Medical device importation to Malaysia

Only registered medical devices may be imported into Malaysia, which means that the product is listed on the Malaysian Medical Device Authority Register (MDAR) unless exempted from registration (see below). Any company wishing to import medical devices and in-vitro diagnostics (IVDs) into Malaysia must have a valid Establishment Licence as an Importer from the Medical Device Authority (MDA).

What are the requirements for importing medical devices into Malaysia?

Are there any exemptions or exclusions?

Special Access Routes for importing medical devices into Malaysia

Importers duties and obligations

It is mandatory for importers of medical devices and IVDs to Malaysia to:

How Andaman Medical can help with importing medical devices to Malaysia:

Acting as your independent local authorized representative or marketing authorization holder in Malaysia, we will work with your licensed importers to:

Get a quote on our how we can help you access the Malaysian medical device market

Medical device distribution in Malaysia

Only registered medical devices may be distributed in Malaysia, which means that the product is listed on the Malaysian Medical Device Authority Register (MDAR), unless exempted from registration.

Who can distribute medical devices in Malaysia?

What are the requirements for distributing medical devices in Malaysia?

Advertising rules

Advertising, communication and promotion of medical device is a common part of a distribution contract, either falling to the manufacturer or the local distributor to undertake. Please note that Malaysia is currently in a transitional period until 31st December 2021 for the implementation of Medical Device (Advertising) Regulation 2019 while the MDA specifies details for its implementation.

According to the Medical Device (Advertising) Regulation 2019, no person shall advertise any registered medical device without the approval from the Authority. Any person who commits an offence, shall, upon conviction, be liable to a fine not exceeding two hundred thousand ringgit or to imprisonment for a term not exceeding two years, or to both.

The Medical Device (Advertising) Regulation 2019 states that applications for approval for an advertisement shall be submitted in writing to the MDA along with a copy of the proposed advertisement, the processing fee of one thousand ringgit (approx. 235 US Dollars) and a letter of appointment from the establishment whose medical device is being advertised if applicable. Each advertisement must include the registration number assigned by the MDA to the said medical device.

Distributor’s duties and obligations

It is mandatory for distributors of medical devices and IVDs to Malaysia to:

How Andaman Medical can help with distributing medical devices in Malaysia:

Acting as your independent local authorized representative or marketing authorization holder in Malaysia, we will register and maintain your device license which also means you can appoint as many distributors for your device as you require while the product license is not affected by any changes in your distributor network. We will work with your chosen distributor(s) to:

We also offer additional support services such as:

Obtain a quote on accessing the Malaysian medical device market

Malaysia’s Medical Device Market

The medical device market in Malaysia

Regulatory authority and laws governing medical devices in Malaysia

Malaysia’s healthcare system

Medical tourism

Industry associations

General economic and demographic statistics

How Andaman Medical can help you access the Malaysian medical device market

Regulatory Services for Malaysia

Market Access Services for Malaysia

Obtain a quote on accessing the Malaysia market

Post Market Surveillance of Medical Devices in Malaysia

The Medical Devices (Duties and Obligations of Establishment) Regulations 2019 detail the requirements for post market surveillance and vigilance for all medical devices in Malaysia as legislated for in Chapter 3 of the Medical Devices Act 2012 (Act 737). These regulations are imposed to ensure manufacturers, importers, distributors and local authorized representatives carry out their responsibilities to monitor and continuously ensure the safety and performance of medical devices that are placed in the market. As a member country of ASEAN, these regulations uphold the ASEAN Medical Device Directive (AMDD) which came into effect on 1st January 2015. Please read on to understand how post market surveillance is implemented in Malaysia.

In Malaysia, post market surveillance is separated into 4 different categories:

1.

Mandatory Problem Reporting

2.

Complaint Handling

3.

Field Corrective Action

4.

Medical Device Recall

Mandatory Problem Reporting

Mandatory problem reporting, referred as to Adverse Event (AE) reporting in the ASEAN Medical Device Directive (AMDD), is a post marketing risk assessment measure to ensure the continued safe use of medical devices as part of a post market surveillance system. This includes:

The MDA will evaluate the investigation report and if the report and action taken are satisfactory, the MDA will inform the establishment in writing to close the matter.

*The requirement to submit a mandatory report does not apply to any incident that occurs outside Malaysia if that incident has been reported by the establishment to the regulatory agency of the country in which the incident occurred and a field corrective action has been undertaken by the manufacturer or establishment in the country where the incident occurred and on all the affected devices placed in the Malaysian market as specified by Regulation 5(7) of Medical Device (Duties and Obligations of Establishments) Regulations 2019.

Complaint Handling

Establishments must provide a standard form for submitting complaints relating to their medical device. The establishment shall provide instructions on where to submit the complaint form. Complaints may come from users of medical device such as patients, home users, healthcare practitioners, maintenance providers, or the general public.

Field Corrective Action (FCA)

Field Corrective Actions, also referred to as Field Safety Corrective Action (FSCA) in the ASEAN Medical Device Directive (AMDD), may arise from post market surveillance information such as product complaints, incidents (such as those mentioned above in mandatory problem reporting), market surveys, research and development activities and others.

FCAs might also be required by the MDA for medical devices that are no longer in the market or have been discontinued but could possibly still be in use (e.g., implants).

Field Corrective Actions are carried out to reduce a risk of death or serious deterioration in the state of health associated with the use of a medical device. This may include:

a) medical device recall
b) device modification due to potential nonconformity, such as retrofitting, changes to the labelling or instructions for use, software upgrades, modification to the clinical management of patients.
c) medical device exchange
d) medical device destruction; and
e) specific advice given by establishment regarding the use of the medical device.

Medical Device Recall

Recall is part of a post-marketing risk assessment measure to ensure the continued safe use of medical devices and is an important part of the post-market surveillance system.

Voluntary Recall

Recall is any action taken by the establishment of the medical device to remove the medical device from the market or to retrieve the medical device from any person to whom it has been supplied and to notify its affected person of its defectiveness or potential defectiveness, after becoming aware that the device:

a) may be hazardous to health
b) may fail to conform to any claim made by the manufacturer/ Authorized Representative relating to its effectiveness, benefits, performance characteristics or safety or
c) may not meet the requirements of the law.

Mandatory Recall

The MDA has the right to order a medical device recall if a medical device possesses a high public health risk from the market as described in section 42 (4) of Medical Device Act 2012 (Act 737). The establishment is responsible for all recall procedures as per Clause 3. The Authority will monitor the whole recall process and may also take a role in communicating with stakeholders involved if necessary.

The Authority will assess the health hazard presented by a medical device that is being considered for a mandatory recall action. As examples, the following factors may be taken into account:

a) whether any serious illness or injury has already occurred from use of the device, and the likelihood of occurrence of the incident when the device is continued to be used
b) whether any existing conditions could contribute to a clinical situation that could expose the public to a health hazard
c) whether it gives potential hazard to individual groups within the exposed population (such as children, the elderly, patients having surgery or to those who are with special conditions, as an example: immune compromised individual), and the degree of seriousness of the health hazard to which the population will be exposed
d) whether there are serious illnesses and injuries reported that have already occurred from the use of the device, and the establishment is aware about the risk but not acting on its own initiative
e) whether alternative treatment options are available, including the risk associated with providing no treatment if an alternative is not available.

How Andaman Medical can help you with post market surveillance in Malaysia

With 6 local offices throughout Southeast Asia, Andaman Medical provides support for your post-market surveillance activities including mandatory problem reporting and FCA as part of our local authorized representative services. Our local, in-house staff liaise with the MDA to help you maintain compliance once your medical device is placed on the market. Our services include:

Get a quote on our PMS services in Malaysia

Local authorized representative in Malaysia

The Medical Device Authority (MDA) in Malaysia requires foreign manufacturers who have not set up their own legal subsidiary to appoint a Local Authorized Representative (LAR). The LAR is also called an in-country representative or marketing authorization holder.

Andaman Medical has been a Local Authorized Representative in Malaysia since 2014.

Medical device manufacturers and distributors appoint Andaman Medical to represent them in Malaysia regarding all matters raised by the MDA; the legal authority for medical devices in Malaysia. As your authorized representative we will have the authority to act on your behalf concerning your obligations under the Malaysian medical device regulatory system.

What are the requirements for a local authorized representative in Malaysia?

Can you appoint multiple marketing authorization holders or representatives in Malaysia?

What Andaman Medical will do as your local authorized representative in Malaysia:

As your local authorized representative in Malaysia we will:

  • registering your product
  • submitting change notifications
  • transferring product licences
  • ensuring post-market surveillance once your product is authorized and placed in the market, including Mandatory Problem Reporting, Complaint Handling, Field Corrective Actions and Product Recall

Get a quote for in-country representation services in Malaysia

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:

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:

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:

Medical device grouping in Indonesia Single

Single

Medical device grouping in Indonesia Family

Family

Medical device grouping in Indonesia System

System

Medical device grouping in Indonesia Group

Set

For IVD medical devices, may be grouped into one of the following categories as:

Medical device grouping in Indonesia Single

Single

Medical device grouping in Indonesia Family

Family

Medical device grouping in Indonesia System

System

Medical device grouping in Indonesia IVD Test

IVD Test Kit

Medical device grouping in Indonesia IVD Cluster

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 Revision 4 effective since 13 October 2021.

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 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:

Our authorized representative services include:

We also offer additional support services such as:

Obtain a quote to register medical devices in Malaysia

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