DRAP notifies rules to regulate manufacture, import of medical devices

KARACHI: Drug Regulatory Authority of Pakistan has notified Medical Devises Rules, 2017 to regulate licensing of local manufacturing as well as import of medical devices.

Under the Medical Devices Rules 2017, role of assessment and evaluation of medical devices would be performed by a Medical Devices Board (MDB).

The MDB 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.

In order to have a medical device manufacturing license, the applicant must be in possession of a suitable premise for the manufacturing operations employing pharmacy and bio-medical engineering professionals to supervise the process.

The premise must have adequate precautions for safe-guarding the health of workers including measures to avoid industrial accidents and diseases.

Applicants seeking grant of establishment license to import and sell medical devices must be in possession of a suitable premise with adequate arrangement while import, storage, distribution and sale should be conducted under the supervision of at competent technical staff.

Under the 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 minimized, if imported from reference countries including USA, European Union, Japan, Canada and Australia.

Classification and grouping of medical devices has been harmonized with international guidelines of the World Health Organization (WHO), International Medical Devices Regulators Forum (IMDRF) and Asian Harmonization 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.

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.

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.

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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