Medical device registration in Malaysia
Medical device registration in Malaysia is regulated by the Medical Device Authority (MDA), a federal statutory agency under the Ministry of Health (MoH). The MDA implements and enforces the Medical Device Act 2012 (Act 737). All medical devices that are imported, exported or placed on the market in Malaysia whether manufactured domestically or not, must be registered with the Medical Device Authority (MDA) before they can be supplied in Malaysia. All applications for medical device registration must be done via the online system called Medical Device Centralized Online Application System (MeDC@St 2.0) otherwise known as Medcast.
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.
As only local (Malaysian) companies can apply for an Establishment License, foreign manufacturers, therefore, have three (3) possibilities to register their medical device in Malaysia:
Set up a legal subsidiary entity
to register the medical device.
Appoint a local importer or distributor
who has a valid establishment license, Good Distribution Practice for Medical Devices (GDPMD) certification and a Registrant Account in Medcast system to register the medical devices.
Appoint an independent Authorized Representative
such as Andaman Medical to register the medical devices. Andaman Medical has a valid Medcast Registrant Account and acts directly on behalf of foreign manufacturers. We register and maintain your device license which also means you have the freedom to appoint as many importers or distributors for your device as you require while the product license will not be affected by any changes in the distributor network.
About Medcast (Medical Device Centralized Online Application System)
MeDC@St 2.0 is Malaysia’s web-based centralized Online Application System for Establishment Licensing, Medical Device Registration or Export Permit. The parties who deal with medical devices and operate their businesses in Malaysia such as manufacturers of medical devices, importers or exporters of medical devices, distributors of medical devices or Authorized Representatives of medical devices must use this system for the submission of any application, particularly medical device registration application to the MDA.
What is considered a medical device in Malaysia?
The term ‘medical device’ covers any product used in healthcare for the diagnosis, prevention, monitoring or treatment of illness or disability but excludes drugs. This definition of medical device includes in-vitro diagnostics (IVDs). Any medical device must comply with Section 2 of Act 737 (refer to guidance document MDA/GD/0006) and shall register under the Act before it can be imported, exported or placed in the market.
Please note: in this webpage we will use the term medical devices to include medical devices as well as in-vitro diagnostics.
Medical device classification in Malaysia
The ruled-based classification of medical devices is based on the risk associated with the vulnerability of the human body, the technical design of the medical device and its manufacture. The rules are based on:
Medical devices for registration in Malaysia are be classified into 4 classes: Class A, B, C, and D. The corresponding risk level and device examples are given in the table below:
|Class||Risk Level||Device examples|
|A||Low||Simple surgical instruments, tongue depressor, liquid-in-glass thermometer, examination light, simple wound dressing, oxygen mask, stethoscopes, walking aids|
|B||Low-Moderate||Hypodermic needles, suction equipment, anesthetic breathing circuits, aspirator, external bone growth simulators, hearing aids, hydrogel dressings, patient-controlled pain relief, phototherapy unit, x-ray films|
|C||High-Moderate||Lung ventilator, orthopedic implants, baby incubator, blood oxygenator, blood bag, contact lens disinfecting/cleaning products, deep wound dressing, defibrillator, radiological therapy equipment, ventilator|
|D||High||Pacemakers and their leads, implantable defibrillators, implantable infusion pumps, heart valves, inter-uterine contraceptive devices, neurological catheters, vascular prostheses, stents|
Medical device grouping in Malaysia
Under the Medical Device Act 2012, the manufacturer or the Local Authorized Representative of the foreign manufacturer is required to register a medical device before importing, exporting or placing it in the Malaysia market.
There is a wide range of medical devices from a simple medical device to a highly complex and sophisticated medical device. The various components can be sold as a separate component, individual customized pack or group and can be categorized as SINGLE, FAMILY, SYSTEM, SET, IVD TEST KIT, and IVD CLUSTER. Each of the categories mentioned can be submitted in the medical device registration application.
In Malaysia, general medical devices, may be grouped into one of the following categories as:
IVD Test Kit
Groupings are allowed if all of the following conditions are met:
one generic proprietary name
one manufacturer; and
one manufacturer; and
The registration process
In order to submit a medical device registration application in Malaysia, medical devices must first undergo a conformity assessment by one of the 19 registered Conformity Assessment Bodies (CAB). This is a systematic examination of evidence generated and procedures undertaken by the manufacturer under the requirements established by the MDA to determine that a medical device is safe and performs as intended by the manufacturer and, therefore, confirms to the Essential Principles of Safety and Performance for Medical Devices.
According to section 7 of Act 737, conformity assessment is mandatory for Class A, B, C and D devices. However, following the implementation of the Medical Device (Exemption) Order 2016, Class A medical devices are now exempt from conformity assessment procedures by a CAB. Therefore, class A medical devices can directly submit their registration application via Medcast.
For class B, C and D medical devices which have undergone conformity assessment and have obtained approval in countries recognized by the MDA, such as the USA, EU, Canada, Australia and Japan, there is a simplified and accelerated process for CA following implementation of MDA Circular Letter No 2/2014.
For class B, C and D medical devices yet to obtain approval in one of the recognized countries, they need to have at least approval from the country of origin. In this case, a full evaluation shall be conducted by the CAB, albeit with a longer timeline due to a more detailed evaluation.
Once the CAB approval certificate has been received, class B, C and D medical devices can submit their application for registration via Medcast.
What documents are required to register medical devices in Malaysia?
Various documentation is required to register a medical device in Malaysia. The language accepted for submission is English. In general, you will be required to submit a Common Submission Dossier Template (CSDT), which includes an executive summary, device description, any pre-clinical studies, clinical evaluation, device labelling, instructions for use, a risk analysis, proof of quality management system, manufacturing information, essential principle checklist along with a declaration of conformity and of course any existing regulatory approvals or market authorizations already obtained.
Certain products require additional documentation such as those which contain or transmit radiation or derived from animal tissues or have Bluetooth and wireless network features.
Medical device registration timeline and fees in Malaysia
When a medical device registration application is submitted, the MDA will impose an Application Fee for all classes of medical device. Please note that the MDA will only start their evaluation process once payment of the application fee has been received. When the registration application has been approved, the MDA will impose another fee called Registration Fee for issuing the formal registration certificate of the medical device. Please note that Class A products are exempt from the registration fee.
The MDA’s medical device fees and timelines are summarized below:
Scroll left or right to see the full table
|Class||Application Fee Payable (RM)||Registration Fee Payable (RM)||Turn-Around Time (Working Days)|
For medical devices that contain a medicinal product, the registration fee imposed by MDA will be MYR 5,000 despite the medical device classification rules.
How Andaman Medical can help:
Andaman Medical 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.