Steps to be taken for registration of medical device in Pakistan as per Medical Device Rules 2017

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