Laws on healthcare devices in the works

Sunday April 6, 2008
Laws on healthcare devices in the works
I REFER to the letter, The need to protect consumers of healthcare services (Your Say, StarMag March 23).

In that letter, Ms Ranjit Kaur, president of the Malaysian Breast Cancer Council, called upon the Ministry of Health (MOH) to protect the consumers by regulating medical devices and non-evidence-based approaches.

The MOH is well aware of the issues associated with medical devices in this country. These include, among others, the following:

1. The absence of pre-market controls to assess safety, effectiveness, and quality of medical devices prior to making these devices available on our market.

2. Inadequate information to guide the public and health professionals in making informed choices about medical devices that can be used safely and effectively to diagnose and treat illnesses.

3. The absence of a formal post-market reporting system to identify and monitor medical devices with problems in the market for follow-up action.

The MOH recognises the need to develop and implement a medical device regulatory system to address and manage these and other issues associated with medical devices.

In 2005, a proposal to develop and implement such a system in Malaysia was presented by the MOH to the Cabinet, which agreed to the proposal.

The proposed system is aimed at protecting the public as well as ensuring the safety of such devices, while, at the same time, facilitating trading activities to allow for the timely availability of beneficial new technologies to the medical community and the public.

The regulatory system encompasses the following components:

1. Medical Devices Act and its subsidiary legislations to provide legislative support for the medical device regulatory system.

2. An appropriate agency to implement and enforce the regulatory system.

3. Appropriate infrastructure and mechanisms for effective and efficient implementation of the regulatory system.

4. Medical Devices Registration and Surveillance/Vigilance System.

The ministry is currently in the midst of developing a medical device regulatory system based on international practices and standards.

As an initial step towards a regulated environment, the ministry initiated in 2006 a voluntary registration scheme for companies dealing with medical devices in Malaysia. The ministry has also started a reporting system for problematic devices on the market.

Voluntary registration of medical device products will start by the middle of this year.

With the implementation and full enforcement of the regulatory system, only medical devices that have met essential safety and performance requirements will be permitted in the market.

At the same time, the MOH has been actively conducting health technology assessments and technology reviews of new technologies since 1995. Health technology assessments are the systematic evaluation of the properties, effects or other impacts of technology, using evidence-based processes.

More importantly, this systematic evaluation will be benchmarked with international health technology assessment groups such as the International Networking Agencies of Health Technology Assessment, etc.

The MOH has also developed evidence-based Clinical Practice Guidelines (CPGs) since 2001. This is to ensure technologies used in our facilities are safe, cost-effective, and evidence-based.

We have so far produced 42 health technology assessment reports, 133 technology review reports and 43 evidence-based CPGs. All these reports can be accessed at the MOH website at moh.gov.my.

We also update the CPGs from time to time. A version of the CPG for patients has also been initiated.

With all these initiatives, we hope consumers will not only have access to evidence-based information on new technologies and practices but also that all medical devices introduced in this country will be safe and of high quality, and used only after stringent appraisal based on scientific evidence.

Tan Sri Dr Mohd Ismail Merican

Director General of Health

Malaysia