(1) If the State Licensing Authority or the Central Licensing Authority, as the case may be, after such further enquiry, if any, as may be considered necessary, is satisfied that the requirements of these rules have been complied with, it shall issue a licence in Form MD7, or loan licence in Form MD8, as the case may be:
Provided that where a manufacturing licence has been granted to any manufacturer under Drugs and Cosmetics Rules, 1945, before the date of commencement of these rules, such manufacturing licence shall be deemed to have been granted as licence under the provision of these rules for the remaining period of the said licence.
(2) If the State Licensing Authority or the Central Licensing Authority, as the case may be, is not satisfied, it may reject the application and shall inform the applicant 15 of the reasons in writing for such rejection.
Conditions for manufacturing licence or loan licence.
21. After the grant of licence or loan licence, the licence holder shall comply with the following conditions, namely:-
(i) licence shall be kept on the approved premises and shall be produced when requested by the Medical Device Officer;
(ii) the licence holder shall inform about the occurrence of any suspected unexpected serious adverse event and action taken thereon including any recall to the State Licensing Authority or Central Licensing Authority, as the case may be, within 15 days of such event being brought to the notice of licence holder;
(iii) the licence holder shall inform forthwith any major change as specified in the Sixth Schedule to the State Licensing Authority or Central Licensing Authority, as the case may be, for its approval;
(iv) the licence holder 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;
(v) the licence holder shall inform the State Licensing Authority or the Central Licensing Authority, as the case may be, in writing within a period of thirty days in the event of change other than change of constitution of the manufacturer or change referred in condition (iii) above. The manufacturer shall submit the confirmation that no changes in specification, labelling or technical staff has been made;
(vi) the licence holder shall carry out test of each batch of final product prior to its release for compliance to specification either in his own testing centre or in any accredited testing centre and shall maintain records of such tests for a period of one year after expiry of the medical device;
(vii) the licence holder shall, on being informed by the Central Licensing Authority or State Licensing Authority, as the case may be, that any part of any lot of the medical device has been found by the licensing authority not conforming with the provisions specified under the rules and on being directed so to do, withdraw the remainder of that lot from sale and, so far as may, in the particular circumstances of the case, be practicable, recall the issues already made from that lot;
(viii) the licence holder shall maintain an audit or inspection book in Form MD9 to enable notified body or medical device officer to record his impressions and the defects noticed;
(ix) the licence holder shall maintain at least two units of samples from each batch of the invasive medical device manufactured by him for reference purpose.
(x) the license holder shall maintain records of manufacturing and sales which shall be open to inspection by a medical device officer.
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(xi) the licence holder shall supply the medical device for sale, offer for sale along with its package insert.
(xii) in case if the manufacturer has closed down the manufacturing site, the same shall be intimated to the Central Licensing Authority or State Licensing Authority, as the case may be.
Fresh Application in case of change in constitution.
22. In case of change in constitution after grant of licence under rule 20, the manufacturer shall make an application under rule 15 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, a fresh licence is issued or application is rejected by the State Licensing Authority or the Central Licensing Authority, as the case may be.
Unannounced audit by State Licensing Authority.
23. The State Licensing Authority shall have at least two per cent. of the cases of licence recommended by every Notified Body annually, audited by its officers, and such cases shall be selected on a random basis.
Duration of licence. 24. (1) A licence or loan licence shall remain valid, unless, it is suspended or cancelled, provided the licence holder deposits a licence retention fee as specified in the Second Schedule in every five years from the date of its issue.
(2) If the licence holder 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 fee for every month or part thereof up to six months, in the event of non-payment of such fee, the licence shall be deemed to have been cancelled.
Suspension and cancellation of manufacturing licence.