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.
Last updated on November 17th, 2021.
Medical Device Regulations and Classification in Pakistan
REGULATORY AUTHORITY: Drug Regulatory Authority of Pakistan (DRAP)
Medical Devices and IVDs: Class A/B/C/D
TIMEFRAME: New Registrations: 3 to 6 months
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.
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.
According to MD Rules 2017, the following devices are exempted from either Establishment Certificate and/or Enlistment/Registration Certificate:
- Electrophysiology Items.
- Pediatric Cardiology.
- Cardiac Surgery & Anesthesia Disposables.
- Angiography & Angioplasty.
The complete list of medical devices that fall under this category can be found in Schedule D: List of life-saving or life-sustaining medical devices (1. Cardiovascular and allied medical devices) of the Medical Devices Rules, 2017.
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