Healthcare crisis looms as medical device registration delay not resolved

The registration of life-saving medical devices and diagnostic products in Pakistan has become a critical issue with thousands of applications still pending approval, medical device importers have warned.

Despite the urgency of the situation, the Drug Regulatory Authority of Pakistan (DRAP) did not accept new applications for the registration of thousands of Class A and B devices for the last one-and-a-half years, assuring importers that the deadline for their registration would be extended, the Healthcare Devices Association of Pakistan (HDAP) said in an emergency statement on Sunday.

The HDAP warned that if extensions were not officially granted, hospitals across the country could face severe shortages, putting millions of patients at risk.

Representing over 300 importers and manufacturers responsible for supplying 90 per cent of Pakistan’s medical devices, the HDAP cautioned that delays in the registration process could disrupt critical medical procedures, including cardiac surgeries, organ transplants and intensive care treatments.

Currently, a backlog of 6,000 to 8,000 applications remains unprocessed, preventing importers from bringing in essential medical equipment. Shipments of vital medical supplies are already stuck at ports, directly impacting hospitals and patients who depend on modern diagnostic tools and treatment devices.

The HDAP has urged the government to take immediate action by streamlining the registration process and extending the deadline to prevent disruptions in patient care.

The association has also taken serious notice of misleading reports on the matter and plans to issue a detailed clarification after the Eid holidays to ensure that all stakeholders, including regulators, healthcare professionals and patients, fully understand the gravity of the situation.

HDAP officials reaffirmed their commitment to working with authorities to find a responsible and constructive solution to safeguard the availability of life-saving medical devices in Pakistan.