Medical Device Regulatory Affairs Services in Malaysia

Your Partner for End-to-End Regulatory Affairs Services in Malaysia, From Strategy to Registration and Post Approval Maintenance. We help medical device firms in Malaysia with product approvals, MoH coordination, and clear regulatory guidance every step of the way.

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Regulatory Affairs Services for Medical Devices in Malaysia

Artixio offers extensive Malaysia Medical Device regulatory services to global manufacturers, facilitating smooth navigation of Malaysia’s MDA regulations.

Medical Device Authority (MDA) regulates the import, manufacture, export and supply of medical devices in Malaysia to safeguard public health and safety.

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Key Regulations for Medical Devices in Malaysia

Medical Device Act 2012 (Act 737)

Medical Device Authority Act 2012 (Act 738)

Classification of Medical devices In Malaysia

In Malaysia, devices are classified to Class A, B, C and D depending on their risk level. Class A devices have low risk to patients, Class B devices are low to moderate risk, Class C devices are moderate to high risk while Class D devices are high risk, complex devices.

Process for Registration of Medical Devices in Malaysia

Required Documents for Medical Device Registration in Malaysia

The documents required for medical device Malaysia are in accordance with CSDT, below are the elements

Executive Summary
Device Description
Design Verification & Validation
Clinical Evidence
Device Labelling
Risk Analysis
Manufacturer Information

Artixio’s Medical Device Registration Services in Malaysia

Our Medical Device Regulatory and Market Access experts based in Malaysia, coupled with the Global Regulatory Projects team, have helped over a hundred pharmaceutical, medical devices, diagnostics, cosmetics, nutraceuticals, supplements, and veterinary products successfully register and maintain compliance in Malaysia. Combined with Artixio’s intelligence-based services platform, Dvarka, innovators and manufacturers from around the world have benefited by seamlessly managing the regulatory strategy across the product development and commercialization value chain.

From planning your regulatory pathway to handling approvals and post-market requirements, Artixio helps you manage every step of medical device compliance in Malaysia—efficiently and with confidence.

Why Choose Artixio for Medical Device Approval in Malaysia

Market Entry Regulatory Advisory Services – Malaysia

FAQs

If we have created MeDC@St account. Do we need to apply for establishment license, medical device registration or both?

All establishments, that is manufacturers, authorized representative (AR), importer and distributor must apply for establishment license. Yet only manufacturers and authorized representative (AR) need to apply for medical device registration.

How do we notify MDA in terms of changes (E.g. change manufacturing site from one country to another country etc.)?

At the moment, writing to MDA will help with additional necessary changes. If changes of certificate, the latest certificate must be submitted to MDA. Example changes of manufacturing sites for GDPMD/ISO 13485, certificate must be submitted to MDA together with the application for amendment.

Does the authorized representative (AR) require local staff working in the Malaysia office? If our office staff is handling everything from other countries, is this acceptable?

If the medical device is planned to place in Malaysia market, then it is subjected to Act in Malaysia. AR must be licensed and should live in Malaysia

How to apply for re-registration?

Re-registration can be applied through the MeDC@St application system. The re-registration button will be seen 1 year prior to expiry date. If the re-registration button does not appear within 1 year prior to expiry in the application system you can notify the helpdesk.

Does AR info and registration number need to be put on primary packaging or secondary or both

AR information and registration number shall be on the packaging where the information can be accessed at the point of receiving by the customers/users. The Registration number and AR information should be on the packaging so the customers or users can access it when they receive the product.

Medical Device Regulatory Affairs Services in Malaysia

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Regulatory Affairs Services for Medical Devices in Malaysia

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Regulatory Intelligence & Strategy

MDR Gap Assessment