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Medical device registration
1. Yes
Yes
No
Figure shows the steps to be taken by an applicant to register a medical device Under Medical
Devices Rules 2017 in Pakistan.
MDB = Medical Device Board
*= Inspection will be exempted for specified countries
Classify as per
Schedule B (I)
Grouping as per
Schedule B (II)
medical device &
B (II)
Application on Form 6 or
6A (Class A)
Application on Form 7 or
7A (Class B, C & D)
Comply with all
requirements?
Is the product a
medical device?
MDB Inspection*
Enlistment / Registration