Pakistan to Establish Regulatory System for Medical Devices

The Pakistani government has signed into law legislation (PDF) to formally regulate medical devices and pharmaceutical products in the country.

Once established, the Drug Regulatory Authority of Pakistan will be responsible for managing and enforcing the country’s Drug Act 1976. According to the legislation, entities such as the Federal Drugs Control Administration currently dealing with the drug and medical device industries will become part of the new regulatory body.

Within the Drug Regulatory Authority of Pakistan, the Director of Medical Devices and Medical Cosmetics will oversee all device registration and related processes. The Authority will issue guidelines and monitor enforcement of manufacturing licensing and registration of devices, as well as regulate advertising and pricing of devices.

Passage of the pharmaceutical and medical device legislation follows a “devolution” of Pakistan’s Ministry of Health, which shifted healthcare oversight responsibilities away from the Pakistani federal government to the provinces.

Details regarding medical device registration and other requirements the Authority will enforce are not yet available. We will provide further details as we get them.