;   Medical Translation Insight: Pakistan gets regulatory system for medical devices - ForeignExchange Translations

Pakistan gets regulatory system for medical devices - medical translation
As in many smaller Asian countries, medical device regulations in Pakistan were, shall we say, "flexible". Although the Pakistani government had tried to implement medical device regulations, the 35-year-old regulations were woefully out of date with today's global economy. This resulted in lots of miscommunications, backroom deals, complaints, and, above all, uncertainty.

Well, that's about to change.

MassDevice just reported that the Pakistani government has signed into law legislation [PDF and, in case of problem, cached HTML] to "formally regulate medical devices and pharmaceutical products in the country".

The "Drug Regulatory Authority of Pakistan Act" will establish a Drug Regulatory Authority of Pakistan, which be responsible for managing and enforcing the country's Drug Act of 1976.

According to MassDevice:
  • 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.
  • 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.
Other than that, details are sketchy but for a bit more, read the MassDevice article, an article on the topic at The Nation, and the response from the Pakistan Pharmaceutical Manufacturers' Association.


ForeignExchange Translations provides specialized medical translation services to regulatory groups at medical device and pharmaceutical companies.
 

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