ISLAMABAD: For the first time in Pakistan, medical devices such as cardiac stents, valves and pacemakers are coming under comprehensive regulatory control after the notification of Medical Device Rules (MDR) 2015.

According to the rules, a Medical Device Board will be established which would be responsible for the registration of Conformity Assessment Bodies (CABs), licensing of manufacturing units and registration of medical devices. The board will also regulate import and export of these devices.

CABs are companies which have expertise in judging quality parameters of medical devices. Manufacturers register their products with CABs to prove compliance with international standards.

Ministry of National Health Services (NHS) Secretary Ayub Sheikh told Dawn the rules have been promulgated with immediate effect however practical implementation is likely to take some time.

An official of the ministry of NHS said the purpose of the regulatory body is to protect public health by providing safe and effective medical devices. It would also help in countering the alarming increase in blood born infectious diseases such as Aids, hepatitis B and C, viral hemorrhagic fever and septicemia, he said.

Pakistan to become first country in South Asia to regulate medical devices

“The regulation will protect people from unsafe, non functional, sub-standard, spurious and fake medical devices and prevent the reuse of disposable devices. Moreover promulgation of the rules would prevent illegal import, helping in ensuring safe devices and income from import duties,” he said.

The official said that the Medical Device Rules have been made in accordance with guidelines by the World Health Organization (WHO). Moreover, health experts and other stake holders including federal ministries, health departments and private medical sector were consulted, he said.

“The rules cover procedures for registration of medical devices and CABs, licensing, classification and grouping of the devices, post market surveillance, import and export, labeling requirements, advertisement and other issues,” he said.

The promulgation of these rules has put Pakistan ahead of its neighbours including India and Bangladesh, with regards to regulatory mechanisms for medical devices. However, the rules for regulation of medical devices were introduced by the United States as early as 1976.

A Drug Regulatory Authority of Pakistan (Drap) official, requesting anonymity, said that over one million medical devices which include spectacles, cardiac stents, pacemakers, laparoscopy machines, laboratory and clinical machines, machines used in manufacturing of drugs would be regulated through these rules.

“Substandard medical devices can give wrong readings and test results while poor quality devices put inside the body such as cardiac stents, valves, pacemaker and plates used to join broken bones can cause infection and death,” he said.

According to the notification, dated March 9, there is a grace period for gradual implementation of the rules so that there is no shortage of life saving medical devices in the market.

Companies have been instructed to register their products with the CABs within six months. High risk (class D) devices will be regulated after one year, high moderate risk devices (class C) in 18 months, moderate low risk (class B) and low risk (class A) will be monitored after two years.

Drap Chief Executive Officer Dr Muhammad Aslam told Dawn that surgical instruments fall in class A, syringes in class B, instruments used on or under the skin fall in class C and devices which are put inside the body such as cardiac stents fall in class D.

“At the moment anyone travelling from abroad can bring medical devices and supply them to the hospitals. These devices may be substandard but Drap never receives information about the quality of these products. Only proper importers and manufacturers should be allowed to import devices,” he said.

The Drap chief further said Pakistani companies exporting medical devices would also need to be registered.

He said that the Medical Device Board will be established soon, with a director as head of the board and representation of all stakeholders. “However, a final decision will be made in the meeting of the policy board,” he said.

Since 1976, the Ministry of Health was only regulating pharmaceutical drugs and a limited number of medical devices such as syringes, stents, and catheters were also registered as drugs.

The need for regulating medical devices was felt by the government in 1996 when it was realised that reuse of syringes was causing diseases such as hepatitis to spread.

When the government attempted to regulate the syringes market, manufacturers obtained a stay order from courts which remained in place, for over a decade.

Published in Dawn March 20th, 2015

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