Guidelines for the implementation of medical device regulatory system under Medical Act 2012 (Act 737)
Guidelines are prepared to assist medical device industries during implementation of medical device regulatory system.
List of guidelines are as follow:
|MDA/GL/MD-01||How to Apply for the Medical Device Registration under Act 737|
|MDA/GL No. 2||How to apply for establishment License under medical device act 2012 ( Act 737)|
|MDA/GL No. 2||How to Apply for Apply for In-Vitro Doagnostic (IVD) the Medical Device Registration under Act 737|
|MDA/GL/04||Application For Medical Device Advertisement Approval - Requirements|
|MDA/GL/05||Conditional Approval For COVID-19 Self-Test Kit (Document under revision)|