38. Conditions to be complied with by Licence holder.
(1)The licencee 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 the State Licensing Authority, as the case may be;(ii)the licencee shall inform the licensing authority forthwith and, in all circumstances, within a period of fifteen days of any administrative action taken on account of any adverse reaction, such as market withdrawal, regulatory restrictions, cancellation of authorization or declaration of the medical device as not of standards quality 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)authorized agent in cases referred in clause (ii), shall stop immediately the despatch and marketing of the medical device referred in that clause;(iv)the Central Licensing Authority, after due consideration of the information as referred in clause (ii), may issue directions to the licencee in respect of marketing, sale or distribution of the medical device including withdrawal of medical device from the Indian market within a period as may be specified by the Central Licensing Authority;(v)the authorized agent shall obtain prior approval from the Central Licensing Authority before any major change, as specified in the Sixth Schedule, is carried out and the Central Licensing Authority shall indicate its approval or rejection within sixty days;(vi)in case, no communication of approval or rejection as referred to in clause (v) is received within the stipulated time from the Central Licensing Authority, such change shall be deemed to have been approved;(vii)licencee shall inform, any minor change as specified in the Sixth Schedule to the Central Licensing Authority within a period of thirty days, after such minor change took place;(viii)authorized 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;(ix)the consignment of medical device shall be accompanied by an invoice or statement showing the name and quantity of the medical device;(x)the licencee shall supply the medical device for sale or offer it for sale along with its package insert or user manual, wherever applicable.(2)Where the Central Licensing Authority is satisfied that any medical device is not in conformity with the provisions of the Act and these rules, it may issue directions that the entire batch of such medical device may not be sold or offered for sale or may be recalled from the market including hospitals, if any, where it has been stocked:Provided that where the Central Licensing Authority considers it necessary or expedient, more than one batch or all batches of such medical device may be directed to be recalled.
