Minister promises resolution of medical devices’ registration deadlock

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KARACHI: Federal Health Minister Syed Mustafa Kamal has assured the Healthcare Devices Association of Pakistan (HDAP) to resolve the delay in registration of medical devices over the next few days, which has led to an increase in the provision of important health care equipment throughout the country.

Describing the issue as a “complex and long -standing challenge”, the minister promised to take immediate administrative steps to prevent further delays in the registration process of medical equipment and to ensure unabashed access to both public and private health facilities in both public and private health facilities.

The assurance took place during a high level meeting at the Central Laboratory of Drug Extension in Karachi, where Kamal met a delegation of HDAP Office Bears. The delegation was led by former HDAP chairman Masood Ahmed and included current chairman Syed Omar Ahmed, senior vice chairman Shahhan Irshad, former chairman Dr Zafar Hashmi, and former vice chairman Abid Munir.

During the meeting, representatives of HDAP presented the growing regulatory difficulties facing the medical devices sector, especially the urgent need to extend the immunity period under medical devices Rules (MDR) 2017.

HDAP representatives told the minister, “Pakistan’s Drug Regulatory Authority (DRAP) has claimed to have taken hundreds of registration applications, but certificates are not being issued, which has helped customs officials stop the shipment.”

He added that the drip had earlier told the HDAP not to submit registration applications for class A and B medical devices due to lack of human resources and inadequate ability to handle applications.

HDAP Chairman Amir Ahmed said, “This drop also promised us that the last date of registration will be extended to support the industry, but now they are backing out those promises.”

The delegation has warned that failure to expand the deadline can lead to a national health crisis, more than 7,000 registration applications are still pending. Ahmed noted that this drop has stopped the registration process, citing the need for the approval of the federal cabinet. However, the lack of clarification and progress has left the market in the organs, which has equally affected importers and healthcare services providers.

He emphasized that the delay in processing could result in severe shortage of life -saving goods, especially in hospitals across the country under the supervision of surgery, ICU, and patients.

The HDAP team also raised concerns about “lack of transparency” in drip regulatory operations, indicating that the recent medical device board (MDB) meetings was not done after the agendas or minutes of publication. He also challenged the claims of the DRAP of high -speed processing, highlighting that the time for change in the application is still between three and four years, with very little sign of action.

The delegation called on the government to refer to the European Union’s MDR/IVDR transfer period, compatible the country’s regulatory framework in a global way, which has been increased during 2027-28. He proposed to adopt another practical approach to simplify the registration process, which includes acceptance of international certificates such as CE and FDA approval, and recognition of letters (LOA).

The Minister praised the input of HDAP and recognized the industry’s important role in maintaining the country’s health care infrastructure. He assured the delegation that the matter would be resolved on a high -speed track and all necessary steps would be taken to ensure the continuous supply of important medical equipment.

Repeating support for the Ministry of Health, the HDAP delegation has promised to work in partnership with both the National Health Services and DRAP to create a regular environment that not only meets global standards but also promotes local manufacturing and supports long -term policy development. The association also agreed to help enhance institutional capacity and transparency in the regulatory efforts in the future.

Since Pakistan is facing health care and economic challenges, stakeholders are essential to ensuring any interference and protecting public health across the country.