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@St2.0+) which is another enhancement to the online application system 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 MeDC@St2.0+ 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 is the acronym of Medical Device Centralised Online Application System, an online system to manage various applications made to MDA 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.
Since its launch in July 2013, MeDC@St has been upgraded to MeDC@St 2.0 in January 2019. Commencing 1 February 2022, MDA is proud to introduce another enhancement to the online application system, ie the MeDC@St2.0+, which will incorporate additional features for the benefit of the users. MeDC@St2.0+ is evidence of the commitments for continuous quality improvement of our services Additional features MeDC@St2.0+ incorporates the new features such as Change Notification Module, Device Study sub-module (under Clinical Research module), Clinical Research Use sub-module (under Clinical Research module), Demonstration for Marketing Notification and Payment module.
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
For General Medical Devices, the classification of the device is based on the risk associated to it at the point of usage (The risk to patients, users and other persons). The risk presented by a particular device depends on:
- Its intended purpose
- The effectiveness of the risk management techniques applied during design, manufacture, and use
- Its intended user(s)
- Its mode of operation
- Technologies
A number of factors may influence medical device classification. These include:
(i) The duration of contact of the device with the body.(ii) The degree of, and site of, invasiveness into the body.
(iii) Whether the device deliver medicines or energy to the patient.
(iv) Whether the device is intended to have a biological effect on the body.
(v) Intended action on the human body.(vi) Local versus systemic effects.
(vii) Whether the device comes into contact with injured skin.
(viii) Whether for diagnosis or treatment,
(ix) The ability to be re-used or not, and
(x) Combination of devices.
For General Medical devices registration in Malaysia can 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 |
For IVD Medical Devices, it uses a set of classification rules based on:
- Intended use
- The technical / scientific / medical expertise of the intended user (lay person or healthcare professional)
- The importance of the information to the diagnosis (sole determinant or one of several), taking into consideration the natural history of the disease or disorder including presenting signs and symptoms which may guide a physician;
- The impact of the result (true or false) to the individual and / or to public health.
For IVD Medical Devices registration in Malaysia can 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 | Clinical Chemistry Analyser, Prepared Selective Culture Media |
| B | Low-Moderate | Vitamin B12, Pregnancy Self-Testing, Anti-Nuclear Antibody, Urine Test Strips |
| C | High-Moderate | Blood Glucose Self-Testing, HLA Typing. PSA Screening, Rubella |
| D | High | HIV Blood Donor Screening, HIV Blood Diagnostic |
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.
For general 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. 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:
Single
Family
System
Set
For IVD medical devices, may be grouped into one of the following categories as:
Single
Family
System
IVD Test Kit
IVD Cluster
Groupings are allowed if all of the following conditions are met:
1.
one generic proprietary name; and
2.
one manufacturer; and
3.
one manufacturer
The registration process for General and IVD Medical Devices
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, UK and Japan, there is a simplified and accelerated process for CA following implementation of MDA Circular Letter No 2/2014, Appendix 1 Rev 5: 25th Apr 2022.
Medical devices for class B, C and D which have not obtained any approval by regulatory authorities or notified bodies listed in Table 1 of Circular Letter No 2/2014, Appendix 1 Rev 5: 25th Apr 2022 is required to undergo full conformity assessment by any registered CAB in accordance with the requirements stipulated in Section 7(1)(a) of Act 737.
Once the CAB approval certificate has been received, class B, C and D medical devices can submit their application for registration via MeDC@St2.0+.
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.
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.
Additionally, all payment in MeDC@St 2.0+ system must be made within 60 days from the date of invoice generated enforced on 1st February 2022. Failing to do so, the current application will automatically be dropped from the system and a new application has to be made following the announcement by the MDA on ENFORCEMENT ON PAYMENT ADVICE TERM FOR ALL PAYMENT FEES IN MEDC@ST 2.0+.
The MDA’s medical device fees and timelines are summarized below:
Scroll left or right to see the full table
For General and IVD Medical Devices
| Class | Application Fee Payable (RM) | Registration Fee Payable (RM) | Turn-Around Time (Working Days) |
|---|---|---|---|
| A | 100 | Not Applicable | 30 |
| B | 250 | 1000 | 100 |
| C | 500 | 2000 | 180 |
| D | 750 | 3000 | 220 |
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.
Our registration services include:
- Standard product registration
- Special access product registration
- Renewal of product registration
- Change notification
- Product license transfer
Our authorized representative services include:
- Liaison with the local authorized government agency on all regulatory issues relating to your medical device including amendment and change notifications
- Regulatory monitoring to alert you to any changes or new regulation applicable to your product
- License holding
- Adverse event reporting and management
- Product alert and recall tracking
- Complaint handling
We also offer additional support services such as:
- Regulatory intelligence reports giving you insight into the best routes for market access and the latest on the regulatory landscape in your target market
- Online regulatory training