Bioniks, the Karachi-based social enterprise that builds AI-powered bionic limbs, has successfully secured medical device registration approval in Malaysia. The company announced the clearance as a new milestone in its global journey. The approval comes from the Medical Device Authority, the regulator under Malaysia’s Ministry of Health that oversees medical devices in the country, and it is comparable to registration with the Drug Regulatory Authority of Pakistan at home. Under Malaysian law, a medical device must be registered before it can be imported, exported or placed on the market, which makes the approval a necessary step before Bioniks can offer its products to patients and clinics in the country.
Registration with the Malaysian regulator is not a simple formality. Applications are filed through an online system, and a manufacturer is generally required to work through a conformity assessment body licensed by the authority and a locally licensed authorised representative. Devices are also classified by risk level, and the documentation required depends on the class. Clearing this process places Bioniks among the few Pakistani health technology companies to have completed it, and it gives the startup a recognised regulatory footing in a market that is regarded as one of the more developed in Southeast Asia for medical devices.
The approval builds on a record that Bioniks has been assembling since 2016, when it was founded by Anas Niaz and Ovais Hussain Qureshi while they were studying mechatronics engineering. The company designs and manufactures its bionic arms in Karachi and says its devices carry ISO 9001, ISO 13485 and CE marking certifications. Its arms, which are made from lightweight materials such as carbon fibre and aircraft grade aluminium and fitted with sweat and water resistant sensors, are available for users from the age of three and a half, and the company drew international attention in 2021 when it fitted a multi-grip bionic arm on a four year old boy. Bioniks has also supplied limbs to people in Afghanistan, Saudi Arabia and the United Arab Emirates, and in 2024 it won first prize among robotics startups at the AI for Good session hosted by the International Telecommunication Union. More recently, it has taken its work to conflict zones, including a mobile AI-powered limb factory for amputees in Gaza.
For Bioniks, Malaysia adds a regulated market to a list that has so far been built mostly through individual patients and humanitarian programmes. For Pakistan’s wider startup ecosystem, the approval shows that a homegrown medical technology company can meet the registration standards of a foreign regulator, an achievement that can be difficult for early stage hardware companies given the cost and paperwork involved. The company has described the registration as part of its larger plan to take affordable bionic solutions to people who need them around the world, and Malaysia now joins the countries where it can pursue that goal under a formal approval.
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