The ministry of health and family welfare has amended the Rules related to the grant of import license for the medical devices, allowing products with a free sale certificate from the drug regulator of the United Kingdom also to be issued import license in the country without clinical investigation. The rule already has this provision to products with certification from nations including the United States of America.

According to a draft notification issued by the Ministry, the amended rules, namely Medical Devices (…Amendment) Rules, 2021, which shall come into force on the date of their final publication in the Official Gazette.

The amendment says that in the Medical Devices Rules, 2017, in the Rule 35, in Sub-Rule (3), for the words “or the United States of America”, the words “United Kingdom or the United States of America” shall be substituted.

The Rule 36 of the Medical Devices Rules is regarding the requirements for the grant of import licence, wherein it says that after the examination of documents furnished with the application and on the basis of the inspection report, if inspection has been carried out, the Central Licensing Authority may, on being satisfied, grant licence in Form MD-15 or, may reject such application for which reasons shall be recorded in writing within a period of nine months from the date of application.

Under the Sub-Rule (3), it stipulates that 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 licence shall be granted as per the provisions, without carrying out clinical investigation. It is to this provision, the amendment adds the name of the United Kingdom.

When the medical device is imported from countries other than those referred to in sub-rule (3), the licence in case of Class C and Class D medical devices may be granted after its safety and effectiveness has been established through clinical investigation in India as specified under provision of Chapter VII of these rules, according to the Medical Devices Rules.

The draft amendment has been proposed and published after consultation with the Drugs Technical Advisory Board for information of all persons likely to be affected. The Ministry also issued notice that the draft amendment shall be taken into consideration on or after the expiry of a period of 45 days from the date on which copies of the Gazette of India containing these draft rules are made available to the public.

Objections and suggestions, if any may be received from any person within the period specified, will be considered by the Central government, added the draft notification.