Endorsement of Predicate In Vitro Diagnostics in Manufacturing License (Form MD 5) in India - MD-3 & MD-5

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Are you a manufacturer of Class A or B notified medical devices in India, aiming for seamless market entry to distribute and sell your devices? CliniExperts is your one-stop solution for navigating the crucial Form MD-05 licensing process, efficiently and effectively.

Endorsement of Predicate In Vitro Diagnostics in Manufacturing License (Form MD 5) – Overview

Any person who have the manufacturing license of Class B IVD and intends to manufacture a Class A or Class B medical device shall make an application for grant of endorsement license to manufacture for sale or for distribution to the State Licensing Authority through identified online portal of the Ministry of Health and Family Welfare in the Central Government in Form MD-3 for obtaining the license in FORM MD-5.

Who Can Apply?

Application for endorsement is only available to manufacturers with the form MD 5 approval to manufacture the IVD.

Endorsement of Predicate In Vitro Diagnostics in Manufacturing License (Form MD 5)

How To Apply?

The Applicant must follow the following process:

To obtain an endorsement license to manufacture for sale and distribution of a Class A or Class B medical device, the manufacturer must submit Form MD-3 along with the required documents to the State Licensing Authority.

Cover letter
Constitution detail of the firm
Establishment/Site ownership/Tenancy Agreement
Copy of the duly notarized valid copies of the Quality Certificate of the manufacturing site
Performance Evaluation Report (IVDs only)
Device Master File
MD 5 license copy
Test License obtained for testing
Generation of quality control data
Undertaking signed stating that the manufacturing site complies with the provision of the Fifth schedule.

Validity

As long as the license is issued in Form MD-5, it remains valid for the duration of the license, provided that it is repaid within five years of its issue by paying the license retention fee as specified in the Second Schedule unless the license is revoked by the State Licensing Authority or suspended.

Fee Involved

There is a government fee of Rs. 500 for the application process of each distinct Medical Device of Class A or Class B.

Important Documents

During the documentation process, the following documents should be present:

Quality Management System (QMS) Documents
Device Master File

Timeline to get MD-5 from Central Drugs Standard Control Organisation

2-3

Months

Essential Tips

Expert Advise

According to the experts, the manufacturers should generate quality control data based on a valid test license at the time of application submission.

Frequently Asked Questions

Is it possible for the manufacturer to select the notified body?

In accordance with the State Licencing Authority's advice, the notified body accredited under sub-rule (1) of Rule 13 of the Medical Device Rules 2017 is authorised to conduct an audit of manufacturing sites for Class A and Class B medical devices to confirm compliance with the Quality Management System and other applicable standards as specified under these rules.

Does a manufacturing company still have to adhere to BIS standards if it is meeting ISO/IEC standards?

The medical device should follow the standards set by the Bureau of Indian Standards, which was established under section 3 of the Bureau of Indian Standards Act, 1985 (63 of 1985). Alternatively, the Ministry of Health and Family Welfare in the Central Government may notify changes to the standards from time to time. If no relevant standard has been set under sub-rule (1), the device should follow the standards set by the International Electrotechnical Commission (IEC), the International Organization for Standardisation (ISO), or any other pharmacopoeia standards. If the device does not meet the standards listed under sub-rules (1) and (2), it should follow the validated manufacturer's standard.

If devices that are currently on the market but have not been notified are added to the list of notified devices, would business continuity be taken into account?

The manufacturer of the device must abide by the Medical Device Rules 2017 when it falls within one of the notified categories.

Would there be an exemption to the need for a local clinical investigation and evaluation for devices that are currently on the market and were announced later?

The medical device will be evaluated on a case-by-case basis and in light of available data to verify its efficacy and safety. The SEC may also be asked to hear the case.