In a significant development for Pakistan’s medical device industry, Federal Health Minister Syed Mustafa Kamal has assured the leadership of Healthcare Devices Association of Pakistan (HDAP) that the longstanding issue of medical device registration will be resolved in coming few days.
Calling it a “complex and lingering problem,” the minister pledged to take immediate action to ensure the continued availability of critical healthcare equipment across the country.
The assurance came during a high-level meeting between the federal health minister and an HDAP delegation at the Central Drug Testing Laboratory in Karachi. The delegation was led by HDAP’s Chairman Syed Omer Ahmed and included Senior Vice Chairman Shahan Irshad, former Chairmen Dr. Zaffar Hashmi & Masood Ahmed, and former Vice Chairman Abid Maniyar.
The HDAP delegation presented a comprehensive overview of the mounting regulatory challenges in the sector, particularly the urgent need to extend the exemption period for registration of medical devices under the Medical Devices Rules (MDR) 2017.
“DRAP claims to have processed hundreds of registration applications, but certificates are still not being issued, which has caused customs authorities to withhold shipments,” HDAP office-bearers informed the minister.
They added that the Drug Regulatory Authority of Pakistan (DRAP) had previously asked HDAP not to submit registration applications for Class A and B medical devices due to a lack of manpower and the inability to handle a high volume of applications.
“DRAP also assured us that registration timeline extensions would be granted to facilitate the industry, but they are now going back on their commitments,” said HDAP Chairman Syed Omer Ahmed.
The delegation warned that the failure to extend the deadline could trigger a national health crisis, with over 7,000 registration applications still pending.
Delegation also noted that DRAP had suspended the registration process, citing the need for federal cabinet approval, but the absence of progress and clarity has created serious uncertainty among importers and healthcare providers.
Syed Omer Ahmed emphasized that the delays directly threaten the availability of essential medical equipment used in diagnostics, surgeries, intensive care units, and patient monitoring—particularly in public and private hospitals nationwide.
The HDAP team also expressed concern over the lack of transparency in DRAP’s regulatory proceedings, pointing out that recent meetings of the Medical Device Board (MDB) had not been followed by the release of agendas or meeting minutes. They questioned DRAP’s claims of rapid progress, noting that the average application processing time remains between three to four years, with little evidence of improvement.
The delegation urged the government to align Pakistan’s regulatory framework with international standards, pointing to the European Union’s MDR/IVDR transition period, which extends through 2027–28. They called for a more pragmatic approach that includes the acceptance of international certifications such as CE and FDA approvals, as well as Letters of Authorization (LoAs), to streamline the registration process.
Minister Mustafa Kamal responded positively, appreciating HDAP’s constructive input and recognizing the industry’s vital role in supporting Pakistan’s healthcare system. He assured the delegation that the matter would be fast-tracked and all necessary administrative steps would be taken to avoid disruption in the supply of essential medical devices.
Reaffirming its commitment to national healthcare, HDAP pledged to continue working closely with the Ministry of National Health Services and DRAP to build a more efficient, transparent, and internationally aligned regulatory system. The association also offered support in strengthening institutional capacity and shaping long-term policy, including the promotion of local manufacturing.
As Pakistan faces ongoing economic and health challenges, resolving this regulatory bottleneck is seen as essential to ensuring uninterrupted medical services and safeguarding public health across the country.
