Pakistan’s healthcare sector is facing a critical challenge as thousands of life-saving medical devices and diagnostic products remain stuck in the registration process, medical device importers have warned.
The Healthcare Devices Association of Pakistan (HDAP) raised alarm over the Drug Regulatory Authority of Pakistan’s (DRAP) failure to process new registration applications for Class A and B medical devices over the past 18 months. Despite repeated assurances from DRAP about extending the deadline, the authority has not officially accepted new applications, creating a growing crisis in the healthcare supply chain.
HDAP, which represents over 300 importers and manufacturers supplying 90% of Pakistan’s medical devices, cautioned that without urgent intervention, hospitals nationwide could face severe shortages. Delays in registration could disrupt essential medical procedures, including cardiac surgeries, organ transplants, and intensive care treatments, putting millions of patients at risk.
An estimated backlog of 6,000 to 8,000 applications remains unprocessed, preventing the import of essential medical equipment. Additionally, shipments of vital medical supplies are stranded at ports, further straining hospitals and patients relying on critical diagnostic and treatment tools.
HDAP has called on the government to take immediate action by streamlining the registration process and officially extending the deadline to prevent disruptions in patient care. The association also plans to issue a detailed clarification after the Eid holidays to counter misleading reports and ensure that regulators, healthcare professionals, and the public fully grasp the severity of the situation.
HDAP officials reaffirmed their commitment to working with authorities to find a constructive solution that safeguards the availability of life-saving medical devices in Pakistan.