The Union health ministry will soon amend sub rule (3) of Rule 36 of Medical Device Rules (MDR)-2017 to include United Kingdom (UK) in the list of countries which recognize its Free Sale Certificate (FSC) for granting import license.
This move comes in the wake of national regulatory authority of UK – the Medicines and Healthcare products Regulatory Agency (MHRA)’s request to the union health ministry to add UK to the list of the countries to recognize the FSC issued by the MHRA along with the countries namely, Australia, Canada, Japan, European Union Countries, and the United States of America for granting an import license.
The health ministry has considered the request based on the Drugs Technical Advisory Board (DTAB) recommendation as the UK under the current scenario is being separated from the European Union (EU). As per the recommendation, the request of the UK may be considered for appropriate action/ amendment in the MDR – 2017 as per the procedures for amendment in the rules, prescribed under the Drugs and Cosmetics (D&C) Act, 1940.
Under sub rule (3) of Rule 36 of Medical Device Rules, 2017, FSC issued by the National Regulatory Authority or other competent authorities of EU Countries were already recognized and the UK was part of the EU at that point of time.
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Hence, FSC issued by the National Regulatory Authority of UK was also accepted for considering the marketing approval.
A FSC is a certificate issued by a national regulatory authority of an exporting country based on national legislation confirming that the product is freely sold in the country but without any indication that the product is evaluated for safety and efficacy and is registered for use in the country.
In India, the state licensing authority (SLA) is responsible for issuing FSC for export purposes. A Free Sale Certificate is also known as a “Certificate for Export” or “Certificate to Foreign Governments”.
The same was deliberated at DTAB meet in Delhi recently and it was apprised that United Kingdom has requested to add UK to the list of the countries to recognize the FSC issued by the National Regulatory Authority of UK along with other countries for granting an import licence under sub-rule (1) of Rule 36 of the MDR- 2017 to applicants without further clinical investigation of the products.
DTAB deliberated the matter and agreed to amend the sub rule (3) of Rule 36 of the MDR, 2017 to include the country “United Kingdom” along with existing countries specified in the said Rules.
As per sub-rule (3) of Rule 36 of Medical Device Rules, 2017 “Where, a free sale certificate has already been issued in respect of any medical device by the national regulatory authority or other competent authority of any of the countries namely, Australia, Canada, Japan, European Union Countries, or the United States of America, a license shall be granted under sub-rule (1) to the applicant without carrying out clinical investigation.”
MDR 2017 was notified by the union health ministry on January 31, 2017 and the same was implemented with effect from January 1, 2018.
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