Last Updated on January 9, 2024 by The Health Master
Download notification, link given below: The ministry of health and family welfare has issued final notification amending the rules related to the grant of import license for the medical devices to allow 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 vide Notification No. GSR 174(E) dt 04-03-2022.
The amendment is by adding the United Kingdom also to the list of nations including the United States of America, which are currently allowed to import under this provision.
The amendment, namely Medical Devices (2nd Amendment) Rules, 2022, was notified after the objections and suggestions received from the public and stakeholders were considered, said the Ministry.
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.
A draft amendment was proposed and published on December 10, 2021, in the Gazette of India, 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.
Licensing procedure for Medical devices
Latest Notifications: Medical Devices
Classifications of Medical Devices under the provisions of MDR 2017
FAQs on Medical Devices Rules, 2017
FAQs – on Blood Pressure Monitoring Devices
ICMR in collaboration with pharma companies to develop Dengue vaccine
DCGI gives nod to Zydus Oxemia to treat anaemia
Pfizer recalls this BP drug on potential cancer-causing impurity
Phase-3 Clinical Trial permission of Covovax as booster dose recommended
NPPA fixes retail price of Normal Human Immunoglobulin 5% Solution
Clarification sought from CDSCO on approval status of Clotrimazole 1% mouth paint
Govt recommends imposition of anti-dumping duty on import of Dicyclohexylcarbodiimide from China
USFDA approves expanded use of cancer drug Opdivo
Govt releases draft Unani Pharmacopoeia of India
Latest Notifications regarding Pharmaceuticals
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon:
