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.