ISLAMABAD: 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 was being extended, the Healthcare Devices Association of Pakistan (HDAP) said in a statement.

The HDAP has warned that if extensions are 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 90pc of Pakistan’s medical devices, 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,” it stated.

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 shown concerns over reports on the matter and urged the authorities to ensure that all stakeholders, including regulators, healthcare professionals, and patients, fully understand the gravity of the situation.

The association has reaffirmed its commitment to working with authorities to find a responsible and constructive solution to safeguard the availability of life-saving medical devices in Pakistan.

Published in Dawn, April 3rd, 2025