Legal Note on Draft Amendments to the Medical Devices Rules, 2017 (MDR 2017)

Legal Note on Draft Amendments to the Medical Devices Rules, 2017 (MDR 2017)

The Ministry of Health and Family Welfare (MoHFW) has issued a Draft Gazette Notification proposing multiple amendments to the Medical Devices Rules, 2017 (MDR 2017). The draft reflects the Government’s continued efforts to streamline regulatory processes under the Indian Medical Device Rules while strengthening compliance, transparency, and post-market oversight within the medical device sector.

These proposed changes mark a significant shift in medical device regulation in India, particularly with respect to license validity, testing requirements, and quality management obligations.

Key Legal Changes Proposed Under the Draft Notification

1. Introduction of Perpetual Validity for Licenses and Registration Certificates

A major reform under the proposed Medical Device Rules Amendment is the introduction of perpetual validity for certain licenses and registration certificates, subject to compliance with retention fee requirements.

Registration Certificates

• Form MD-2 (Notified Bodies under MDR 2017)

• Form MD-40 (Medical Device Testing Laboratories - MDTLs)

Registration certificates issued under these forms shall remain valid in perpetuity, unless suspended, cancelled, or surrendered, provided the registration retention fee is deposited in accordance with the Medical Devices Rules.

Manufacturing and Loan Licenses

• Form MD-5 and Form MD-6 (Class A and Class B devices)

• Form MD-9 and Form MD-10 (Class C and Class D devices)

Licenses to manufacture or loan licenses for the above classes will no longer require periodic renewal and will continue indefinitely, subject to payment of the medical device license retention fee and regulatory compliance.

Legal Impact:
This change significantly reduces administrative burden and enhances predictability for manufacturers holding a medical device manufacturing license in India.

2. Introduction of Form MD-44 for Testing and Evaluation Reports

A new Form MD-44 has been inserted as a standardized format for:

• Reporting test or evaluation results by a registered Medical Device Testing Laboratory (MDTL)

• Declaration of the quality and conformity of medical devices

3. Regulatory Clarity for Class A Non-Sterile and Non-Measuring Devices

The draft proposes the insertion of the term “registration number” for Class A (Non-Sterile and Non-Measuring) Medical Devices across relevant rules.

4. Amendment to Fee Structure for Overseas Manufacturers

Under the Second Schedule of MDR 2017, the fee provision for overseas manufacturing sites has been revised to specifically cover:

Overseas sites manufacturing Class C or Class D in-vitro diagnostic (IVD) medical devices

5. Expansion of Quality Management System (QMS) Applicability

The Fifth Schedule relating to Quality Management System (QMS) requirements has been revised to explicitly include in-vitro diagnostic devices.

Revised clause:

“The provisions of this Schedule shall be applicable to manufacturers of medical devices, including in-vitro diagnostic medical devices.”

6. Enhanced Transparency in Sampling and Seizure Provisions

Additional provisions have been introduced across multiple forms related to:

• Receipt of seized medical device samples

• Identification of the person from whom the sample is taken

• Detailed documentation during regulatory actions under the Drugs and Cosmetics Act

Regulatory Significance

The draft amendments represent a balanced regulatory approach simplifying licensing through perpetual validity, while reinforcing quality control, testing, and inspection mechanisms. Once finalized, these changes are expected to:

• Improve ease of doing business

• Enhance regulatory certainty

• Strengthen oversight under CDSCO medical devices regulation

Stakeholders are advised to review the draft carefully and participate in the public consultation process before final notification in the Gazette of India.

Click here to Access the official guidance document

Note:
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