Medical device registrations: TI-P asks DRAP CEO to ensure timely processing through online portal

ISLAMABAD: Transparency International Pakistan (TI-P) has asked the Chief Executive Officer of Drug Regulatory Authority of Pakistan (DRAP) to ensure timely processing of medical device registrations through the online portal, amid reports of delays stretching over several months.

In a letter addressed to the CEO DRAP, TI-P stated that it had received a complaint alleging delays in registration and licensing approvals of medical devices by the Medical Devices and Medicated Cosmetics (MDMC) Division of DRAP, adversely affecting local importers and patients.

According to the complaint, the MDMC Licensing and Product Registration Portal — a digital platform launched in July 2025 by the Prime Minister, the Federal Minister, and DRAP — was introduced to replace the previous manual and semi-digital procedures for medical devices. The portal enables manufacturers and importers to submit and manage regulatory applications online.

Medical devices in Pakistan were previously regulated under manual procedures, which required considerable time for processing and approvals. DRAP enacted the Medical Devices Rules, 2017, and further strengthened the regulatory framework with the launch of the digital portal in July 2025 to streamline the system.

The Federal Government had launched the portal with the objective of expediting approvals within 20 days. However, the complaint alleges that despite the passage of more than six months since its launch, the MDMC Division has failed to fully implement the registration process through the portal. Consequently, numerous applications from local importers remain pending.

TI-P noted that several local importers have expressed serious concern over the continued delays, warning that the situation is affecting the timely availability of essential medical products and healthcare supplies for patients.

After reviewing the complaint, TI-P stated that, prima facie, the allegations appear to hold merit. It has requested the CEO DRAP to investigate why, despite eight to nine months having passed since the launch of the online platform, the MDMC Division continues to rely on the old manual process.

TI-P has urged the DRAP chief to issue necessary directives to address the delays and ensure full compliance with the online portal system for timely approval of medical devices.

Copyright Business Recorder, 2026