitative BET

Statutory Fee Notes and Rules

The Ninth Schedule includes two printed notes:

1. For test/evaluations not specified in the above table, charges shall be determined by the Director or Medical Device Testing Officer of the Laboratory/Institute as the case may be.

If a needed test is not in rows 1–11, do not invent a rupee figure. The laboratory Director or Medical Device Testing Officer quotes the charge.

2. The prescribed cost of the test/analysis shall automatically increase by 5% annually.

The gazette does not print the anniversary date (financial-year start versus gazette anniversary). Do not present a MedDeviceGuide recompute of a missing base date. Until CDSCO clarifies the anniversary, budget a 5 percent uplift as a 2027 planning assumption, then confirm the challan.

Fee Comparison: Ninth Schedule vs. Other Regulatory Costs

To ensure proper corporate budgeting, regulatory affairs and finance departments must distinguish Ninth Schedule laboratory fees from other Indian regulatory expenditures. Import-licence site and per-device amounts below are the Second Schedule rows independently extracted for the CDSCO MDSW 2026 operating guide from G.S.R. 78(E); confirm the current portal challan before paying.

Cost item	Statutory / contractual basis	Fee amount / basis	Payable to
Import, Class A other than IVD	Second Schedule, MDR-2017 (Form MD-14)	USD 1,000 per manufacturing site + USD 50 per distinct device	Central Licensing Authority
Import, Class B other than IVD	Second Schedule, MDR-2017 (Form MD-14)	USD 2,000 per manufacturing site + USD 1,000 per distinct device	Central Licensing Authority
Import, Class C or D other than IVD	Second Schedule, MDR-2017 (Form MD-14)	USD 3,000 per manufacturing site + USD 1,500 per distinct device	Central Licensing Authority
Government lab testing	Ninth Schedule, G.S.R. 743(E); Rules 19(3) and 69	₹150 to ₹5,000 per listed test, plus 5% annual increase; unlisted tests quoted by the Director or MDTO	Government medical device testing laboratory / Form MD-33
BIS certification (Scheme X)	BIS Conformity Assessment Regulations, 2018	Application fees, marking fees, factory audit costs — not Ninth Schedule rupees	Bureau of Indian Standards
Authorized Indian Agent (AIA)	Commercial contract	Retainer and dossier management fees	Commercial regulatory partner / AIA
Label packaging redesign	Internal QMS / supplier	Packaging engineering, film masters, plate tooling	Commercial packaging vendors

For a comprehensive review of BIS certification costs and standards overlap, refer to MedDeviceGuide's detailed India BIS certification guide.

G.S.R. 743(E) 30/60/90-Day SKU Map, Artwork, and Form MD-33 Fee Plan

To achieve seamless compliance before the 14 February 2027 deadline without risking customs impoundment or commercial supply disruptions, manufacturers should execute the following phased roadmap:

Phase 1: Days 1–30 (September 2026) — SKU Audit and Sterilizer Licence Verification

Audit product portfolio: Identify every medical device SKU currently registered (or in registration) for distribution in India that is supplied sterile.
Categorize sterilization processing:
- Group A (In-House): Devices sterilized within the legal manufacturer's own licensed establishment. Formally document that Rule 44(p) does not apply.
- Group B (Outsourced): Devices shipped to a third-party sterilization contractor (e.g., contract gamma irradiation, ethylene oxide, or electron-beam facility).
Collect contract sterilizer credentials: Request a current copy of the contract sterilizer's valid manufacturing licence under MDR-2017. Verify the exact licence number, facility address, and validity dates. Rule 44(p) requires "another facility having valid license to carry out sterilization process of medical devices." For imported SKUs sterilized outside India, the English gazette text does not say a US FDA establishment number, a 510(k) number, or a CE certificate substitutes for that licence. Confirm with your Authorized Indian Agent and CDSCO how the overseas site's number should appear before reserving artwork.
Review quality agreements: Confirm that existing vendor quality agreements mandate immediate notification if the contract sterilizer's licence is suspended, modified, or renewed. See MedDeviceGuide's guidance on quality agreements for sterilization vendors.

Phase 2: Days 31–60 (October 2026) — Prefix Selection and Artwork Routing

Select statutory prefix by package format:
- Use Ster. Mfg. Lic. No. as the standard default across primary cartons and pouches.
- Use S.M. L. for small-surface containers (ampoules, vials, small pouches).
- Use Sterilization sites Manufacturing License Number on shipping shippers and large kits.
Route engineering change orders (ECOs): Initiate formal labeling change control orders through your Quality Management System (QMS). Update packaging drawings, labeling bills of materials (BOM), and digital artwork files.
Maintain loan licensing: Ensure your Indian regulatory affiliate or Authorized Indian Agent (AIA) does not initiate loan licence cancellations based on PIB press releases.

Phase 3: Days 61–90 (November 2026) — Supplier Validation and Fee Budgeting

Validate print assets: Inspect supplier proofs to verify typography, character spacing (especially in S.M. L.), and legibility.
Budget Ninth Schedule testing: For any pending or planned Form MD-33 submissions, align purchase orders and accounting reserves to the Ninth Schedule fee schedule (e.g., ₹2,000 for sterility; ₹3,000–₹4,500 for BET).
Coordinate with foreign contract sterilizers: If manufacturing outside India for import under Form MD-14/MD-15, do not invent a foreign-licence substitute. Confirm with CDSCO or your AIA whether Rule 44(p) applies to that SKU and which number, if any, belongs on the Indian label.

Phase 4: Days 91–165 (December 2026 to 14 February 2027) — Cutover and Release

Inventory run-out: Deplete legacy packaging stock for batches scheduled for packaging before February 2027.
Cutover date: Mandate that all production lots packaged on or after 14 February 2027 carry the new Rule 44(p) labeling.
Verify import clearance documentation: Brief your Authorized Indian Agent and customs clearing agents with a regulatory briefing pack containing G.S.R. 743(E) to prevent improper customs queries during the transition window.

Frequently Asked Questions

Do we have to print the contract sterilizer's licence number on every India label before 14 February 2027?

No. While G.S.R. 743(E) was published in the Official Gazette on 19 August 2026, the proviso after amending Rule 5 states that compliance with clause (p) shall be mandatory with effect from six months from the date of this notification (14 August 2026). Mandatory enforcement begins on 14 February 2027. Prior to that date, legacy labeling remains legally acceptable, though manufacturers are encouraged to adopt the revised artwork as soon as feasible.

If we sterilize in-house at our own licensed manufacturing site, does Rule 44(p) still apply?

No. The statutory text of Rule 44(p) specifically applies: "In case of medical device manufacturer who outsourced the sterilization activity at the site of another facility having valid license to carry out sterilization process of medical devices..." If your facility performs sterilization on-site under its own manufacturing licence, you only print your own primary manufacturing licence number (for example Form MD-5, MD-7, or MD-9) as required by Rule 44(m). You do not invent a secondary sterilization licence number.

Did G.S.R. 743(E) cancel Form MD-4 and Form MD-8 loan licences for outsourced sterilization?

No. Although PIB statement PRID 2302665 of 24 August 2026 suggested loan licences would no longer be needed, the legal text of G.S.R. 743(E) does not amend Rule 25 or repeal Forms MD-4, MD-6, MD-8, or MD-10. Until CDSCO or MoHFW issues a further official gazette notification or formal regulatory circular amending Rule 25, State Licensing Authorities may still require active loan licences for domestic outsourced processing. Do not cancel existing loan licences solely on the basis of a press release.

Is the Ninth Schedule a new CDSCO registration or import-licence tariff?

No. The Ninth Schedule covers fees for government medical device testing laboratories under Rule 19 and Form MD-33 applications under Rule 69. It establishes fees for specific laboratory evaluations (such as ₹2,000 for sterility testing and ₹5,000 for implantation tests). It does not replace or alter the premarket registration and import licence fees set out in the Second Schedule of MDR-2017.

What is the difference between G.S.R. 743(E) and G.S.R. 744(E)?

Both were notified on 14 August 2026 and gazetted on 19 August 2026. G.S.R. 743(E) (Second Amendment) addresses outsourced sterilization labeling (Rule 44(p)), the 14 February 2027 clock, Ninth Schedule laboratory fees, and the Certificate of Registration definition. G.S.R. 744(E) (Third Amendment) addresses the expansion of recognized countries for clinical investigation waivers under Rule 63 (adding EU countries) and quality management system language for Class A non-sterile non-measuring self-certification under Rules 19H and 19J.

Can a CE-marked device skip Indian clinical investigation because of these August 2026 amendments?

No. The addition of European Union countries to Rule 63(1) Proviso (iv) by G.S.R. 744(E) lets the Central Licensing Authority consider a waiver for devices without a predicate. It is not an automatic CE-mark passport. Non-predicate devices still use Form MD-26 / MD-27; new IVDs use Form MD-28 / MD-29. This provision is part of G.S.R. 744(E), not G.S.R. 743(E).

How Pure Global Supports Indian Medical Device Regulatory and Labeling Compliance

Executing compliance across India's rapidly evolving medical device regulations requires integrated regulatory strategy, labeling engineering, and in-country authorized representation.

Pure Global provides complete regulatory affairs, authorized representation, and market-access management for medical device and IVD manufacturers entering or operating in India.

Indian Market Access and CDSCO Licensing: Complete management of Class A, B, C, and D registration dossiers, Form MD-14 import licence submissions, and SUGAM/MD-Online portal administration through our dedicated India regulatory practice.
Rule 44(p) Labeling Compliance Audits: Detailed review of packaging artwork, prefix selection, barcode/UDI alignment, and supply-chain verification for outsourced sterilization workflows ahead of the 14 February 2027 statutory deadline.
Authorized Indian Agent (AIA) Services: Full-scope in-country representation acting as your official regulatory liaison to CDSCO, state licensing authorities, and port drug controllers.
Contract Sterilization & Quality System Engineering: Vendor audit support, quality agreement drafting, and compliance alignment across ISO 11135 ethylene oxide and ISO 17665 steam sterilization standards.

To audit your Indian labeling portfolio or prepare for the 14 February 2027 transition, contact Pure Global's regulatory team.

Pure Global provides independent regulatory affairs, quality systems, and market-access advisory services. Pure Global is not the Central Drugs Standard Control Organisation (CDSCO), the Drugs Controller General of India (DCGI), a State Licensing Authority (SLA), or a Medical Device Notified Body.

Sources and Regulatory References

Medical Devices (Second Amendment) Rules, 2026 — G.S.R. 743(E) — Gazette of India Extraordinary, Part II, Section 3, Sub-section (i), No. 677 (CG-DL-E-21082026-275637), Ministry of Health and Family Welfare, notified 14 August 2026, published 19 August 2026.
Medical Devices (Third Amendment) Rules, 2026 — G.S.R. 744(E) — Gazette of India Extraordinary, Part II, Section 3, Sub-section (i), No. 678 (CG-DL-E-21082026-275639), Ministry of Health and Family Welfare, notified 14 August 2026, published 19 August 2026.
Union Ministry of Health and Family Welfare Proposes Amendments to Medical Devices Rules, 2017 to Promote Ease of Doing Business — Press Information Bureau, Government of India (PRID 2302665, 24 August 2026).
Draft Medical Devices (Amendment) Rules, 2026 — G.S.R. 270(E) — Ministry of Health and Family Welfare, dated 10 April 2026.
CDSCO Medical Devices & Diagnostics Division — Central Drugs Standard Control Organisation, Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India.
Medical Devices Rules, 2017 (G.S.R. 78(E)) — Ministry of Health and Family Welfare, Government of India, effective 1 January 2018 (including subsequent amendments through G.S.R. 743(E) and G.S.R. 744(E)).
Drugs and Cosmetics Act, 1940 — Act No. 23 of 1940, Government of India.
India CDSCO Medical Device Registration Guide.
India CDSCO Medical Device Software (MDSW) Guidance 2026.
India Medical Device Market & Approved Devices Analysis 2026.
Sterilization Supplier Strategy & Capacity Risk Guide.
ISO 17665 Steam Sterilization Standard Guide.
Ethylene Oxide Sterilization Guide.
India BIS Certification Medical Devices Guide.