Proposed Amendments to Medical Device Rules, 2017

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Dated: 23.12.2025

Proposed Amendments to Medical Device Rules, 2017

The Ministry of Health and Family Welfare, Government of India, has recently published a draft notification (G.S.R. 883(E)) on December 4, 2025, proposing amendments to the Medical Device Rules, 2017. These amendments aim to streamline regulatory processes, enhance compliance, and ensure the quality and safety of medical devices in India. The draft rules are open for public consultation, and stakeholders are invited to submit their objections and suggestions within 30 days of the publication of the Gazette notification.

Key Highlights of the Proposed Amendments

1. Introduction of Registration Numbers for Class A Medical Devices 

The amendments propose the inclusion of “Registration number” or “Reg. No.” for Class A (Non-Sterile and Non-Measuring) medical devices in various clauses of rules 44 and 45. This change aims to simplify the identification and tracking of these devices, ensuring better regulatory oversight.

2. Changes to Chapter IX Heading 

The heading of Chapter IX in the Medical Device Rules, 2017, will be modified by omitting the words “AND NOTIFIED BODY.” This change reflects a shift in the regulatory framework for medical devices.

3. New Reporting Requirements for Registration Certificate Holders 

A new sub-rule (xi) is proposed under rule 85, mandating registration certificate holders to furnish reports of test or evaluation results of medical devices in the newly introduced Form MD-44. This form will include detailed information about the medical device, raw materials, components, and test results, ensuring transparency and accountability.

4. Perpetual Validity of Licences and Registration Certificates 

The amendments propose that registration certificates and licences will remain valid perpetually unless suspended, cancelled, or surrendered. However, holders must deposit a retention fee as per the provisions of the Medical Device Rules, 2017. This change is reflected in Forms MD-2, MD-5, MD-6, MD-9, MD-10, and MD-15.

5. Updates to Forms and Schedules

Several forms and schedules in the Medical Device Rules, 2017, are proposed to be updated. Key changes include:

Second Schedule: Substitution of Sr. No. 39(h) to specify one overseas site manufacturing Class C or Class D in vitro diagnostic medical devices.
Fifth Schedule: Applicability extended to manufacturers of medical devices, including in-vitro diagnostic medical devices.
Form MD-11: Updates to include “Registration holder” alongside “licensee” and modifications to the format for better clarity.
Forms MD-36, MD-37, and MD-38: Addition of detailed tables to capture comprehensive information about medical devices, including batch numbers, manufacturing details, and expiry dates.

6. Introduction of Form MD-44 

A new form, Form MD-44, has been introduced to standardize the reporting of test or evaluation results by registered medical device testing laboratories. This form includes detailed fields for capturing information about the medical device, raw materials, components, and test results. It also requires the person in charge of testing to provide their opinion on whether the device meets the standard quality as defined in the Drugs and Cosmetics Act, 1940, and Medical Device Rules, 2017.

Public Consultation Process

The Ministry has invited objections and suggestions from stakeholders, which can be submitted to the Under Secretary (Drugs), Ministry of Health and Family Welfare, Government of India, at Room No. 437, C Wing, Nirman Bhavan, New Delhi – 110011, or via email at drugsdiv-mohfw@gov.in. The feedback will be considered by the Central Government before finalizing the amendments.

Implications of the Amendments

The proposed changes to the Medical Device Rules, 2017, are expected to have significant implications for manufacturers, importers, and stakeholders in the medical device industry. Key benefits include:

Enhanced traceability and accountability through the introduction of registration numbers for Class A medical devices.
Simplified regulatory processes with perpetual validity of licences and registration certificates.
Improved quality assurance through mandatory reporting of test results in Form MD-44.
Greater clarity and standardization in documentation and compliance requirements.

Conclusion

The draft amendments to the Medical Device Rules, 2017, reflect the Government of India’s commitment to ensuring the safety, quality, and efficacy of medical devices in the country. By introducing new provisions and updating existing rules, the amendments aim to create a robust regulatory framework that supports innovation while safeguarding public health.

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Source: MoHFW

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