Islamabad - The Drugs Regulatory Authority of Pakistan (DRAP), ministry of national health services, regulations and coordination, has notified the Medical Devices Rules, 2015, to bring the medical devices under comprehensive regulatory control for the first time in Pakistan.

The purpose of the regulation is to protect the public health by providing safe and effective medical devices, to ensure that new technology is made available for use in a timely manner and to prevent the alarming increase in deadly blood infectious diseases like Aids, Hepatitis B and C, viral hemorrhagic fever, septicaemia, etc.

Minister for National Health Services Saira Afzal Tarar said, “ After promulgation of these rules, Pakistan is now standing ahead than its neighbouring countries including India and Bangladesh with respect to regulatory mechanism specific to medical devices.

There is a grace period for gradual implementation of the rules so that lifesaving medical devices may not become short in the market.”  

The regulation will also provide public protection against unsafe, non-functional, counterfeit, sub-standard, spurious and fake medical devices and prevent the reuse of disposable devices.

Furthermore promulgation of the rules will avoid illegal route of import that keeps the exchequer devoid of taxes, thus in addition to public safety, this will also support the country’s economy.

Medical devices division of the authority in the light of Drug Regulatory Authority of Pakistan Act, 2012 (XXI of 2012) and after examination of the medical devices’ regulations of the Asian countries being harmonised by Asian Harmonisation Working Party (AHWP) and the international regulations being harmonised by International Medical Devices Regulators Forum (IMDRF) having World Health Organisation (WHO) as its official observer, framed the draft medical device rules.

These rules after exhaustive discussion in the meetings of the expert committee on medical devices and the DRAP were developed and uploaded on the website of the authority for public information and comments from the stakeholders.

Letters were also written to FBR, ministry of commerce, provincial governments, FATA, Islamabad capital territory, Azad Jammu and Kashmir, pharma bureau, Pakistan Pharmaceutical Manufacturers Association (PPMA), Pakistan Chemists and Druggists Association (PCDA), Pakistan Medical Devices Importers & Dealers Association (PMDIDA), Pakistan Medical Disposables Manufacturers Association (PMDMA), Surgical Instruments Manufacturers Association of Pakistan (SIMAP), Conformity Assessment Bodies (CABs) and WHO representative in Pakistan for comments.

The rules were redrafted in the light of the comments and the DRAP Act, 2012 and finally after vetting by the Law and Justice Division and approval by the federal government, were notified on 9th March 2015.

The whole process was very meticulous, painstaking and lot of endeavour was made for framing of these rules. This was processed in an open, consultative and transparent environment, while taking care for international regulations and local prospective.

The rules cover the procedures for registration of medical devices and conformity assessment bodies, licensing of the establishments, classification and grouping of the devices, post market surveillance, import and export, labelling requirements, advertisement and matters ancillary there to.

All Class A medical devices (low risk posing class) and establishments manufacturing, importing, exporting or selling Class A medical devices, other than those having measuring function, active or sterile, shall be regulated according to the enlistment rules to be notified by the authority.