Ayesha Saba

Experts believe Pakistan’s new digital licensing system is a crucial reform to enhance investor confidence, encourage local innovation, and help position the country as a regional MedTech hub, but it needs strong oversight and sustained stakeholder engagement, reports WealthPK.

As a significant milestone under the Board of Investment’s (BOI) reform agenda, Pakistan has launched a fully digitized system for the licensing and registration of medical devices, enhancing efficiency, transparency, and cost-effectiveness in regulatory processes.

Talking to WealthPK on the condition of anonymity, an official of the BOI said the Board has emphasized the need to reduce red tape, digitize processes, and create a more investor-friendly ecosystem.

Previously, the process for licensing and registering medical devices was predominantly manual, complex, and unpredictable. There were no defined timelines, and businesses were often subjected to multiple registrations, unclear requirements, and lengthy bureaucratic procedures. This approach created substantial administrative burdens and raised compliance costs, discouraging both local entrepreneurs and foreign investors from entering the healthcare technology sector.

The official further explained that the new digital system, developed with technical support from the BOI, aims to eliminate these inefficiencies. The platform incorporates structured Standard Operating Procedures (SOPs) and aligns local regulations with global standards, including those of the USFDA and European Union.

With clearly defined timelines, a transparent application process, and digital tracking features, the reform significantly can enhance the ease of doing business in Pakistan’s healthcare sector.

He estimated that this reform will yield annual cost savings of around PKR9.43 billion, benefiting both the private sector and the regulatory apparatus. This efficiency is particularly crucial in a country like Pakistan, where the demand for modern medical devices is rising amid healthcare modernization efforts.

Talking to WealthPK, Talha Jalal, Senior Research Analyst at Pakistan Business Council, believed that such reforms are crucial for Pakistan to become a regional hub for medical technology. The streamlined system will improve investor confidence and encourage local manufacturing by making regulatory compliance less burdensome and more predictable.

By reducing regulatory barriers, the country can encourage local startups and SMEs to enter the medical device space, driving indigenous innovation. This is particularly important given the rising demand for affordable medical solutions in Pakistan’s growing population.

Talha cautioned that digital reforms alone may not be sufficient unless accompanied by robust oversight and capacity-building in the regulatory bodies. Ensuring that the new system is transparent, secure, and user-friendly will be critical to its long-term success, he added.

Additionally, he stressed the need for continuous stakeholder engagement, including training for manufacturers and regulators to adapt to the digital platform seamlessly. If implemented effectively, this initiative could serve as a blueprint for other sectors struggling with bureaucratic inefficiencies, further boosting Pakistan’s economic competitiveness.

Credit: INP-WealthPk