Medical Device Registration in Malaysia : An Overview

Introduction to Malaysia Medical Device Regulations

Malaysia is amongst the strongest and most dynamic market for foreign medical device manufacturers due to the country’s strong emphasis on medical tourism. With the changes brought about by the regulatory reform process, registration of medical devices has become mandatory. Documentation of compliance with Malaysian medical device regulations must be provided by the manufacturers in order to get approval.

Registration and regulation of medical devices are done by the Malaysian Medical Devices Authority (MDA). All foreign manufacturers have to get CAB certification in order to receive MDA approval for registration of their products.

Steps for Medical Device Registration in Malaysia 

Step 1: Appointment of an Authorised Representative in Malaysia

For foreign manufacturers who do not have any representation locally, an Authorised Representative (AR), distributor, or subsidiary has to be appointed to possess the licence and handle registration. The AR serves as the local representative both before and after the issuance of the registration. The AR will prepare technical data following the Common Submission Dossier Template (CSDT) and submit it using the MDA portal.

Step 2: Obtaining Conformity Assessment Body (CAB) Certification

The independent CAB examines the dossier and provides a certificate which should then be submitted to the MDA. The product will not be approved without CAB certification. In order to facilitate the review process, the manufacturers are recommended to submit documents demonstrating their compliance with regulations in other countries like the USA, EU, Australia, and Canada.

Step 3: Required Documents for Medical Device Registration in Malaysia

There are a number of documents that are necessary for the registration of a medical device. They include general information about the medical device, information regarding the manufacture of the device, and the classification of the device. It is necessary to have the Common Submission Dossier Template (CSDT), information on post market vigilance history, conformity declaration, and attestation for medical device registration. Moreover, the IFU and the product labeling must also be provided, along with a quality certificate from ISO 13485.

Step 4: Registration Process and Approval Timeline

After the classification of the product and designation of an AR, the AR will fill out the required documentation through the online portal of the MDA. There is no need for any kind of local testing or clinical trials; nevertheless, the approval by the country of origin is a must. The time taken for the process is roughly nine months, and the approval is good for five years.

Guidelines for Refurbished Equipment and Malaysia Medical Device Regulations

In addition to new devices, the registration of any refurbished device in Malaysia is also mandatory before it can be brought into the country. Registration of a refurbished device is done using the centralized online application, with the registration being done by either the manufacturer or its authorized representative.

The registration of the establishment for manufacturers is done using the MeDC@St system, while the registration of establishment for the authorized representative is done using the MeDCP system. In case of the manufacturers, the activities related to refurbishment of the devices should be included in the ISO 13485 under clause 7.5, while for the authorized representative, compliance with Good Distribution Practice for Medical Devices (GDPMD) is mandatory. It should also be noted that both should ensure compliance of the refurbishment activities with Good Refurbishment Practice for Medical Devices (GRPMD).

Labeling is very crucial when it comes to labeling of refurbished devices. In addition to compliance with the requirements under MDA/GD/0026, the term "refurbished" should also appear on the label of the device. Moreover, there should be different catalog numbers with suffix [R].

Application Procedure for Refurbished Medical Devices under Malaysia Medical Device Regulations

The application to register refurbished medical devices is available on the online system called MeDC@St. It is a web-based system that needs the establishment to set up an account before filling out the application form.

The device should be labeled according to the guidelines stated under MDA/GD/0026: Requirement for Labeling of Medical Devices, which states the registration number and other required information. Any changes should be formally notified to the authority through a change notification.

Evaluation Timeline

Financial Framework of the Malaysian Medical Device Authority Table of Fee

Application Fee

Registration Fee

Staying Updated with MDA Regulations: MDA-RIS Subscription

December 2022 saw the introduction of Medical Device Authority Regulatory Information Subscription (MDA-RIS) by the Malaysian Medical Device Authority. This scheme guarantees that stakeholders and the public get instant information on any regulatory changes concerning medical devices. One will need to fill an online form with correct information. The application form being filled will be followed by issuance of an invoice to the email of the registrant. Upon payment of RM100 annual subscription fee and its clearance, one gets confirmed by email. The subscribers will be informed promptly via email of any new regulations. The continuity of the service is guaranteed through an email reminder sent thirty days to expiry of subscription period.

This subscription is one of the most effective ways that manufacturers and distributors can ensure they comply with the regulations set by the Malaysian Medical Device Authority. In addition to helping companies in the medical device registration process, Morulaa HealthTech can help companies understand regulatory changes in Malaysia and also Southeast Asia at large.

Choosing a Medical Device Registration Consultant Malaysia Customs Documentation and Preferential Rates for ASEAN Goods

Registration for Medical Devices in Malaysia can be done by local manufacturers as well as their Authorized Representative. Importers will have to acquire the Establishment License before undertaking the activity of importing the devices. Declaration needs to be filed in case of all imported medical devices and includes details about the registration number of the device, description, packaging details, cost, weight, quantity, and country of origin.

All customs duties and taxes must first be paid in advance through electronic transfer before authorization can be given. The applicant needs to provide a customs entry form, bill of lading/air waybill, pro-forma invoice, packing list, Certificate of Registration provided by the MDA, and any other license/certificates that may be necessary for the importation of the product. Importations coming from the ASEAN countries like China, Japan, Korea, Pakistan, Australia, New Zealand, India, and Chile could get a preferential rate on duties.

How Morulaa Can  Supports Your Medical Device Registration in Malaysia

Morulaa Health Tech specializes in being a medical device registration consultant Malaysia and is focused on providing regulatory consultation and import consulting services in Southeast Asia. Our professionals provide assistance in the appointment and coordination of the Authorized Representative, the submission of the CSDT document and liaison with the CAB and the Malaysian Medical Device Authority for the certification of the product. We take care of the compliance of the product with the customs laws along with providing regulatory updates to our clients. Morulaa will be your go to medical device registration consultant Malaysia and will provide you with end-to-end regulatory assistance.