Simplification of Registration Process for Low risk Medical Devices
|Reform Description||Before: The registration process of the Low Risk Medical Devices was cumbersome and registration process for all the medical devices was same.
After: With the risk categories of medical devices in place the registration process for Low Risk Medical devices has been simplified.
|Beneficiaries||All Healthcare Businesses|
|Jurisdiction/ Location||Federal (Entire Pakistan)|
|Date of Implementation||Last 03 Months|
|Details||Difficulty||Healthcare businesses complained that the registration process of Low Risk Medical Devices is overly regulated and getting a simple device like a Tongue Suppresser (a medical device by definition) which carries no risk becomes a tiresome job owing to the associated formalities of registration.|
|Analysis||It was realized that the registration process of the Low Risk Medical devices is heavily regulated which need to be eased to facilitate the businesses and ensure the provision of medical devices in the domestic market.|
|Solution||Now, the registration of Low Risk Medical Devices has been simplified. The simplified registration form is available on the DRAP website.|
|Evidence||DRAP has Already Simplified
Link to Online Portal
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