Pakistan becomes regional medical device hub with revolutionary 20-day licensing system

August 26, 2025 (MLN): Pakistan is positioning itself as a regional hub for medical device manufacturing while maintaining international quality standards, following a comprehensive government review of the Drug Regulatory Authority of Pakistan's (DRAP) groundbreaking Online Registration and Licensing System for Medical Devices.

Federal Health Minister Mustafa Kamal outlined new guidelines for accelerated approvals during his visit to DRAP headquarters yesterday.

This emphasised the country's commitment to ensuring citizen safety through digitized regulatory processes that have transformed a traditionally lengthy bureaucratic procedure into a streamlined 20-day approval system.

During his visit to DRAP headquarters, Minister Kamal outlined three key directives for the medical device sector:

"Significant progress has been made to align the medical devices regulatory system with international standards," the Minister stated, signaling Pakistan's ambition to compete globally in the healthcare technology sector.

The Minister's strategic vision is being validated by impressive early results from the digital system, inaugurated by the Prime Minister on 21 July.

The platform has already received 940 applications, with 188 approved and digital letters issued. Since its launch just over a month ago, the system has processed:

The most striking achievement of Pakistan's healthcare digitization initiative is the dramatic reduction in processing times.

The Minister praised the initiative, noting it has significantly streamlined licensing, reducing approval times from up to 24 months to just 20 days.

"Prior to this initiative, obtaining a license for medical devices took 18 to 24 months, creating unnecessary hurdles for businesspersons," Minister Kamal explained during his DRAP visit. "With the fully digitalized system, licenses are now being issued within 20 days."

The system demonstrates continuous improvement with its management dashboard parameters expanding from 10 to 23 within just one month of operation.

This enhancement ensures more vigilant monitoring and effective management of the entire regulatory process.

Minister Mustafa Kamal emphasized the broader implications of this digital transformation: "The digitization of the medical devices system has not only facilitated ease of doing business, but also has promoted domestic and foreign investment, and enabled the growth of the local industry."

The initiative aligns Pakistan's medical devices regulatory framework with international standards, positioning the country as a reliable partner in the global healthcare market.

"Digitization has improved medical standards in the country, ensured timely and easy availability of quality medical devices across Pakistan, and enhanced global confidence in Pakistan's medical devices regulatory system," the Minister stated.

The reform represents a significant step toward Pakistan's digital governance goals. Citizens can now submit applications online from their homes and obtain licenses digitally, reflecting the government's commitment to transparency, efficiency, and improved public service delivery.

This transformation from a paper-based system that took up to two years to a digital platform delivering results in 20 days represents one of the most significant regulatory efficiency gains in Pakistan's healthcare sector.

The digital system is expected to attract both domestic and foreign investment in Pakistan's medical devices sector while ensuring quality healthcare products reach citizens faster.

The continuous evolution of the platform, with regular enhancements to monitoring parameters, suggests this is just the beginning of Pakistan's healthcare digitization journey.

The successful implementation of this system positions DRAP as a modern, transparent, and people-friendly institution, setting a new standard for regulatory efficiency in Pakistan's healthcare sector.

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