(1) An application for grant of permission to import or manufacture new in vitro diagnostic medical device shall be made to the Central Licensing Authority in Form MD26 either by an authorised agent or a manufacturer himself, as the case may be, and shall be accompanied with fee as specified in the Second Schedule along with information specified in Part IV of the Fourth Schedule:
Provided new in vitro diagnostic medical device indicated in life threatening, serious diseases or diseases of special relevance to the Indian health scenario, national emergencies, extreme urgency, epidemic and medical devices indicated for conditions, diseases for which there is no therapy, the clinical data requirements may be abbreviated, deferred or omitted, as deemed appropriate by the Central Licensing Authority.
(3) The Central Licensing Authority, after being satisfied, may grant permission to import or manufacture new in vitro diagnostic medical device in Form MD27.
Condition of permission to import or manufacture investigational medical device and new in vitro diagnostic medical device.
59. A permission in Form MD25 or Form MD27 shall be subject to the following conditions, namely:- 33
(1) The medical device shall conform to the specification submitted along with the application;
(2) The permission holder shall submit the Periodic Safety Update Report to the Central Licensing Authority from the date of launch in the market and such report shall be submitted every six month for the first two years, followed annually two years submission.
(3) The permission holder shall inform the date of launch of medical device in the market to the Central Licensing Authority.
(4) The permission holder shall submit the suspected unexpected serious adverse event within fifteen days of the awareness of the event to the Central Licensing Authority.
(5) The label, prescribing information or package insert to be adopted for marketing medical device in the country, shall be got approved from the Central Licensing Authority before the medical device is marketed.
PART IX Duties and Powers of Medical Device Officer, Medical Device Testing Officer and Notified Body Duties of medical device testing officer.
60. The Medical Device Testing Officer shall cause the sample of medical device or portion thereof tested or evaluated as may be sent in a sealed package by the Medical Device Officer or any other persons under provisions of Part IV, V and VII of these rules and shall furnish the report of the result of the test or evaluation in accordance with these rules.
Procedure to be adopted by medical device testing officer on receipt of sample.