Draft Amendment to Medical Devices Rules, 2017 (G.S.R. 270(E), 2026)

Draft Medical Device Rules Introduce New Fees

Vincular
2 min read

The Ministry of Health & Family Welfare has proposed another draft amendment to the Medical Devices Rules, 2017, inviting stakeholder feedback.  Key Highlights  ▪️ New Definition Introduced “Certificate of Registration” has been clearly defined, covering registrations issued on Forms MD-2, MD-40, and MD-42.  ▪️ Labelling Requirement for Outsourced Sterilisation Manufacturers outsourcing sterilisation must now mention

The Ministry of Health & Family Welfare has proposed another draft amendment to the Medical Devices Rules, 2017, inviting stakeholder feedback. 

Key Highlights 

▪️ New Definition Introduced
“Certificate of Registration” has been clearly defined, covering registrations issued on Forms MD-2, MD-40, and MD-42. 

▪️ Labelling Requirement for Outsourced Sterilisation
Manufacturers outsourcing sterilisation must now mention the license number of the sterilisation facility on product labels, enhancing traceability and compliance.

▪️ Introduction of Ninth Schedule (Fees)
A new fee structure for testing and evaluation of medical devices has been introduced, covering tests like:

  • Implantation, sterility, sutures, syringes, condoms, etc.  
  • Additional tests charged individually  
  • Annual 5% increase in testing fees  

▪️ Fee-Linked Compliance
Testing and evaluation fees are now formally linked to Rule 19 and Rule 69, making fee payment mandatory for related approvals. 

▪️ Minor Definition & Rule Updates
Certain wording changes and insertions to improve clarity and regulatory structure. 

Public Consultation Open
Comments and suggestions can be submitted within 30 days of publication. 

Link to official notification :- Draft QCO_Medical Devices Amendment Rules, 2026.pdf 

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