65. Condition of permission to import or manufacture medical device which does not have its predicate device and new in vitro diagnostic medical device.
- A Permission under rules 63 in Form MD-27 and rule 64 in Form MD-29 shall be subject to the following conditions, namely:-(a)the medical device shall conform to the specifications submitted along with the application;(b)the permission holder of Form MD-27 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 months for first two years followed by submission of the said report annually for the two more successive years;(c)the permission holder shall inform the date of launch of medical device in the market to the Central Licensing Authority;(d)the permission holder of Form MD-27 shall submit the suspected unexpected serious adverse event within fifteen days of the awareness of the event to the Central Licensing Authority.
