Government approves new medical devices rules

islamabad – The federal government approved new medical devices’ rules for Ministry of Health to regulate and control the flow of expired and spurious devices in the market, a press statement said.

The statement issued by the Ministry of National Health Services said that the federal cabinet had taken the decision following Supreme Court orders, which had directed for initiating a consultative process with all stakeholders to make and implement new rules on use of medical devices.

The new rules include regulations governing manufacturing, import and export of quality medical devices in the country while ensuring public safety.

The statement said that under the Medical Devices Rules 2017, role of assessment and evaluation of medical devices would be performed by a Medical Devices Board.

The MDS will comprise officials of the federal and provincial governments along with experts in the fields of urology, nephrology, radiology, biomedical, software or electromechanical engineering, general, orthopaedic and cardiovascular surgery, interventional cardiology, pathology, medical technology and pharmacy with background in manufacturing, quality control and hospital pharmacy.

Under the new rules, the process of registration of medical devices has been relaxed while the fee structure has also been revised.

Technical documentation requirements for registration of medical devices have been minimised, if imported from reference countries including USA, European Union, Japan, Canada and Australia, the statement said.

Classification and grouping of medical devices has been harmonised with international guidelines of the World Health Organisation (WHO), International Medical Devices Regulators Forum (IMDRF) and Asian Harmonisation Working Party (AHWP).

Since the last 70 years, the medical devices were not regulated in the country except for few under the Drugs Act 1976. There were lot of complaints and public were at high risk due to non-regulation of medical devices, the statement added.

Earlier, Medical Devices Rules 2015 were notified on March 9, 2015 but could not be implemented as envisioned due to lack of third-party assessment to be done by the Conformity Assessment Bodies (CABs) after registration with the Drug Regulatory Authority of Pakistan (DRAP) or Pakistan National Accreditation Council (PNAC).

Since the CABs could not develop as required, the implementation of rules posed a serious handicap which needed to be remedied to continue medical device supplies to hospitals for patient needs, without interruption, the statement said.

In this regard, a  committee was constituted by the Prime Minister Office, headed by Additional Secretary Ministry of National Health Services, Regulation and Coordination, and comprising representatives from the PM Office, provinces, associations of medical devices, including Pakistan Chemist and Druggist Association, Healthcare Devices Association of Pakistan, Pharma Bureau, Pakistan Diagnostic Association, Pakistan Cardiac Devices Importer Association and the Drug Regulatory Authority of Pakistan.

 The stakeholders were continuously complaining about implementation prospects of these rules.

A new cardiac stent registry has been uploaded on the Drug Regulatory Authority of Pakistan  website for online registration of cardiac stents. Similarly, the registry has also been established for companies seeking establishment license.


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