(1) On receipt of an application under sub-rule (2) of rule 30, the Central Licensing Authority shall, on being satisfied about the information and the documents enclosed with the application, grant the licence in Form MD13:
Provided that where licence has been granted to the authorised agent before the date of commencement of these rules, such licence certificate shall be deemed to have been granted under the provisions of these rules for the remaining period of the said licence.
(2) A licence shall be granted under sub-rule (1) if the medical device is having free sale certificate from the national regulatory authority or competent authority of the United States of America, European Union countries, Canada, Australia and Japan.
(3) Where the medical device is proposed to be imported from countries other than those referred to in sub-rule (2), the licence in case of Class C and Class D medical devices may be granted after its safety and effectiveness has been proved or established through clinical investigation in India as specified under Part VII of these rules.
Duration of licence. 33. (1) A licence shall remain valid, unless, it is suspended or cancelled, provided the authorised agent deposits a licence retention fee as specified in the Second Schedule for each overseas manufacturing site and for each device in every five years from the date of its issue
(2) If the authorised agent fails to pay licence retention fee on or before the due date as referred to in sub-rule (1), he shall be liable to pay licence retention fee along with a late fee calculated at the rate of two per cent. of the licence retention fee for every month or part thereof up to six months and thereafter the licence shall be deemed to have been cancelled.
Conditions to be complied with by authorised agent.
34. The licence holder shall comply with the following conditions, namely:-
(i) The licence shall be kept and made available in the licensed premises;
(ii)The authorised agent shall inform the licensing authority forthwith in the event of any administrative action taken due to adverse reaction, viz. Market withdrawal, regulatory restrictions, cancellation of authorisation or not of standards quality report of any medical device pertaining to this licence declared by the regulatory authority of the country of origin or by any regulatory authority of any other country, where the medical device is marketed, sold or distributed;
(iii) The authorised agent in cases referred in condition (ii), shall stop immediately the dispatch and marketing of the medical device;
(iv) The Central Licensing Authority after due consideration may issue directions in respect of marketing, sale or distribution of the medical device referred in condition
(iii) including withdrawal of medical device from Indian market within a specified time period;
(v) The authorised agent shall obtain prior approval from the Central Licensing Authority in case of any change in the intended use or any major change as 20 specified in the Sixth Schedule of medical devices classified under Class B, Class C or Class D;
(vi) the authorised shall inform forthwith any minor change as specified in the Sixth Schedule to the State Licensing Authority or Central Licensing Authority, as the case may be;
(vii) The authorised agent shall inform the Central Licensing Authority in writing within a period of thirty days in the event of any change in the constitution of the overseas manufacturer or the authorized agent;
(viii) Where the Central Licensing Authority is satisfied that the sample of any medical device is not in conformity with the provisions of these rules, it may issue direction for not to sell or offer for sale, or to recall or withdraw, such medical device;
(ix) the consignment of medical device shall be accompanied by an invoice or statement showing the name and address of the manufacturer and the name and quantity of medical device.
(x) the licence holder shall supply the medical device for sale, offer for sale along with its package insert.
Fresh Application in case of change in constitution.
35. In case of change in constitution after grant of licence under rule 32, the importer shall make an application under rule 30 for grant of licence within a period of ninety days from the date of such change in constitution:
Provided that the existing licence shall be deemed to be valid till such time, the fresh licence is issued or application is rejected by the Central Licensing Authority.
Test licence for import for the purpose of clinical investigations, test, evaluation, demonstration or training