Rules to regulate manufacturing, import of medical devices notified

KARACHI: The Drug Regulatory Authority of Pakistan (DRAP) has notified upgraded “Medical Devices Rules, 2017” to enforce stricter regulation and licensing of local manufacturing and import of the items/products, which if not checked for proper safety/quality could prove to be a danger to the users.

The new rules are aimed at improving the health of the sector that deals in any apparatus, appliance, software, material, or other article used specifically for diagnostic and/or therapeutic purposes.

Instances range from simple devices such as tongue depressors, medical thermometers, and disposable gloves to advanced devices such as computers which assist in the conduct of medical testing, implants, prostheses, etc.

The main highlight of the new rules is the constitution of a Medical Devices Board (MDB), which will, henceforth, assess and evaluate the products/items that fall under this category.

“The board will comprise federal/provincial officials, experts from the fields of urology, nephrology, radiology, biomedical, software or electromechanical engineering, general medicine, orthopedic and cardiovascular surgery, interventional cardiology, pathology, medical technology, and pharmacy,” the official document said.

It added that experts, having vast experience in manufacturing, quality control, and hospital pharmacy would be appointed on the board.

Under the new rules, the document said, it is mandatory for the applicants, who aspire to acquire a license to manufacture medical devices, to have suitable premises for the operations employing pharmacy and biomedical engineering professionals to supervise the process.

“The manufacturing facility must be adequately equipped with precautionary features for safeguarding workers’ health. The building must also have all the measures to avoid industrial accidents and diseases,” the document said.

The document said same rule applied for the applicants seeking an establishment license to import and sell medical devices. “They must be in possession of a fit structure with adequate arrangements. Also, the import, storage, distribution, and sales operations should be conducted under the supervision of at competent technical staff,” it added.

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 minimised, if imported from reference countries including USA, European Union, Japan, Canada and Australia,” it said.

Also, as per new rules, classification and grouping of medical devices has been harmonised 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 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.

To overcome this problem, a committee, was constituted by the Prime Minister’s Office. It was headed by additional secretary ministry of national health services, regulation and coordination, and comprising representatives from the premier’s office, provinces, associations of medical devices etc.