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Market Information
Malaysia’s healthcare expenditure was a total of RM78.2 billion in 2021 and is forecasted to steadily increase by 7.7% annually from 2023 to 2027.
Market Trend: The healthcare insurance market is projected to grow from $3.26 Bn in 2022 to $5.94 Bn by 2030,
Malaysia’s medical equipment market is expected to be worth US$2.0 billion in 2022, with a CAGR of 7.5%.
MDA, a federal statutory agency operating under the Ministry of Health Malaysia, holds the responsibility of overseeing the Malaysian medical device industry. Its mandate involves the enforcement of the Medical Device Act 2012 (Act 737) and aims to ensure public health and safety concerning medical devices while fostering the growth of the medical device trade and industry.
Medical Device Regulation
Medical Device Authority (MDA), under the MOH.
Regulation of medical devices done under the Medical Device Authority Act 2012 (Act 738) and its Medical Device Act (Act 737)
Classification, Fees, Timeline
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Product Registration Routes
Class A (Online submission to MedC@St2.0+)
Submit application directly to MDA
Class B, C, D (Online submission to MedC@St2.0+)
Submit application to a local accredited conformity assessment body (CAB) before submission to MDA
Useful Information
Validity of License: 5 years
License transfer: License transfer process is possible through a process called “Change of Ownership”.
Importer and Distributor: Both must obtain establishment licence.
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