Conditions for manufacturing licence or loan licence After grant of licence or loan licence in Form MD-5, Form MD-6, Form MD-9 or MD-10, as the case may be, the licence holder shall comply with the following conditions, namely:— (i) licence shall be produced when requested by the Medical Device Officer or any other senior officer under the control of Central Licensing Authority or State Licensing Authority, as the case may be; (ii) the licence holder shall inform the State Licensing Authority or the Central Licensing Authority, as the case may be, of the occurrence of any suspected unexpected serious adverse event and action taken thereon including any recall within fifteen days of such event coming to the notice of licence holder; (iii) the licence holder shall obtain prior approval from the Central Licensing Authority or the State Licensing Authority, as the case may be, before any major change as specified in the Sixth Schedule is carried out and the Central Licensing Authority or the State Licensing Authority, as the case may be, shall indicate its approval or rejection within forty-five days and in case where no communication is received within the stipulated time from such Authority, such change shall be deemed to have been approved; (iv) the licence holder shall inform any minor change as specified in the Sixth Schedule to the State Licensing Authority or Central Licensing Authority, as the case may be, within a period of thirty days after such minor change take place; (v) the licence holder shall carry out test of each batch of product manufactured prior to its release for compliance with specifications either in his own laboratory or in any other laboratory registered under sub-rule (3) of rule 83; Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 30 of 248 (vi) 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 not conforming with the provisions specified under the Act and these rules, and on being directed so to do by such licensing authority, 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; (vii) the licence holder shall maintain an audit or inspection book in Form MD-11 to enable the Notified Body or Medical Device Officer to record his observations and non-conformity, if any; (viii) the licence holder shall maintain at least one unit of sample from each batch of invasive medical device and in vitro diagnostic medical device manufactured for reference purpose for a period of one hundred and eighty days after the date of expiry of such batch; (ix) the licence holder shall maintain records of manufacturing and sales which shall be open to inspection by a Medical Device Officer; (x) the medical device, when offered for sale, shall be accompanied by either its package insert or user manual, wherever applicable; (xi) the manufacturing or testing activity of medical device shall be undertaken only under the direction and supervision of the competent technical staff; (xii) if the manufacturer has stopped manufacturing activity or closed the manufacturing site for a period of thirty days or more, the same shall be intimated to the Central Licensing Authority or the State Licensing Authority, as the case may be.