Pakistan’s government approved new rules regulating the sale of medical devices for the first time.
The rules, approved in a Dec. 26 cabinet meeting, will apply to all medical devices. Prior to their approval, the country’s only law regulating trade for medical devices was the 1976 Drugs Act.
The new rules come after years of complaints about lower quality devices being sold as higher-quality ones, according to local media reports.
The new rules will reform the device fee structure and simplify requirements for technical documentation during the registration process for devices imported from key reference countries, including the United States, Japan, Canada, Australia and the European Union.
The rule also harmonizes device classifications to better align with guidelines established by the World Health Organization, the Asian Harmonization Working Party and the International Medical Device Regulators Forum. — Zack Budryk