Health Ministry Proposes Mandatory Disclosure of Sterilisation Site Licence on Device Labels
New Delhi: In order to streamline regulatory provisions and strengthen compliance requirements in the medical devices sector, the Ministry of Health and Family Welfare has issued a draft notification proposing amendments to the Medical Devices Rules, 2017, inviting objections and suggestions from stakeholders within 30 days of publication.
The draft rules, published after consultation with the Drugs Technical Advisory Board, propose to formally introduce the definition of a “Certificate of Registration,” to be granted by State or Central Licensing Authorities in specified forms. The amendments also remove certain redundant wording in existing provisions to improve clarity in regulatory interpretation.
A key change relates to labeling requirements. In cases where medical device manufacturers outsource sterilization to licensed third-party facilities, the draft mandates that the license number of the sterilization site must be clearly mentioned on the product label, using specified formats such as “Sterilization sites Manufacturing License Number” or abbreviated versions.
Further, the draft introduces a new Ninth Schedule under the rules, detailing fees for various tests and evaluations of medical devices. These include charges for implantation tests, sterility tests, surgical dressings, sutures, condoms, intrauterine devices, and bacterial endotoxin testing, among others. The schedule also provides that fees for unspecified tests will be determined by the concerned laboratory authority and that all testing charges will automatically increase by 5% annually.
Additionally, amendments have been proposed to link testing fees explicitly with regulatory procedures. A new sub-rule under Rule 19 specifies that fees for testing and evaluation will be as per the Ninth Schedule, while Rule 69 is proposed to be modified to require applications to be accompanied by the prescribed fee.
The government stated that the draft rules will be finalized after considering stakeholder feedback, marking another step toward enhancing regulatory transparency and standardization in India’s medical devices framework.
The notice stated,
"1. (i) These rules may be called the Medical Devices (.........Amendment) Rules, 2026.
(ii) These rules unless specified otherwise, come into force on the date of their final publication in the Official Gazette.
2. In the said rules, in clause (j) of rule 3, the word “of a licencee” shall be omitted.
3. In the said rules, after the clause (y)of rule 3, the following clause shall be inserted. (ya) “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;
4. In the said rules, after clause (o) of Rule 44, the following clause shall be inserted. (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”;
5. In the said rules, in the clause (o) of Rule 44, after the words “and (m)”, shall be substituted by the words, “(m) and (p)”.
6. In the Medical Devices Rules, 2017, (hereinafter referred to as the said rules), after Eighth Schedule, the Ninth Schedule shall be inserted namely: -
Ninth Schedule
“Fee for test or evaluation
[See rules 19, 69]
Sr. No. | Type of Test / Evaluation | Cost (INR) |
(1) | (2) | (3) |
1 | Implantation test | 5000 |
2 | Sterility test | 2000 |
3 | Surgical dressings | 1000 |
4 | Syringes & needles | 1000 |
5 | Physical / Physicochemical test (perfusion sets etc.) | 2000 |
6 | Surgical sutures | 3000 |
7 | Optical rotation, specific gravity, refractive index, weight per 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 | 2500 |
10 | Intrauterine devices | 2500 |
11 (a) | Bacterial endotoxin test (Qualitative) | 3000 |
11 (b) | Bacterial endotoxin test (Quantitative) | 4500 |
Note: -
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.
2. The prescribed cost of the test/analysis shall automatically increase by 5% annually.
7. In the said rules, in Chapter III, in rule 19, after sub-rule (2), the following sub-rule shall be inserted namely: -
“(3) The fees for test or evaluation shall be those specified in ninth Schedule.”
8. In the said rules, in Chapter IX, in rule 69, after the words “in Form MD-33”, the words “accompanied with a fee specified in the Ninth Schedule” shall be inserted."
To view the notice, click the link below:
