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Medical Device Product Registration (MDA)
Who can register a medical device in Malaysia?
Only companies registered locally in Malaysia with the Companies Commission (SSM) (government authority responsible for company registrations) may apply to obtain an establishment license, register a medical device and apply for an export permit. Once registered with the SSM, a company needs to create just one account on Medcast from where they apply initially for an Establishment License according to their activity: Manufacturer’s License, Importer’s License, Distributor’s License or Authorized Representative’s License. Only companies which have an Establishment License can register a medical device in Malaysia.
Kazami Group is a regulatory affairs and market access consultancy that specializes in the registration, authorized representation, importation and master distribution of medical device and in-vitro diagnostics in Southeast Asia.
Our in-house team of local, experienced regulatory affairs specialists provide unrivalled assistance to medical device manufacturers and distributors alike who benefit from accessing real, on-the-ground expertise.
In Malaysia, applications for licensing & device registration must be submitted online via MeDC@St (Medical Device Centralised Online Application System).
Government Authority
Medical device product registration in Malaysia is overseen by the Medical Device Authority (MDA) of the Ministry of Health Malaysia (MoHM), as stipulated under the Medical Device Act 2012, which was made effective on July 1, 2013. According to the act, medical devices require registration with the MDA before being imported and placed on the market.
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Medical Device Status
In Malaysia, a medical device is 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 diagnosis, prevention, monitoring, treatment or alleviation of disease or injury.
Medical device including IVD is classified into 4 classes, namely:
- Class A: Minimal risk (hospital beds, surgical instruments, etc.)
- Class B: Low to moderate risk (syringe with needle, blood collection tube, etc)
- Class C: Moderate to high risk (dental x-ray machine, foam dressing, etc.)
- Class D: Highest risk (implantable devices/devices that significantly affect the physiology of the human body)
In general, Class A, Class B, Class C, and Class D medical devices have to be registered with MDA before it can be supplied in the Malaysian market.
Product registration dossier must be prepared in accordance with ASEAN Common Submission Dossier Template (CSDT). In the application, Kazami will work with the manufacturer on the device classification, grouping and CSDT preparation.
Product Grouping is also allowed in Malaysia either as Single, Family, System, Set, IVD Test Kit or IVD Cluster
In Malaysia, applications must be submitted online via MeDC@St (Medical Device Centralised Online Application System).