Medical Device/Medical Technology (MedTech) Companies/Industry in Malaysia
- Maple Chieng
- Feb 4
- 7 min read
Malaysia is said to be the largest market for medical devices in the ASEAN region with an estimated total market size of USD1.8 billion[1].
The New Industrial Master Plan 2030 outlines 21 sectors that the government of Malaysia is eyeing for further development, with the aim of creating 3.3 million high-value jobs by 2030 to improve the rakyat’s quality of life. Of these sectors, five are deemed “priority”, amongst others, medical devices[2].
Malaysia offers significant opportunities for companies in medical device/MedTech space which require navigation through various laws and regulations governing medical device/MedTech companies/industry in Malaysia while offering business solutions-oriented and practical advice to accelerate business’ growth.
(1) Laws and regulations
(a) Establishment Licence issued by the Medical Device Authority, Ministry of Health
No establishment (either a manufacturer, an authorized representative appointed by a foreign manufacturer, an importer, or a distributor) shall import, export or place in the market any registered medical device unless it holds an establishment licence granted under the Medical Device Act 2012 (“MDA”).
“Medical device” means any instrument, apparatus, implement, machine, appliance, implant, in-vitro reagent or calibrator, software, material or other similar or related article intended by the manufacturer to be used, alone or in combination, for human beings for the purpose of:
(i) diagnosis, prevention, monitoring, treatment or alleviation of disease;
(ii) diagnosis, monitoring, treatment, alleviation of or compensation for an injury;
(iii) investigation, replacement or modification, or support of the anatomy or of a physiological process;
(iv) support or sustaining life;
(v) control of conception;
(vi) disinfection of medical device; or
(vii) providing information for medical or diagnostic purpose by means of in-vitro examination of specimens derived from the human body, which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but that may be assisted in its intended function by such means, and
any instrument, apparatus, implement, machine, appliance, implant, in-vitro reagent or calibrator, software, material or other similar or related article, to be used on the human body, which the Minister may, after taking into consideration issues of public safety, public health or public risk, declare to be a medical device by order published in the Gazette.
Any establishment that contravenes this requirement commits an offence and shall, on conviction, be liable to a fine not exceeding RM200,000 or to imprisonment for a term not exceeding three (3) years or to both.
(b) Medical Device Registration Certificate issued by the Medical Device Authority, Ministry of Health
Pursuant to the MDA, no medical device shall be imported, exported or placed in the market unless the medical device is registered under the MDA. The application for registration of medical device is to be done by a local manufacturer or an authorized representative appointed by a foreign manufacturer.
Any person that contravenes this requirement commits an offence and shall, on conviction, be liable to a fine not exceeding RM200,000 or to imprisonment for a term not exceeding three (3) years or to both.
(c) Restrictions on Advertising and Labelling
The MDA prescribes that:
(i) No person shall advertise a medical device unless the medical device has been registered and complied with the requirements of the MDA.
(ii) No person shall make any misleading or fraudulent claims in respect of a medical device in any advertisement.
Any person that contravenes either of the provisions commits an offence and shall, on conviction, be liable to a fine not exceeding RM300,000 or to imprisonment for a term not exceeding three (3) years or to both.
The Medical Device (Advertising) Regulations 2019 (“Advertising Regulations”) prescribes that no person shall advertise any registered medical device without the approval from the Medical Device Authority, Ministry of Health. Any person that contravenes the above provision of the Advertising Regulations commits an offence and shall, on conviction, be liable to a fine not exceeding RM200,000 or to imprisonment for a term not exceeding two (2) years or to both.
Medical Device Regulations 2012 (“MDR”) is made under the MDA to regulate, among others, provisions on labelling. The MDR provides that the label shall not contain any statement to the effect, whether direct or indirectly, that the placement in the market, or usage or operation of the medical device is being promoted or endorsed by the Medical Device Authority or the Ministry of Health or any of its organisational bodies. A manufacturer that contravenes this requirement commits an offence and shall, on conviction, be liable to a fine not exceeding RM10,000 or to imprisonment for a term not exceeding three (3) months or to both.
(d) Manufacturing Licence issued by the Ministry of Investment, Trade and Industry (“MITI”)
The Industrial Co-ordination Act 1975 (“ICA”) requires manufacturing companies with shareholders’ funds of RM2.5 million and above or engaging 75 or more full-time paid employees to apply for a manufacturing licence from the MITI. Failure to comply with the licensing requirements under the ICA will constitute an offence which is punishable on conviction by a fine not exceeding RM2,000 or to a term of imprisonment not exceeding six (6) months and to a further fine not exceeding RM1,000 per day during which the default continues. Application for manufacturing licence is to be submitted to the Malaysian Investment Development Authority (MIDA), an agency under MITI in charge of the promotion and coordination of industrial development in Malaysia.
The licensing officer may also in his discretion revoke a licence if the manufacturer to whom a licence is issued:
(i) has not complied with any condition imposed in the licence;
(ii) is no longer engaged in the manufacturing activity in respect of which the licence is issued; or
(iii) has made a false statement in his application for the licence.
The licensing officer may also withhold or suspend the revocation of the licence if he is satisfied that the act or omission on the part of the manufacturer under the above situations was due to some cause beyond his control and there is a reasonable prospect of such act or omission being remedied within such period as the licensing officer may direct.
Foreign investors can now hold 100% of the equity in all investments in new projects, as well as investments in expansion/diversification projects by existing companies[3].
(e) Business Premise Licence and Signboard Licence issued by the relevant local authority
The Local Government Act 1976 (“LGA”) is enacted to revise and consolidate the laws relating to local government in Peninsular Malaysia. Every licence or permit granted by the local authority shall be subject to such conditions and restrictions as the local authority may think fit and shall be revocable by the local authority at any time without assigning any reason therefor.
Every person to whom a licence has been granted shall exhibit such licence at all times in some prominent place on the licensed premises and shall produce such licence if required to do so by any officer of the local authority authorised to demand the same.
Any person fails to exhibit or produce such licence on the licensed premises shall be liable to a fine not exceeding RM500 or to imprisonment for a term not exceeding six (6) months or to both.
The LGA governs the by-laws of the respective local authorities, amongst others, the Licensing of Trades, Businesses and Industries (Federal Territory of Kuala Lumpur) By-Laws 2016 (“Business By-Laws”) and the Advertisements (Federal Territory) By-Laws 1982 (“Advertisement By-Laws”).
Pursuant to the Business By-Laws, a business premise licence is required from Kuala Lumpur City Hall (Dewan Bandaraya Kuala Lumpur) (“DBKL”) for a person to use any premise for operating any business activity.
The Business By-Laws further states that any person who contravenes any provisions of the Business By-Laws shall be guilty of an offence and shall, on conviction, be liable to a fine not exceeding RM2,000 or imprisonment for a term not exceeding one (1) year or to both, and in the case of a continuing offence, to a fine not exceeding RM200 for each day during which the offence is continued after conviction.
Pursuant to the Advertisement By-Laws, any person shall not exhibit or cause or permit to be exhibited any advertisement without a licence granted by DBKL.
The Advertisement By-Laws further states that any person who contravenes any of the Advertisement By-laws shall be guilty of an offence and shall on conviction be liable to a fine not exceeding RM2,000 or to a term of imprisonment not exceeding one(1) year or to both.
There are similar requirements under the respective by-laws of other local authorities, amongst others, Penang which is a medical device manufacturing hub among word-class manufacturers[4].
(f) Other compliance/regulatory requirements
Other compliance/regulatory requirements may include, amongst others, health and safety, intellectual property, contracts, product liability, anti-corruption and anti-bribery, privacy/personal data protection, cybersecurity, environmental, social and governance (ESG) and competition law related requirements in relation to the operation of the medical device/MedTech companies particularly relating to MNCs that have their presence globally.
(2) Commercial contracts
Commercial contracts in relation to the operation of the medical device/MedTech companies may involve contracts such as, amongst others, distribution agreements, tender documents, and supply/service agreements which require reviews from both commercial and legal/compliance perspective.
Please note that the above is merely a summary of the relevant laws and regulations and commercial contracts based on the author’s experience – the above does not purport to be an exhaustive description of all relevant laws and regulations and commercial contracts of which the medical device/MedTech companies/industry is subject to.
This article dated 3 February 2025 is contributed by Maple Chieng from Maple Chieng & Co. for general information only and is not a substitute for legal advice.
Maple Chieng & Co is experienced in providing consultation to the medical device/MedTech multinational corporation – please refer to the “client success stories” section at our website at https://www.maplechiengco.com/ for further information.
If you have any specific queries or require advice/assistance, please contact us at maple@maplechiengco.com
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