ISLAMABAD: New regulations governing refurbished medical devices in Pakistan have triggered concerns among healthcare stakeholders, with a hospital owner and former health adviser warning that inadequate implementation and oversight could expose patients to safety risks and potentially open the country to poor-quality second-hand medical equipment.
The federal government, through the Ministry of National Health Services, Regulations and Coordination and the Drug Regulatory Authority of Pakistan (DRAP), notified SRO 1450(I)/2026 on September 1, introducing regulations for refurbished medical devices with immediate effect.
According to the notification, issued under Section 24 of the Drug Regulatory Authority of Pakistan Act, 2012, read with Rule 76 of the Medical Devices Rules, 2017, refurbished medical devices will be subject to enlistment or registration by DRAP's Medical Device Board.
The regulations define a used medical device as a device that has previously been commissioned or clinically used and subsequently decommissioned or taken out of service for restoration.
Under the new framework, a refurbisher may be the original manufacturer or an authorised third-party refurbisher. The regulations require a third-party refurbisher to be authorised by the manufacturer and to comply with applicable Good Refurbishment Practices for Medical Devices.
The regulations also provide that applications for enlistment or registration may be submitted by licensed manufacturing establishments, including authorised third-party refurbishers, or by licensed importers acting as designated authorised representatives in Pakistan.
Single-use, implantable and disposable medical devices have been specifically excluded from refurbishment, while DRAP has retained the authority to prescribe an additional negative list of devices that cannot be refurbished.
However, a hospital owner and former health adviser, while commenting on the new regulatory framework, expressed serious reservations over its potential implications for patient safety.
He warned that Pakistan must not become a destination for outdated or poor-quality medical equipment discarded from other countries and stressed that any policy permitting refurbished equipment requires exceptionally strong quality assurance, traceability, technical certification, maintenance and post-market surveillance mechanisms.
He maintained that medical equipment directly involved in diagnosis and treatment cannot be treated like ordinary second-hand commercial goods because malfunctioning or inaccurately calibrated equipment could have consequences for patient diagnosis and treatment.
Questions have also been raised by the healthcare stakeholder over the legal and administrative authority through which such regulations were issued. He questioned whether the officials involved possessed the requisite statutory authority for issuance of the regulatory instrument.
However, Health Matters Media has not independently obtained a legal determination establishing that SRO 1450(I)/2026 was issued without lawful authority. The notification itself cites Section 24 of the DRAP Act, 2012 and Rule 76 of the Medical Devices Rules, 2017 as its legal basis. Any challenge to the competence, procedure or authority behind its issuance would therefore require examination by competent legal or judicial forums.
The controversy comes against the backdrop of an earlier debate within the medical-equipment industry over DRAP's approach towards refurbished and second-hand equipment. Importers had previously called for a comprehensive regulatory framework, arguing that affordable used medical equipment plays an important role in Pakistan's private healthcare sector.
Patient safety, however, remains a central consideration in regulating such equipment, particularly sophisticated diagnostic and therapeutic devices whose performance depends upon calibration, maintenance, software integrity, replacement parts and their previous service history.
The new regulations are therefore likely to face close scrutiny over how effectively DRAP verifies the origin, refurbishment standards, remaining useful life, performance and safety of equipment before allowing it to enter clinical use in Pakistan.
Healthcare stakeholders have called upon the federal health ministry and DRAP to ensure that implementation of the new regulations does not compromise patient safety and that only equipment meeting clearly defined quality and performance standards is permitted for clinical use.
They have also sought greater transparency and consultation with hospitals, biomedical engineers, medical specialists and other healthcare stakeholders before the framework is implemented on a wider scale.
