Eliminate Restriction of being Sole Representative to Import from OEMs
Reform ID F118
Reform Description Before: In the medical devices rules it was permitted that only a sole representative can import from original equipment manufacturers.

After:  Through an amendment the condition of sole representative has been done away with. Now multiple importers of similar brand are allowed to import the medical devices from same OEM

Sector Healthcare
Beneficiaries All Healthcare Businesses
Jurisdiction/ Location Federal (Entire Pakistan)
Department Drug Regulatory Authority of Pakistan
Date of Implementation 27-04-2022
Details Difficulty It was required in the medical devices rules that only a sole representative can import the medical devices from original manufacturers. This condition was a bottleneck in the way of promoting the competition in the market and ensuring the required availability of medical devices.
Analysis On the complaint of private sector it was observed that this condition of allowing import by a sole representatives is against the principle of fair play and put a single entity at an advantage which consequently becomes a hegemon in the market.
Solution The condition to allow import by a sole representative has been amended and now multiple importers can import directly from the Original Equipment Manufacturers.
Evidence Notification

Was this information helpful?