MEDICAL devices as exports are still a relatively new area which can be expanded further as the sector is not yet saturated. However, there are many factors to consider for the new person on the block or any company looking to venture into this sector.
“If you were a start-up, I would advise you to understand all the regulations, requirement and amount of money you need to put in before you can even think about starting this business,” ETP healthcare National Key Economic Area (NKEA) associate director Fabian Bigar says.
“You should focus on quality and safety of your products first before you start churning them out. This is an industry where the moment your product is found to be defective, there goes the trust in your brand, and not only your brand but trust in Malaysian-made products.”
He advises local players unfamiliar with foreign terrains to check with agencies such as the SME Corp Malaysia, the Malaysian Investment Development Authority (MIDA) or even Biotech Corp for guidance.
Association of Malaysian Medical Industries (AMMI) chairman Hitendra Joshi says any local player with global standard compliance can leverage on government incentives and entry point projects (EPP) to venture into regional and global markets based on their core competence and products.
“Incentives are available and provided for by MIDA and SME Corp,” he notes, “(but) they have to demonstrate their capabilities in the home market first. This is where the challenge is.”
Joshi adds that there should be more opportunities for compliant local companies to supply government hospitals locally to help them build their competence and prepare them for the overseas markets.
“You are dealing with a highly regulated industry and credibility is crucial to launch your products,” says Vigilenz Medical Devices Sdn Bhd managing director Shudipta Choudhury.
“The MDB was not even set up in the early years and thus there was no avenue even to add credibility to the products, so we had to go through the expensive route of getting the ISO13485, a system certification for medical devices from a European notified body.”
Going abroad, the next thing is to get a product certification the CE mark from Europe for entry into export markets.
“To export to the European Union, every medical device needs to be CE-marked based on risk classification. The classes are 1, 2A, 2B and 3 the last being the highest risk class medical devices and our company has products certified already under class 3 since 2006, and probably the only Malaysian company at the moment,” he says.
Another player which has entered the global scene is UWC Healthcare. Its operations manager Jason Ng also notes the importance of the ISO system certification.
“For a qualified medical manufacturer, you need to have ISO13485 to show your ability to provide medical devices that meet customer and regulatory requirements,” he says.
He adds that to be a company well-received in the global arena, it needs to ensure timely delivery and good quality which can be achieved through in-house quality assurance and in-depth knowledge of local suppliers and network.
Choudhury adds: “Any new player in the market, especially if you are going to be a manufacturer, needs to know the regulatory requirements and classification for your product, so that you understand the cost implication to place the product in the market.
“Legislation in-country has to be tight to ensure that sub-standards products from Malaysia are not allowed to be sold or registered at all as this will impact the export industry itself.
“We need only one or two bad incidences to jeopardise the whole industry. Thus the vigilance system from the Health Ministry is very crucial; it has implication not only on lives but also the industry itself,” he says.