Medical Devices Registration Exemption in Pakistan

By Fajar Dumadi | October 20, 2021

According to the Medical Device Rules 2017, “A medical device that is essential to or that yields information that is essential to the restoration or continuation of a body function important to the continuation of human or animal life” are exempted from either Establishment Certificate and/or Enlistment/Registration Certificate. Those medical devices are: Electrophysiology Items, Pediatric Cardiology, Cardiac Surgery & Anesthesia Disposables, and Angiography & Angioplasty. The complete list of medical devices that fall under this category can be found in Schedule D: List of life-saving or life-sustaining medical devices (1. Cardiovascular and allied medical devices) of the Medical Devices Rules, 2017.

However, none of these devices can be imported, sold, and used in Pakistan unless they satisfy either of these conditions:

• Previously approved for use and sale by the regulatory authorities of the reference countries such as USA, Japan, Australia, Canada, Austria, Belgium, Denmark, France, Germany, Ireland, Italy, Netherlands, Norway, Spain, Sweden, Switzerland, and the United Kingdom
• CE marked by a manufacturer whose conformity assessment is performed by conformity assessment bodies notified in the NANDO database under the relevant European directive for medical devices.

This exemption will be valid only until the exemption period is over:

• Class D medical devices – 31 March 2022
• Class B medical devices – 30 June 2022
• Class C medical devices – 20 September 2022
• Class A medical devices – 31 December 2022

During the exemption period, the importer of devices in Schedule D must provide the following documents during the customs clearance process:

Although exempted, such devices may still be registered under a regular process. However, when the exemption period is over, such devices must be registered to DRAP and there will be no restrictions to import or distribute.