MEDICAL DEVICE DISTRIBUTION/IMPORTATION: INTRODUCTION TO THE LICENSING REGIME IN MALAYSIA
The medical device industry is a fast-growing industry. Prime Minister Anwar Ibrahim recently announced an allocation of RM41.22 billion for the Ministry of Health (MOH) in Budget 2024, a huge increase of about 13.5 per cent from RM36.3 billion allocated in Budget 2023. Having said that, stepping foot into this industry requires some regulatory requirements to be met. Some requirements can be lengthy and confusing, we summarize below a few pertinent points to get you started legally.
Licensing Regime for Medical Devices in Malaysia
The Medical Device Act 2012 (Act 737) is the primary legislation governing medical devices in Malaysia. It regulates the importation, exportation, manufacture, distribution, and sale of medical devices in the country. MDA is the government agency entrusted to serve the Malaysian medical device industry. It is a federal statutory agency under the Ministry of Health Malaysia to implement and enforce the Medical Device Act 2012 (Act 737). 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.[1]
Establishment License
The Establishment License is the first and most important to be obtained by all medical device establishments, including manufacturers, authorised representatives (AR), importers, and distributors. [2] Please take note OEM or tendering agent is not defined as establishment.[3]
An AR is a person or company that is authorized by the manufacturer to represent the manufacturer in Malaysia and to register medical devices on the manufacturer’s behalf.
If you are just any natural or legal person in the supply chain who, on someone’s behalf, places a medical device on the market and furthers the availability of the medical device to the end user, then you are a distributor.[4]
An importer is a distributor (a person or company) appointed by an AR (for medical devices manufactured in a foreign country) or a manufacturer (for locally manufactured medical device) to further medical devices registered by the AR or the manufacturer into the Malaysian market. A distributor shall only distribute registered medical devices authorized and on behalf of the AR or the manufacturer.
In short, all manufacturers, authorised representatives (AR), importers and distributors shall obtain an establishment license to conduct their activity.
Good Distribution Practice Medical Devices / ISO13485
The requirement of quality management system (QMS) is mandatory for the application of establishment license under the Third Schedule of Medical Device Regulation 2012 for the application of establishment license.[5]
|
Type of establishment |
QMS |
|
Manufacturer |
ISO13485 |
|
Authorised Representative |
Good Distribution Practice for Medical Devices (GDPMD) |
|
Importer |
Good Distribution Practice for Medical Devices (GDPMD) |
|
Distributor |
Good Distribution Practice for Medical Devices (GDPMD) |
Medical Device Registration
Medical Device Registration must be made before a medical device can be imported and exported or placed in the market in Malaysia. However, for such registration, usually the product owners i.e., manufacturer or AR of the manufacturer need to apply for this registration.
In this case, it is important to note what a medical device covers according to section 2 of the Medical Device Act 2012. The term “Medical Device” covers any product used in healthcare for the diagnosis, prevention, monitoring or treatment of illness or handicap but excludes drugs.
Importation of Medical Devices into Malaysia
To import medical devices into Malaysia, the importer must have a valid establishment license from the MDA. The importer must also obtain a Letter of Authorization (LOA) from the AR of the medical device. The LOA authorizes the importer to import and distribute the medical device in Malaysia.
All medical devices that are imported into Malaysia must be registered with the MDA. The AR is responsible for registering the medical device on behalf of the manufacturer. Once the medical device is registered with the MDA, the importer can import the device into Malaysia.
Exemptions
There are a few exemptions to the licensing and registration requirements for medical devices. However, the importer must still notify the MDA of the importation of such medical devices. The following medical devices are exempt from registration:
- Medical devices that are imported for personal use;
- Medical devices that are imported for the purpose of demonstration for marketing or education;
- Medical devices that are imported for clinical trials;
- Medical devices that are imported for re-export; and
- Medical devices that are manufactured and sold in Malaysia under the supervision of a registered pharmacist.
Conclusion
The licensing regime and importation process for medical devices in Malaysia is designed to ensure the safety and quality of medical devices in the Malaysian market. Importers of medical devices must ensure that they comply with all applicable requirements in order to avoid legal penalties.
Please reach out to Ng Law Firm should you need any help and advice at +601154304970 or +6046024970. You may also email your enquiry to penang@nglaw.com.my.
**No Legal Advice**: The information provided in this article is intended for informational purposes only. It should not be considered as legal advice. You should not act or refrain from acting based on this information without first seeking appropriate legal or other professional advice.
[1] https://www.mda.gov.my/introduction/background.html
[2] Section 15(1) of Medical Device Act 2012 (Act 737(
[3] How to Apply for Establishment Licence – Medical Device Authority (MDA)
[4] MDA/RR/No. 1: November 2015 First Revision Good Distribution Practice for Medical Device (GDPMD)
[5] P.U. (A) 500: December 2012 Medical Device Regulations 2012
