Last Updated on August 24, 2026 by The Health Master
Medical Devices
The Ministry of Health and Family Welfare has issued G.S.R. 743(E) dated 14-08-2026 under the Drugs and Cosmetics Act that enacts the Medical Devices (Second Amendment) Rules, 2026.
Download Notification: GSR 743(E) dt 14-08-2026 Definition of Registration Certificate, Sterilization Site Labeling Requirement, New Testing & Evaluation Fee Structure
The draft rules for Medical Devices were published earlier in April 2026 under G.S.R. 270(E).
The final rules published under G.S.R. 743(E) include changes to the definition of a manufacturing license for medical devices, the definition of a registration certificate for medical devices, the rules regarding the sterilization and labeling of medical devices manufactured outside of India, and the fees to be paid to Indian and international laboratories for the testing of medical devices.
Medical Devices (Second Amendment) Rules, 2026: Key Highlights
G.S.R. 743(E) was dated August 14, 2026. The rules will come into immediate effect upon publication in the Gazette of India on August 19, 2026.
Additionally, the rules will provide a 6-month period for medical device manufacturers to comply with the new rules regarding the labeling of sterilized medical devices.
The rules will be governed by the Central Drugs Standard Control Organisation (CDSCO), the Ministry of Health and Family Welfare.
The rules will impact medical device manufacturers, importers of medical devices, notified bodies, medical device testing laboratories, and those who provide medical device regulatory consulting services to manufacturers and importers.
Clarifying the Scope: Definition of “Certificate of Registration”
The amendment to Rule 3 of the Medical Devices Rules, 2017 serves to eliminate ambiguities regarding the type of registrations that are granted to licensees by the State Licensing Authorities (SLA) and the Central Licensing Authorities (CLA):
- Rule 3(j) has been amended by the deletion of the phrase “of a licencee”;
- Rule 3(ya) has been added to define the term “Certificate of Registration”. Such a Certificate of Registration shall be the certificate of registration issued in Form MD-2, Form MD-40 or Form MD-42 by the licensing authority.
Mandatory Outsourced Sterilization Site Labeling (Rule 44)
Maintaining traceability of devices in the case where they are manufactured at an outsourced manufacturing site is of high priority for the regulatory authorities.
The amendment to Rule 44 incorporates sub-clause (p) that addresses the labeling of devices manufactured at an outsourced manufacturing site when the sterilization of such devices is performed at a site that is contracted out to a third party:
The requirement for outsourcing of the sterilization process to third parties with a license for sterilization requires the inclusion of the license number of the site where the device was sterilized on the product label.
The license number must be preceded by one of the following terms:
- Sterilization sites Manufacturing License Number
- Mfg. Lic. No.
- S.M.L.
Manufacturers will be provided with the necessary six months to update the labels and packaging lines for the products.
Introduction of the Ninth Schedule: Standardized Testing & Evaluation Fee Structure
To streamline government laboratory testing charges and third-party sample evaluations, the amendment introduces the Ninth Schedule, which can be accessed via amended Rule 19(3) and Rule 69 of Form MD-33.
| Sr. No. | Type of Test / Evaluation | Prescribed Fee (INR) |
| 1 | Implantation test | ₹5,000 |
| 2 | Sterility test | ₹2,000 |
| 3 | Surgical Dressings evaluation | ₹1,000 |
| 4 | Syringes & needles testing | ₹1,000 |
| 5 | Physical / Physiochemical test for perfusion sets, etc. | ₹2,000 |
| 6 | Surgical Sutures testing | ₹3,000 |
| 7 | Optical Rotation, Specific Gravity, Refractive Index, Weight/ml, Fluorescence, etc. | ₹250 each |
| 8 | Absorbency, Weight per unit area, Foreign matter, Extractive value, Thread count, Length & Width, Surface active substances, Acidity/alkalinity, Neps, Setting time, etc. | ₹150 each |
| 9 | Condoms testing | ₹2,500 |
| 10 | Intrauterine Devices (IUD) testing | ₹2,500 |
| 11 (a) | Bacterial Endotoxin Test (BET) – Qualitative | ₹3,000 |
| 11 (b) | Bacterial Endotoxin Test (BET) – Quantitative | ₹4,500 |
Statutory Notes on Lab Testing Charges:
The charges for tests that are not mentioned in the schedule will be set on a case-by-case basis by the Director or the Medical Device Testing Officer (MDTO) of the testing laboratory.
The fees will automatically increase by 5% every year as per the schedule.
Practical Steps for Medical Device Manufacturers:
Ensure that any third-party facility performing sterilization of the medical devices has its details added to the artwork and packaging within the 6-month period.
Include the details of the charges laid out in the Ninth Schedule in the cost estimates submitted in Form MD-33.
Ensure that the license of the company that is performing the sterilization is active and up to date.
Additional information for Medical Devices
For additional information for Medical Devices, click below:
Medical Devices Rule 2017
To download Medical Devices Rule 2017, click below
Registration and labelling requirements of Medical Devices
GCGI-dt-28-09-2021-Registration-and-labelling-requirements-of-Medical-Devices
Medical Device Alert, click the below link
Medical Device Notifications
For various notifications of medical devices, click the below link:
Notifications – Medical Devices
For informative videos on Medical Devices, click on the below YouTube icon:
