REGULATORY AUTHORITY: Drug Regulatory Authority of Pakistan (DRAP) – Medical Devices & Medical Cosmetics Division (MD&MC).
CLASSIFICATION SYSTEM: Medical Devices and IVDs: A/B/C/D
TIMEFRAME: New Registration: 3-6 months.
SPECIAL REQUIREMENT:
On-Site Audit: Manufacturing site inspection is sometimes required, especially for medical devices that were not previously approved by the USA, Japan, Australia, Canada, Austria, Belgium, Denmark, France, Germany, Ireland, Italy, Netherlands, Norway, Spain, Sweden, Switzerland, and the United Kingdom. On-site inspection is also exempted if the legal manufacturer is based in EU countries or the USA.
Local Tests/Permit: Local testing is not required; however, the Medical Device Board (MDB). may sometimes require a sample of the enlisted or registered medical device to be sent for analysis or testing.
LOCAL FEES (New Application)
Class A: USD 25
Class B: USD 125
Class C/D: USD 250
LICENSE VALIDITY: 5 years
LICENSE TRANSFER: A certificate of enlistment/registration cannot be transferred to any other establishment without prior written approval from the MDB. If an establishment wishes to transfer its certificate, it must first 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: Foreign manufacturers must appoint a legal entity located in Pakistan in order to comply with the regulations.
