Addressing Disparities in Medical Device Export Regulations: A Call for Reciprocal Arrangements and Local Industry Support

PERANTIM President putting up his case to YB Rafizi Ramli Minister of Economy in the recent Sesi Libat Urus New Deal for Business (NDFB) at Hotel Palm Garden Putrajaya.

  1. Where is the reciprocal arrangement in all the FTAs if Malaysian Medical Devices Exporters have to go through 2 year of rigorous audit regime and be subjected to up to RM0.5M audit fee per product family to enter European Market when they can just walk in our Authority Office, register , pay nominal fee and start selling in our market after 2weeks?
  2. We need to nurture new medical devices manufacturers & exporters as the country really lacks new players. We have huge opportunities to do this as stat shows we imported RM8.27Billion medical devices in 2023. Furthermore, last year PMX announced highest ever KKM budget at RM42.3Billion. Granted that 60%-70% was meant for managemnt, salary, maintenance etc. Yet there is good portion for business development for the local player if good structured program can be formulated.

In 2021 , Indonesian Presiden mandated the govt to stop importing meddev if they can be manufactured locally. This has spurred rapid meddev manufacturing activities locally. Malaysia can learn a thing or two from this.

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