As per Medical Devices Rules 2017 an establishment is allowed for contract manufacturing and analysis as per described procedure.

1. MEDICAL DEVICE CONTRACT
MANUFACTURING / ANALYSIS
IN PAKISTAN

2. Contract Acceptor:
A person performing manufacturing/analysis outsourced by the establishment licence holder
and is responsible for the following
Should successfully carry out work
Should have adequate premises, equipment, knowledge, experience, and
competent personnel
Should ensure that products or materials delivered are suitable
Should not pass any work to a third party

3. Contract Giver:
A person possessing establishment licence and is responsible for the following
Should provide registration information
Should be aware of associated challenges
Should ensure specifications
Should perform in process controls
Should successfully carry out work Should keep sample for analysis
Should keep record to assess the quality
Should recall products
Should release the product for marketing

4. Form-1 (A)
or
Form-1 (B)
Form- 3 (A)
Or
Form- 3 (B)
Inspection
Satisfactory
Inspection Report
Consideration
by MDB
Procedure for Outsourcing Permission Certificate

5. “
”