AT the 60th World Health Assembly (WHA) in 2007, Resolution 60.29 urged member states to “draw up national or regional guidelines for good manufacturing and regulatory practices, to establish surveillance systems and other measures to ensure the quality, safety and efficacy of medical devices and, where appropriate, to participate in international harmonisation”.
Following up, the 67th WHA (2014) approved the resolution “Regulatory system strengthening for medical products”, which stresses the importance of regulations for medical devices for better public health outcome and to increase access to safe, effective and quality medical products.
In Malaysia, the Medical Device Act 2012 (Act 737) and the Medical Device Authority Act 2012 (Act 738) were passed in 2012 and subsequently gazetted in 2016. The Medical Device Authority (MDA) was established as a federal statutory agency under the Health Ministry to implement and enforce the Medical Device Act 2012, which purpose was to regulate medical devices and to facilitate the medical device trade and industry.
Malaysia, with its blooming medical industry, imports many medical devices. While it is important to regulate the market of medical devices to ensure the safety of consumers, a phenomenon of over-regulation threatens to inflate healthcare costs and reduce availability of devices in the country.
Under the Medical Device Act, items under Class A are considered to be of low risk. This includes devices used externally such as gel packs and marker pens. While the conformity assessment procedure is exempted for Class A medical devices, there is still a requirement to register them.
In comparison, the Food and Drug Administration (FDA) in the United States in 2017 released a list of Class I medical devices that would no longer be subject to pre-market notification requirements, as the process was deemed “unnecessarily and needlessly burdensome to industry stakeholders in ways that slowed innovation and patient access”.
Down south in Singapore, Class A medical devices have been exempted from product registration and are to be declared in the public online Class A database.
These countries recognise the burden of unnecessary registration and regulation and have taken the canny approach to remove the process from the system.
Perhaps unsurprisingly, complaints against front counter staff of the MDA are most common, as they are the point of contact for consumers. Issues such as lack of training, lack of coordination and also inflexibility are the challenges faced. Phone calls to the MDA are often left unanswered.
Medical suppliers have complained that responses obtained from different staff are inconsistent, leading to the suspicion that the staff are not properly trained. There were situations where consumers importing Class A medical devices for personal use were required to register those devices even though the Medical Device (Exemption) Order 2016 allows goods to be imported for personal use.
Besides that, some administrative staff in the MDA appear to have little knowledge in surgical instruments and were inflexible with the nomenclature of instruments.
Many suppliers are having a hard time trying to explain to MDA staff who have minimal knowledge in surgical instruments or devices.
Moreover, an unsatisfactory response rate is infuriating medical suppliers. Questions posed to the MDA are often ignored and not even acknowledged. We recommend that each question asked be given a reference number and all replies should be given within two weeks. Questions that cannot be answered by staff at the lower level should be escalated to a person higher up in the hierarchy.
Another common complaint is the long process it takes for the processing of registration. Many medical devices imported into Malaysia have already been registered with regulatory bodies in other countries such as the FDA and the CE (Conformité Européene of the European Economic Area).
There is a provision in circular letter number 2, Year 2014 from the MDA which states that medical devices which have gone through conformity assessment and approval for placement in the market for approval countries are only required to undergo a simpler conformity assessment process, that is through the process of verification of evidence-based compliance obtained from manufacturer of the medical device. The recognised countries include Australia, Canada, members of the European Union, Japan and the US.
Yet, the applying suppliers find themselves having to request manufacturers to provide evidence of electric currency of their product which is not required in the EU and US. While some manufacturers reluctantly comply, with additional cost, others may simply give up the Malaysian market, putting our patients at a disadvantage.
Furthermore, MDA regulations require an auditor to verify documentations of products which are already registered under the FDA or CE. This in itself is a clear example of duplication of work which adds on financial and time burden to the supplier. MDA staff should be able to perform the verification themselves!
The licensing duration is also a concern for many suppliers. At present, the establishment licence is renewed every three years whereas the product licence is renewed every five years. However, due to the long time it takes for applications to be approved, many companies find themselves having to renew their licence as early as the second year. (The MDA has, in fact, released a letter to inform suppliers to renew their establishment licence at least one year in advance!)
Any licence that has expired will be dropped from the registry list and the supplier has to reapply for a new one. This adds on to the administrative burden of the suppliers whereby they have to hire more staff to ensure that the necessary processes are followed. These additional procedures involve unnecessary costs, which are subsequently passed on to consumers in the form of higher healthcare costs.
There is definitely a need to harmonise the regulatory process to avoid unnecessary costs. We suggest extending the registration period to 10 years with the caveat that if concerns about the conduct or product of the manufacturers arise, products can be recalled and punishment such as deregistration can be instituted subject to the severity of the misdemeanour.
Medical suppliers also complain of effective medical devices from Israel not getting approval despite its use receiving the support of Muslim doctors. In our opinion, medicine should be without boundaries, and patients should not be denied treatment opportunities simply because the products originate from a country with different ideologies. Denial of access to equipment from certain countries contradicts the constitution of the World Health Organisation, which affirms that enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being without distinction of race, religion, political belief, economic or social condition.
The implementation of the Medical Device Act means doctors are no longer able to purchase surgical instruments (many are Class A surgical devices) or devices during international conferences. It is quite interesting that doctors who use surgical instruments daily are over-ruled by regulatory bodies whose assessors may not have the necessary knowledge or expertise to assess the safety and efficacy of the said equipment.
We believe not many doctors want to go to the length of getting their instruments registered as many are in small practices and do not have the time and resources to do so. This hinders patients from getting effective treatment (an efficient surgical instrument makes a difference to the efficacy of surgery or even diagnosis or management) and escalate healthcare cost (many doctors like to get surgical instruments during conferences as they are usually cheaper).
In summary, despite its good initial intention to regulate medical devices, the MDA is plagued by various issues that ultimately end up escalating healthcare costs and reducing availability of and accessibility to quality healthcare products at the expense of the people it (MDA) was created to serve.
We urge the MDA to take a cold, hard look into its system and conduct the necessary changes so as to benefit the rakyat and to carry out the purpose it was created for in the first place.
JANE H and SEAN T
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