VER 90 per cent medical devices used in Pakistan arrive from somewhere else.
The question is not whether that shouldchange. The question is what change requires.
Pakistan’s import dependency is often cited as evidence of failure.
The global picture tells a more nuanced story.
India despite decades of manufacturing investment and active government incentive schemes still imports between 80 and 85pc of the medical devices it uses. The United States, the world’s largest me dical device manufacturer, is simultaneously the world’s largest medical device importer.
China exports more medical devices than any other country, but still imports billions of dollars of high-end equipment annually. No country, regardless of manufacturing capability, produces every category it needs. The right question is not how to eliminate imports. It is how to build manufacturing capability in categories where Pakistan has a competitive advantage, while keeping import channels open, efficient, and fairly taxed for everything else.
The capacity to manufacture exists here. Not everywhere, not at scale but in specific product categories, in companies that have quietly built real competence with very little policy support.
What has held the sector back is not ambition. It is the absence of conditions that make manufacturing here a rational business decision rather than an act of faith.
Three things nee d to change. And they need to change together fixing onewithout the others doesn’t move the needle. The first is the cost structure. A local manufacturer pays duties on imported components, then operates in an industry where the overall tax burden makes every business decision import or produce harder than it needs to be. You cannot grow a manufacturing base on a cost structure that doesn’t reward it.
The second is the regulatory framework. The Medical Devices Rules, 2017, were modelled on Malaysia’s regulatory system a credible starting point. The problem is how they have been read and applied here; often through a pharmaceutical lens that doesn’t fit a sector built around devices. The contract manufacturing model how most of the world’s device industry operates runs into a structural wall under the current rules.
HDAP has documente d this in detail: in a white paper benchmarked against Malaysia, India, and Turkiye; in submissions to Drap and the Ministry of Health; and in a formal response to the Draft Therapeutic Goods Rules, 2026. This is not a new argument. But it is closer to resolution than it has ever been.
The third is standards. Drap issues GMP certificates to local manufacturers a meaningful credential, and a neces-sary one. But GMP, originally designed for pharmaceutical manufacturing, is not the same as ISO 13485, the international quality management standards specifically built for medical devices. India recognised this gap and has been moving to align its GMP requirements with ISO 13485. Pakistan needs to do the same. A Pakistani manufacturer whose quality system meets ISO 13485 can supply international institutions, enter export markets, and sit at the same table as any global competitor. One that meets only a pharmaceutical-origin GMP standard cannot. HDAP has said this even when it was not what some wanted to hear because the long-term credibility of Pakistani manufacturing depends on getting this right.
HDAP has signed cooperation agreements with international counterparts to improve the prospects for joint ventures and technology transfer because the appetite for that engagement exists on both sides. More than 90pc figure can change. Not through wishful thinking through a tax structure that makes local production viable, rules that reflect how this industry works, and a quality standard worth being proud of.
HDAP has put the building blocks on the table. What they need now is a policy environment willing to build with them. E