83. Application for Registration of a Medical device

The Authority shall maintain a register in which every application received for the registration and licensing of a medical device shall be recorded.

The particulars to be entered in such register shall be as prescribed.

to the MDEC, for the evaluation of the application and the medical device considering the need to ensure the availability of efficacious, safe and good quality medical device relevant to the healthcare needs of the public at an affordable price; and

to the NMQAL, for testing of the quality of the medical device.

setting out the procedures to be followed, by the

specifying—

the time-limits in conducting such testing or evaluation;

the manner in which the MDEC to conduct its meetings and the procedure to be followed at such meetings; and

the matters which should be included in the reports to be submitted.

The Authority may require the MDEC and the

The MDEC and the NMQAL shall within the time limits specified submit their reports to the Authority unless there are compelling reasons for any delay.