Environmental Scan 2017: Human Capital Issues within the Medical Devices Sector
2 Medical Devices Industry in Malaysia
The Malaysian medical device landscape has seen positive growth over the years with rapid
technological advancement, growing demand and a booming private healthcare sector driving
the growth of the local medical device landscape. Ma laysia’s ideal geographic location combined
with world class infrastructure has also supported the positive growth over the years. In addition
to this, MIDA has also played a major role in further strengthening the medical devices landscape
in Malaysia. One of its focus area is to focus on medical devices which are imported at present.
Hence, MIDA is promoting medical devices such as electro-medical equipment and
cardiovascular devices by establishing the Medical Device Investment Advisory Panel (MDIAP).
MDIAP aims to facilitate Malaysian companies in becoming more competitive within the
international medical devices arena. Some of the other strategies which MIDA and other related
agencies have adopted in strengthening the medical devices industry include:
Moving towards the manufacturing of higher end range medical devices
Further promoting foreign investments within the industry
Capitalising on the support industries
Promotion of new related courses to enable a highly skilled workforce
Some of the key regulators and industry associations associated with the medical devices industry
is as shown in Table 2-1.
Table 2-1: List of regulatory and industry associations
Agencies
Medical Device Authority
(MDA)
Description
General medical and IVD devices are regulated by the MDA
which functions under the Ministry of Health. The role of MDA
encompasses on the following tasks; registering medical
devices (all classes), issuing licenses, inspecting facilities
(establishments), monitoring medical devices already on the
market, monitoring operation and usage of medical devices
(including disposal), laboratory testing, and drafting laws and
standards.
One of the key act which comes under the MDA is the Medical
Device Act, which came into effect on the 1st of July 2013. The
Act requires all medical devices sold in the country (both
manufactured and imported) to be registered. All
manufacturers, importers and distributors are also required to
register and obtain permits/licenses from the Ministry of
Health to operate in the country. The aim of this regulation is
to protect patients from substandard or inferior quality
products.
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