Medical Device Registration and Approval in Pakistan

General country-specific regulatory information is provided on this page for medical device registration and approval in Pakistan. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, including Pakistan, to expedite the preparation of your medical device or IVD registration application.

Medical Device Regulations and Classification in Pakistan

REGULATORY AUTHORITYNational Centre for Medicines, Medical Devices, and Medical Equipment Expertise

CLASSIFICATION SYSTEM:

Medical Devices and IVDs: Class A/B/C/D 

TIMEFRAME: New Registrations:  3 to 6 months

LOCAL FEES: 

Class A – USD $35

Class B – USD $175

Class C – USD $350

Class D – USD $350

LICENSE VALIDITY: 5 years

LICENSE TRANSFER: License transfer is possible. If an establishment wishes to transfer its certificate, first they must cancel it. Within 14 days after the cancellation date, the establishment should hand over the original certificate to the MDB. Afterward, the new establishment could apply for the enlistment/registration license on their behalf.

AUTHORIZED REPRESENTATIVE/LICENSE HOLDER: Foreign manufacturer should appoint a legal entity in Pakistan with a valid establishment license to become their sole authorized representative.

SPECIAL REQUIREMENTS:

On-Site Audit: Manufacturing site inspection is sometimes required especially for medical devices that has never been registered by regulatory authorities such as USA, Japan, Australia, Canada, Austria, Belgium, Denmark, France, Germany, Ireland, Italy, Netherlands, Norway, Spain, Sweden, Switzerland and United Kingdom or pre-qualified by World Health Organization or CE marked through conformity assessment bodies (CABs).

Local Tests/Permit: In-country local testing is not required, however, the MDB may sometimes require a sample of the enlisted or the registered medical device to be sent for analysis or testing.

Local Clinical Evaluation or Studies: Not required.

Last updated on November 1, 2020

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