KARACHI: Pakistan's Drug Regulatory Authority (DRAP) has issued a new regulatory framework governing the refurbishment of medical devices, creating for the first time a formal licensing pathway for companies that repair, restore or recondition used equipment for continued clinical use.
The Medical Devices (Refurbishment) Regulations, 2026, were notified through S.R.O. 1450(I)/2026 and took effect immediately. DRAP issued the regulations under Section 24 of the Drug Regulatory Authority of Pakistan Act, 2012, and Rule 76 of the Medical Devices Rules, 2017, with prior approval from the agency's Policy Board.
Under the new rules, Pakistan's Medical Device Board (MDB) will be responsible for enlisting and registering refurbished devices before they can be sold or used in the country.
Applications may be submitted by licensed manufacturers acting as third-party refurbishers authorized by a foreign manufacturer, or by importers serving as an authorized representative in Pakistan.
The regulations bar refurbishment of single-use, implantable and disposable devices outright, and give DRAP authority to expand that prohibited list at its discretion.
Companies seeking approval must file applications using one of four new standardized forms, depending on the device's risk classification. Class A devices, generally lower-risk products, require enlistment through Form-1R for local manufacture or Form-2R for imports.
Higher-risk Class B, C and D devices require formal registration through Form-3R or Form-4R. Approved devices receive certificates in the format of Form-5R or Form-6R, valid for five years unless suspended or canceled.
The rules impose a lengthy set of technical and quality obligations on refurbishers. Facilities must maintain a certified quality management system covering refurbishment operations and follow new "Good Refurbishment Practices for Medical Devices" guidelines still to be issued by the Authority.
Every refurbished device must carry a label prominently marked "Refurbished," along with a new catalog or code number distinct from the original product, the refurbisher's name and license number, and both the original manufacturing date and refurbishment date to ensure traceability.
Refurbishers must also compile a technical file for each device model, including risk management documentation, software verification records where applicable, and traceability data on replaced parts, along with a declaration of conformity, a certificate of analysis, and, for any radiation-emitting equipment, calibration certification from the Pakistan Nuclear Regulatory Authority before final release.
The regulations distinguish refurbishment from "remanufacturing," defined as changes significant enough to alter a device's original performance, safety specifications or intended use. Remanufactured devices are explicitly excluded from the new framework and remain subject to standard manufacturing rules.
Local refurbishers face additional operational requirements, including employing qualified technical staff, maintaining calibrated testing equipment and service workshops, and guaranteeing long-term availability of spare parts and after-sales support.
DRAP retains broad enforcement powers under the regulations. The MDB must issue a show-cause notice before suspending or canceling any enlistment or registration, giving holders 15 days to respond in writing.
Grounds for suspension or cancellation include safety concerns, noncompliance with conditions, fraud in obtaining a license, or a determination that action is needed in the public interest.
Fees for enlistment, registration and related activities will be charged under DRAP's existing 2022 Fee and Levy Rules and are non-refundable once deposited, the notification states.
