The manufacturing or testing activity should be performed only under the supervision of the competent technical staff and at least one unit of sample from each batch of invasive medical device and in vitro diagnostic medical device should be maintained for 180 days after the expiry date. If applicable the medical device should be accompanied by a package insert or user manual. Each batch of medical device should be tested either in own laboratory or any laboratory approved under these rules. The records for manufacturing and sales should be maintained and it should be open for inspection by a Medical Device Officer. The licence should also be produced to the State or Central Medical Device Officer or his seniors, as the case may be. Inspection book in Form MD-11 should be maintained for recording of the observations made by notified body or medical device officer.
If any major change as specified in the sixth schedule need to be performed, prior approval from the concerned licensing authority is required. The approval is granted within 45 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 are any unexpected serious adverse events, it should be informed to the concerned licensing authority within 15 days along with the action taken including recall. The licencee should recall the devices if directed so by the licensing authority for non conformance with the provisions of the Act and rules. If the manufacturing activity is stopped for 30 days or more, the information should be intimated to the concerned licensing authority.
Change in constitution
If there is a change in constitution, the manufacturer has to inform the Central or State licensing authority, as the case may be, within 45 days and make an application for the grant of licence 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. If the application is rejected the applicant may appeal to the Central or State Government, as the case may be, within 60 days.
Validity of the Licence
The licence in Form MD-5, Form MD-6, Form MD-9 or Form MD-10 shall remain Valid in perpetuity unless it is suspended or cancelled, provided the licencee pays the retention fees as specified in the Second Schedule every five years on or before the due date. The late fee is two percent of the retention fee for each month and should be paid within 180 days along with retention fee, failing which the registration certificate is deemed to have cancelled.
Suspension and cancellation of licence
If the licencee fails to comply with any provisions of the Act and these rules, the Central or State Licensing Authority, as the case may be, after giving a show cause may cancel or suspend the license either wholly or in respect of any medical device. The licencee may appeal against the order within 45 days to the Central or State Government. The Government, after giving an opportunity, may confirm, reverse or modify such order. The licensing authority may revoke the suspension order for reasons recorded in writing. The orders of suspension issued or revoked or cancellation of licence would be published in the websites of Central or State Licensing Authority. As per these rules the State or Central Licensing Authorities would not able to revoke a cancelled licence, only the concerned Government are empowered to revoke the cancelled licence.