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 AUTHORITY: Drug Regulatory Authority of Pakistan (DRAP) through Medical Device Board (MDB).

CLASSIFICATION SYSTEM:

Medical Devices: Class A/B/C/D 

IVD Devices: Class A/B/C/D

TIMEFRAME: Medical Devices/IVDs (Class A/B/C/D) – 3 to 6 months

LOCAL FEES: New Application fees: Fees range between USD 35 and USD 350 depending on the MD/IVD class.

Manufacturer registration: No manufacturer registration fee is required.

LICENSE VALIDITY: 5 years

LICENSE TRANSFER: The previous LH must cancel and hand over the original certificate to the Medical Device Board (MDB). Only after that the new certificate holder could apply for new enlistment/registration certificate.

AUTHORIZED REPRESENTATIVE/LICENSE HOLDER: A sole representative must be appointed through an official Letter of Authorization (LoA). This authorized representative will also become the license holder and importer.

SPECIAL REQUIREMENTS:

Audit: N/A

Local Tests/Permit: Local testing is not required, however, at any time after the enlistment/registration certificate is issued, sample might be required for appropriate analysis or testing.

Clinical Evaluation or Studies: N/A

Last updated on December 17, 2019

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