Medical device registration
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The document outlines the steps an applicant must take to register a medical device under Pakistan's Medical Devices Rules of 2017. An applicant must first classify and group their medical device according to Schedule B, then submit either Form 6/6A for lower-risk Class A devices or Form 7/7A for higher-risk Class B, C, and D devices. The application will then be reviewed for compliance, after which the device may be enlisted or registered and approved for use following an inspection, unless exempt.
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