Medical devices rules notified

Islamabad
The Drug Regulatory Authority of Pakistan (DRAP) has notified the Medical Devices Rules 2015, bringing medical devices under comprehensive regulatory control for the first time in Pakistan.
The purpose of the regulation is to protect public health by providing safe and effective medical devices, to ensure that new technology is made available for use for patients in a timely manner, and to prevent the alarming increase in deadly blood-borne infectious diseases like Aids, Hepatitis B and C, Viral hemorrhagic fever, septicemia, etc.
“After promulgation of these rules, Pakistan is now standing ahead of its neighboring 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 life-saving medical devices do not become short in the market,” Minister for National Health Services Saira Afzal said.
The regulation will also provide 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, the measure will also support the country’s economy.
The rules are said to have been developed and uploaded after exhaustive discussions in meetings of the expert committee on medical devices and DRAP, and were uploaded on the website of the Authority for public information and comments from 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, Pakistan Chemists & Druggists Association Pakistan Medical Devices Importers and Dealers Association, Pakistan Medical Disposables Manufacturers Association, Surgical Instruments Manufacturers Association of Pakistan, Conformity Assessment Bodies (CABs) and WHO representative in Pakistan, for comments,” a press release of the ministry informs.
The rules were redrafted in the light of the comments and DRAP Act 2012, and finally after being vetted by the Law and Justice Division and approved by the federal government, were notified on March 9.
The rules cover procedures for registration of medical devices and conformity assessment bodies, licensing of establishments, classification and grouping of devices, post-market surveillance, import and export, labeling requirements, advertisement and matters ancillary thereto.