KUALA LUMPUR, Oct 17 (Bernama) -- The Malaysian Standard Halal Medical Device certification should be strengthened to be widely accepted and recognised globally, the Malaysia Medical Devices Manufacturers Association (PERANTIM) proposed.
PERANTIM president Johari Abu Kasim said as one of the first countries in the world to introduce such certification, Malaysia could use it as a reciprocal negotiating tool for countries that have signed Free Trade Agreements (FTAs) with Malaysia.
"Currently, medical devices from Malaysia face difficulties penetrating the European and American markets, the two largest markets, due to registration challenges to meet complex foreign standards and high auditing costs," he told Bernama recently.
Johari said, in contrast, registered European and American medical device manufacturers can obtain certification from the Medical Device Authority (MDA) under the Ministry of Health within 14 days to market their products in Malaysia.
According to him, Malaysian companies must get the Conformity of European (CE) certification under the Medical Devices Regulation (MDR) and the approval of the US Food and Drug Administration, which can fetch over half a million ringgit or approximately US$150,000 for a single medical device. On top of this, there is a two-year waiting period for the audit process.
"Where is the reciprocity in this case? It would be beneficial if countries in Europe accept Malaysia's MDA certification and halal medical device certification as one of the requirements for their products to enter Malaysia, just as we are mandated to comply CE MDR to penetrate their market," he said.
In 2019, the Department of Standards Malaysia (JSM) developed a halal certification for medical devices, coded MS 2636:2019, aimed at ensuring that medical devices produced by manufacturers comply with Syariah requirements in all aspects.
Dental floss, eye lubricant, equipment and supplies used in dialysis procedures, surgical sutures, and wound cleansers are some examples of products certified halal.
Johari stated that halal products command a vast global market, adding that Malaysia should take advantage of the international medical device industry, which is expected to reach nearly US$800 billion by 2030.
In addition, he said that Malaysia could leverage its position as the ASEAN chair next year to further promote this halal certification in the Southeast Asian region.
"Halal medical devices open up at least 50 per cent of the global market in halal medical devices, halal tourism, and halal logistics. We can also collaborate with OIC countries to adopt halal certification as a global standard," he said.
According to Johari, PERANTIM is working closely with industry stakeholders to bring European medical device certification agencies to Malaysia and establish their branches via joint-venture efforts to facilitate, expedite, and reduce the audit certification costs for local medical device manufacturers planning to enter the European market.
He said this international collaboration could be realised early next year, significantly boosting the export of Malaysian-made medical devices to Europe and creating numerous business opportunities and training prospects for university students.
-- BERNAMA
