The domestic medical device market in Malaysia is forecasted to be worth US$2.0billion in 2022, with a Compound Annual Growth Rate (CAGR) of 7.5% between 2018 and 2022F according to a report published by KPMG based on figures sourced from Fitch Solutions reports.
Malaysia medical manufacturers also supply 60% of the world market for medical gloves and 80% for catheters.
In terms of domestic consumption of medical devices, Malaysia currently imports around 95% of its need in medical devices.
Overall, the market attractiveness for medical device companies considering entering the Malaysian market is high in terms of robustness of the regulatory network, application of digitalized distribution and centralization of procurement process.
Malaysia has attracted some well-known Multinational Corporations including B. Braun who has it’s APAC regional headquarters and a Centre of Excellence for Intravenous Access (IA) in Penang, Malaysia.
The medical devices industry is expected to impact positively on the Malaysian economy as it transitions to manufacturing more higher value-added and technologically advanced products, such as cardiac pacemakers, stents, orthopaedic implantable devices, electro-medical, therapeutic, and monitoring devices.
Regulatory authority and laws governing medical devices in Malaysia
Medical devices and IVDs are regulated by the Medical Device Authority (MDA). It is a federal statutory agency under the Ministry of Health (MoH) Malaysia. The main objectives of the Act are to address public health and safety issues related to medical devices and to facilitate medical device trade and industry. The MDA implements and enforces the Medical Device Act 2012 (Act 737) as mandated for under the Medical Device Authority Act 2012 (Act 738).
Malaysia’s healthcare system
Malaysia has a two-tiered healthcare system: a government-based universal healthcare system and a highly effective private healthcare system (either fully self-funded out-of-pocket and/or private insurance). The government allocated US$7 billion to the public healthcare sector in 2019, an increase of 7.8 percent from 2018, almost 10 percent of the national budget.
With a modestly high per capita GDP, demand for private healthcare services in Malaysia is expected to continue to grow beyond current use by predominantly by the upper-middle income to affluent segment of the population.
According to Dezan Shira and Associates, the healthcare sector is expected to grow to US$30 billion by 2027, fueled by increasing demand for healthcare services from an ageing population, rising affluence, and increasing life expectancy.
Malaysia has some of the lowest medical fees in the world (some 40% lower than the US and UK) with the government subsidizing up to 98% of healthcare costs.
Malaysia is also considered a potential health service hub in ASEAN despite fierce competition from its more established neighbours of Singapore and Thailand.
Malaysia is becoming known as a specialist provider for cardiology treatments as it aims to become the preferred destination for medical tourism in ASEAN.There are over 30 advanced heart treatment centres including the National Heart Institute which earlier this year was the first hospital outside of the USA to implant the world’s tiniest pacemaker, the Micra AV developed by Medtronic. For more information: https://www.aseanbriefing.com/news/malaysias-healthcare-sector-a-rising-giant-in-asean/
The Association of Malaysian Medical Industries (AMMI) was formed in 1989 and represents manufacturers; suppliers of raw materials and services to the medical devices manufacturing companies; as well as importers and exporters of medical devices. The AMMI currently has 71 member companies. For more information: https://ammi.com.my/about-us/about-ammi/
The Malaysia Medical Device Association (MMDA) was formed in 2005 and its members include local manufacturers, local authorised representatives, importers, suppliers, distributors, multi-national corporations and service providers involved in the distribution and sales of medical devices and related healthcare products and equipment within Malaysia. For more information: http://www.mmda.org.my/main/3180/index.asp?pageid=159342&t=about-us
General economic and demographic statistics
Population of 32.7 million in 2020
People aged 65 and over in 2020 constituted around 7% of the population, with the country moving towards an ageing population by 2030
Particular health concerns are obesity and diabetes; in 2019 Malaysia ranked sixth in the Asia Pacific region and the top country within Southeast Asia for both obesity and diabetes. An alarming seven million adults, both diagnosed and undiagnosed, are estimated to be affected by diabetes in Malaysia by 2025
Gross Domestic Product (GDP) growth is calculated to be 7.8% in 2021 and forecasted to be 5% in 2025 according to the International Monetary Fund
Unemployment rate of 4.8% in 2020 which was higher than predicted due to the COVID pandemic.
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