Webinar: Medical Device Regulations in Pakistan
The webinar, led by Priya Bhutani, discusses new medical device regulations in Pakistan, which were implemented last year. It features Dr. Muhammad Sohail, a regulatory affairs expert from Pakistan, who provides insights into the historical context and recent developments in medical device regulation.
Before the current regulations, medical devices in Pakistan were primarily governed under the Drug Act of 1976, with limited implementation of rules published in 2015 due to the lack of a conformity assessment body. The Drug Regulatory Authority of Pakistan (DRAP) was formed in 2012, and it established the Medical Device and Medicated Cosmetics Division, which published the new Medical Device Rules in 2017.
Dr. Sohail outlines the classification system for medical devices, which includes Class A to D based on risk, as well as Schedule D for life-saving devices. He explains that the classification aligns with international standards, facilitating smoother market entry for foreign manufacturers.
The new regulations require all establishments dealing with medical devices to obtain an establishment license and register their products before importation or sale. The process includes specific documentation, although foreign clinical data is acceptable for certain classifications.
The discussion also touches on the appeal process for rejected applications, indicating that aggrieved parties can present their cases to an appellate board. Additionally, the timeline for product registration can vary, generally taking six to nine months, but faster for products already approved by recognized regulatory bodies.
The webinar concludes with a Q&A session, encouraging audience participation and feedback.