Pakistan drug regulator issues first rules for refurbished medical devices
Pakistan's Drug Regulatory Authority issued new regulations governing the refurbishment of medical devices that took effect immediately.
New licensing pathway established
The Medical Devices Refurbishment Regulations 2026 create a formal licensing pathway for companies repairing used equipment. Licensed manufacturers or authorized importers may submit applications using standardized forms based on device risk classification.
Registration requirements introduced
Pakistan's Medical Device Board will now enlist and register refurbished devices before they can be sold locally. Lower-risk Class A products require specific enlistment forms while higher-risk classes need formal registration.
Prohibited device categories listed
The rules bar the refurbishment of single-use, implantable and disposable devices outright. DRAP retains authority to expand this prohibited list at its discretion under the new framework.
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