India Requires Outsourced Sterilisation Licence Number on Labels

India’s Ministry of Health and Family Welfare notified the Medical Devices (Second Amendment) Rules, 2026 as G.S.R. 743(E) on 14 August 2026. The Gazette of India Extraordinary published the English text on 19 August 2026 (Part II, Section 3, Sub-section (i), No. 677, CG-DL-E-21082026-275637).

Two clocks in the same instrument must be kept apart:

• Rule 1(ii): the rules come into force on the date of final publication in the Official Gazette unless specified otherwise. That general force date is 19 August 2026.
• The proviso after Rule 5: compliance with new Rule 44(p) “shall be mandatory with effect from six months from the date of this notification.” The notification is dated 14 August 2026. Six calendar months later is 14 February 2027 (Pure Global calculation from those two locators). The gazette date is not the starting point of that six-month period.

The draft was G.S.R. 270(E) of 10 April 2026. The same-day Third Amendment, G.S.R. 744(E), is a different notification.

Outsourced sterilisation on the label

New Rule 44(p) applies where a medical-device manufacturer outsourced the sterilisation activity at the site of another facility that has a valid licence to carry out sterilisation of medical devices. In that case, the licence number of the sterilisation site should be mentioned on the device label, preceded by one of:

• “Sterilization sites Manufacturing License Number”
• “Ster. Mfg. Lic. No.”
• “S.M. L.”

Those strings are quoted from the English gazette, including the American spelling and the spaces.

The clause uses “should.” The delayed-force proviso uses “shall be mandatory.” From 14 February 2027, clause (p) is obligatory.

Pure Global reading: the duty is conditioned on outsourcing to another licensed sterilisation site. The notification does not, on its face, require a second licence number for sterilisation carried out at the manufacturer’s own licensed manufacturing premises.

Rule 5 amends the small-device list in Rule 44(o). Before this notification, where information could not be printed legibly, the reduced set was clauses (a), (b), (c), (d), (e), (g), (k) and (m). The words “and (m)” are substituted by “(m) and (p).” Small labels must therefore also carry the sterilisation-site number when (p) applies.

Ninth Schedule test fees

From the general force date, a Ninth Schedule (“Fee for test or evaluation”, see Rules 19 and 69) is inserted after the Eighth Schedule. New Rule 19(3) says the fees for test or evaluation shall be those specified in that Schedule. Rule 69 now requires an application in Form MD-33 to be “accompanied with a fee specified in the Ninth Schedule.”

“Physiochemical” is the gazette spelling. Note 1: charges for tests not listed are determined by the Director or Medical Device Testing Officer of the laboratory or institute. Note 2: the prescribed cost “shall automatically increase by 5% annually.” The notification does not state which anniversary starts that increase.

Two definitional edits travel with the same gazette and are not the operational lead: Rule 3(j) omits “of a licencee” from the defined term, and new Rule 3(ya) defines “Certificate of Registration” as a registration certificate granted by the State or Central Licensing Authority in Form MD-2, Form MD-40, or Form MD-42, as the case may be. Those forms already existed (notified body, testing laboratory, and Class A NSNM registration). The definition does not, by itself, change how they are granted.

What manufacturers should do now

1. Inventory SKUs that use a contract sterilisation site and obtain that site’s current manufacturing licence number.
2. Reserve label space for one of the three prescribed prefixes plus the number, including on small-device labels that rely on Rule 44(o).
3. Treat 14 February 2027 as the mandatory date for clause (p), and 19 August 2026 as the date Ninth Schedule fees apply to Rule 19 / Rule 69 testing. Do not collapse those dates.
4. Do not assume in-house sterilisation at the licensed manufacturing site needs a second number unless a later instrument says so.
5. Budget Ninth Schedule fees as printed, including the unspecified 5% annual increase, and confirm unlisted tests with the testing laboratory.

The authentic English PDF is the Gazette file linked above. CDSCO’s Gazette Notifications index is the landing page. Indian market-access context is on Pure Global’s India page.