Pakistan
- Regulatory Authority:
Drug Regulatory Authority of Pakistan (DRAP), Medical Devices & Medical Cosmetics Division (MD&MC)
- Registration period:
4-6 months
- Language:
Urdu, English
- Certificate validity period:
5 years
- Authorized Representative:
country resident
- Legislation:
The Drug Regulatory Authority Act, 2012
- Notes:
A site inspection is performed if products have not been registered in the following countries: USA, Japan, Australia, Canada, Austria, Belgium, Denmark, France, Germany, Ireland, Italy, Netherlands, Norway, Spain, Sweden, Switzerland and UK.
Local laboratory testing is not required.
A brief algorithm for registration of medical devices in Pakistan:
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Completion of the application according to the type of registration.
If a local producer, Form 6 for Class A products and Form 7 for Class B, C, D products.
For imports, the applicant completes Form 6A for Class A products and Form 7A for Class B, C, D products.
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