The consignment of medical device should be accompanied by an invoice or statement showing the name and quantity of the medical device. If applicable the medical device should be accompanied by a package insert or user manual. The licence should also be produced to the State or Central Medical Device Officer or his seniors, as the case may be.
The administrative actions like market withdrawal, regulatory restrictions, cancellation of authorization, declaring as not of standard quality by the regulatory authority of any country should be informed forthwith to the licensing authority forthwith and in all cases within 15 days. In such cases, the authorized agent should stop the dispatch and marketing of such medical devices immediately and should comply with the directions including withdrawal of medical device from Indian market within a period as specified by the Licensing Authority. The licencee should recall the medical devices, entire batch or all batches, if directed so by the licensing authority for non conformance with the provisions of the Act and rules.
If any major change as specified in the sixth schedule need to be performed, prior approval from the Central licensing authority is required. The approval is granted within 60 days and in case no communication is provided, such changes are deemed to be approved. Any minor change as specified in the sixth schedule should be informed within 30 days of such change. If there is any change in the constitution of the overseas manufacturer or the authorized agent, it should be informed within 30 days.
Change in constitution
If there is a change in constitution, including the overseas manufacturer who executed the power of attorney, an application for the grant of licence should be made within 180 days from the date of change in constitution. The existing licence shall be deemed to be valid till such time, a fresh licence is issued or application is rejected by the Licensing Authority. However no provisions for appeal to the Central Government are provided if the application is rejected by the Central Licensing Authority.