India Regulatory Update​

December 2025

A draft amendment (notification dated 04-Dec-25) to the Medical Device Rules has now been issued by the Ministry of Health and Family welfare inviting comments from the industry within 30 days from the issue of this notice.

Broadly, the proposed amendments are the following:

  1. License/Registration certificate Validity: As already in practice it is clarified that the manufacturing and import licenses (Forms MD-5, MD-6, MD-9, MD-10, MD-15) and Registration Certificates (Form MD-40) will no longer expire. Thus, all licenses/registration certificates will henceforth contain the following statement:

“The licence /registration certificate shall remain valid in perpetuity, unless, it is suspended or cancelled or surrendered, provided that the licence holder deposits a licence retention fee as per the provisions of Medical Devices Rules, 2017”.

  1. Class A (Non-Sterile and Non-Measuring) : For such products, the terminology “Registration Number” or “Reg. No.”  has been introduced at various places in amendment and to be used on labels, Audit/Inspection book (format as per MD-11), import documents etc., so that it is distinct from the Import / Manufacturing License Numbers.
  2. New Form MD–44 introduced : for “Report of Test or Evaluation by registered Medical Device Testing Laboratory” to be used by Registration holders to submit test or evaluation reports.
  3. Forms MD-36/37/38 relating to sampling amended: Additional tables/details have now been included in these forms.
  4. In-Vitro Diagnostic: Fifth schedule applicability extended to all medical devices including IVD’s. Certain typos relating to IVD’s have been corrected for better clarity at various places in the MDR.

Objections and suggestions, if any, to the above amendments can be emailed at drugsdiv-mohfw@gov.in.

CDSCO has introduced a new risk-classification module on its online portal for medical devices (excluding in-vitro diagnostics). This feature enables applicants to submit risk-classification requests for devices that are not included in the currently published CDSCO risk-classification list.
Document- Check Here

November 2025

Further to the draft risk classification lists released in Jan 25 for Interventional Radiology & Radiotherapy medical devices, CDSCO has now issued the attached final classification lists for both.

Available here: Radiology & Radiotherapy medical devices

CDSCO had previously published a draft risk list of medical devices falling under Class A NSNM (non-sterile, non-measuring) on 06Jan25. Now, vide the attached office note (File No. MED-16014(12)/1/2024-eoffice-Part(2) dated 31Oct25) the final list of such medical devices falling under Class A NSNM has been released.

Document Risk based classification list of Class A(NSNM) MD 31Oct25
CDSCO has issued the attached circular dates 17-Nov-25 addressed to the procurement agencies of Institutes/Organisations/Hospitals requesting them to make medical devices license, issued by CDSCO /State/UT’s licensing authorities, mandatory as part of the requirements for the procurement of Medical Device. Without this license the medical device cannot be sold in the country. 
 
This has been issued since it has been brought to the notice of Ministry of Health & Family welfare that such procurement agencies are insisting for requirements of USFDA/CE certifications for procurement bids instead of Central/State Licensing authorities.

Document Procurement Agencies
Please be informed that CDSCO has now issued the attached Addendum (No. 3) to the Medical Devices FAQ’s. 

Document Addendum-03-to-FAQ-on-Medical-Devices-Rules-2017
FYI. Please find attached herewith circular dated 20-Nov-25 issued by CDSCO asking all State/Union territory Drug Licensing Authorities to ensure the display of the QR code (attached), of Adverse Drug Reaction Monitoring System (ADRMS), at prominent location within every retail & wholesale pharmacy premises across the country.
 

Additionally, the toll-free number of Pharmacovigilance Programme of India (PvPI)  i.e. 1800-180-3024- must also be clearly displayed with the QR Code at each pharmacy outlet  as per the format provided.

This is part of the ongoing commitment to strengthening patient safety and pharmacovigilance in the country.

Document ADR QR Code

The Department of Consumer Affairs’ Legal Metrology Division has issued a new set of Frequently Asked Questions (FAQs) providing key clarifications, see attached copy.

Document FAQ_1763035301

October 2025

The Ministry of Consumer Affairs, Food & Public Distribution has issued an amendment (vide attached notification dtd. 23 Oct 2025) specifically applicable to Medical Devices. The amendment allows, for specified clauses, the application of the provisions of the Medical Devices Rules, 2017 instead of the Legal Metrology Rules.

As a consequence of this, medical devices manufacturers are provided greater flexibility as follows:
 
  2. The size of letters and numerals on medical device labels should be clearly visible as per the Medical Devices Rules, 2017, rather than the specific criteria under Legal Metrology.
  3. Medical devices shall not be penalized for differences in label layout or size, provided the required information is correctly displayed.
    See Document-
     MDR Legal Metrology update important _23Oct25
CDSCO has now made available on its website the updated list of applicable BIS Standards corresponding to the various categories of medical devices at the following link- 
 
This would serve as a roadmap for manufacturers/importers, providing clear guidelines to align their products with the applicable quality and safety standards.
 
(At RSI we also provide services relating to BIS certifications, for more details do refer “The Role of BIS standards for Medical Devices“.)

CDSCO has now shared the attached draft notification regarding Debarment of applicant for submitting misleading, or fake, or fabricated documents, information.

If an applicant or their representative submits misleading, fake, or fabricated information, the Licensing Authority may, after giving an opportunity to explain, debar them for a period deemed fit. An aggrieved applicant may appeal to the Government within 30 days, which will review the case and issue an appropriate order after a hearing.

Please note, that the said draft rules shall be taken into consideration on or after the expiry of a period of thirty days from the date on which the copies of the Gazette of India containing these draft rules are made available to the public (i.e.,16.October.25). During this period objections and suggestions, if any, may be addressed to the Director (Drugs regulation), Ministry of Health and Family Welfare as per details provided in the draft notification.

See Document- 2025.10.16_ G.S.R. 756(E)_ Draft Notification

The circular states the amendments have been done basis the Industry associations suggestions for  simplification of disclosure.
 
Additionally the circular also clarifies that in case the company is not a member of any industry association then  the disclosure shall be made on the UCMPMD portal of the Department of Pharmaceuticals.
 
The portal for disclosure of marketing expenditure under UCPMP/UCMPMD is available at https://ucmp.pharma-dept.gov.in/.

See Document-Sep25_Ucmpmd circular with amended code_1_0

 

The Legal Metrology Division, Department of Consumer Affairs has now issued a draft amendment to the LMPC rules (vide attached notification dtd. 23-Oct-25) and invited stakeholder comments on the same till 22-Nov-25.
 

In addition to the E-commerce declarations already prescribed under LMPC rules vide notification dtd 23rd June 2017, the current notification proposes e-commerce entities selling imported products to include a searchable and sortable country-of-origin filter in their product listings.

See Document-  Draft_LMPC_Second_Amendment_Rules2025

CDSCO has now issued a draft Guidance Document on Medical Device Software  to bring more clarity on the regulatory aspects for Medical Device software. 

Comments are now invited (via the google form link provided in the guidance document) by the 20th of Nov 25 from stakeholders. As this foundational document for providing clarity on this important subject would request impacted stakeholders to review the same and provide their valuable feedback to CDSCO directly.

 

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