Feb 18, 2022

Indian regulators have published draft rules for obtaining registration certificates required to sell or distribute medical devices and in vitro diagnostic (IVD) devices in the country.

The draft rules, issued by the Indian Ministry of Health and Family Welfare, would amend the country’s Medical Device Rules, 2017, and will come into force upon their final publication in the Official Gazette of India. The draft rules include application requirements, as well as policies for validity, suspension and cancellation of medical device and IVD registration certificates.

Applying for a medical device or IVD registration certificate in India

The new rules would affect any person or entity seeking to sell, supply, exhibit or distribute a medical device or IVD in India. Applications for registration certificates must be submitted to a state licensing authority rather than to the Central Drugs Standard Control Organization (CDSCO).

An application for registration certification must include:

  • Payment for applicable fees
  • Self-certificate of compliance to Good Distribution Practices (GDP)
  • Details and identification of applicant
  • Details regarding competent and qualified technical staff who will carry out sale and/or distribution of the device in question

State licensing authorities will accept or reject applications within 10 days, according to the text of the draft rules. Once a registration certificate has been obtained, the certificate holder is responsible for maintaining inspection records; state licensing authorities rather than the CDSCO will carry out inspections, as well.

Validity of registration certificates

The draft rules state that registration certificates will not have expiration dates. However, certificate holders must ensure payment of a retention fee within five years of issuance. Failure to pay retention fees will result in cancellation of a registration certificate.

Learn more about medical device and IVD regulations in India:

Author

  • Stewart Eisenhart

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