Cabinet approves new medical devices rules

Policy will help regulate and provide quality medical devices to people

ISLAMABAD: The trade and supply of medical devices would be regulated for the first time in the country after a new policy takes effect across the country.

Medical Devices Rules 2017, approved by the federal government in the cabinet meeting held on December 26, will come into effect when the Drug Regulatory Authority of Pakistan notifies them.

Every type of medical device including coronary stents will also be regulated under these rules. The trade of stents had created much hullabaloo when the investigation agencies unearthed a scam that revealed inserting fake, expired cardiac stents in patients at exorbitant rates.

Unregulated sector

“Since last 70 years, trade of medical devices was not regulated in the country except for few under Drugs Act, 1976,” said DRAP CEO Aslam Afghani.

There were a lot of complaints and people were at high risk of being sold C-quality at the rate of A-quality due to unregulated business and practice of selling and implanting medical devices, he said. The market was flooded with all types of fake, spurious, and expired medical devices and patients were being charged at exorbitant prices.

However, with the enactment of new rules, these devices would be registered and regulated and violators could be penalised, Afghani said.

Consultative process

Industry sources reminded that when cardiac stents scam hit the headlines early this year, the Prime Minister’s Office under the orders of Supreme Court started a consultative process with stakeholders of medical devices and biotechnology.

Earlier, Medical Devices Rules, 2015 could not be implemented due to lack of third party assessment by the Conformity Assessment Bodies (CABs) after registration with DRAP or Pakistan National Accreditation Council (PNAC).

However, as per Medical Devices Rules, 2017, a Medical Devices Board will perform assessment and evaluation. The board will comprise representatives of federal and provincial governments along with experts from the field of medicine, biomedicine, software, electromechanical engineering and pharmacy.

To ease the process of registration of medical devices, the fee structure has been revised in the rules. 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 classification and grouping of medical devices has been harmonised with international guidelines of WHO, International Medical Devices Regulators Forum (IMDRF) and Asian Harmonisation Working Party (AHWP).

A new cardiac stent registry has been uploaded on the DRAP official website for online registration of cardiac stents. Similarly the registry has also been established for companies seeking establishment licence. 

Published in The Express Tribune, December 28^th, 2017.