Allow Authorized Distributor to Import Medical Devices on Authorization by Registration Holder, in Line with International Practices
Reform ID F117
Reform Description Before: Only registered importers were allowed to import medical devices whereas their authorized agents/ distributors were not able to import the already registered medical devices.

After:   In line with the international best practices now authorized distributors of registered importers can import medical devices from international manufacturers of Medical Devices
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 Only registered importers were allowed to import medical devices whereas their authorized agents/ distributors were not able to import the already registered medical devices.
Analysis It was concluded from discussions that once the medical device being imported is registered with DRAP and registered importers allows his authorized agent to import the devices, it will facilitate the industry and work as a enabling factor for the businesses in this segment
Solution DRAP has now allowed authorized distributors/ agents of registered importers to import registered medical devices.
Evidence Notification

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