Medical Device Registration in Malaysia

Utilize our intimate industry knowledge and expertise to obtain Malaysia MDA registration approval for your medical device.

If you are ready to begin your medical device registration process in Malaysia, please contact us today.

Medical Device Registration in MalaysiaMalaysia’s medical device market is primarily composed of imports, in particular high-end products. Up until recently, registration of medical devices and medical device establishments with the Malaysian government was voluntary. Now, all medical devices are expected to be registered.

Due to the regulatory changes, the registration process could be complicated or extended to as long as a few years. The regulatory consultants at Pacific Bridge Medical can work with you to register your medical devices as efficiently as possible and obtain approval under Malaysia’s new regulatory system. We will ensure that your products are compliant with the Malaysian device regulations.

Click on the questions below for more information about Malaysia’s medical device registration process, regulations, and pathway to approval.

Which regulatory bodies in the Malaysian government are responsible for medical device registration in Malaysia?

The Malaysian Medical Device Authority (MDA) is in charge of enforcing medical device regulations and medical device registration.

In Malaysia, are medical devices required to be registered before they can be sold?

Yes, medical devices do require registration before they can be sold in Malaysia. Starting on July 1, 2016, Malaysia’s Medical Device Act has made it mandatory for all foreign manufacturers to register their medical device with the MDA. Additionally, all foreign manufacturers must now obtain Conformity Assessment Body (CAB) certification in order to receive MDA approval for their product registration application.

What are the different regulatory classifications for medical devices?

Medical devices in Malaysia are classified into 4 risk classes:

  • Class A: Minimal risk (blood pressure cuffs, scissors, etc.)
  • Class B: Low to moderate risk
  • Class C: Moderate to high risk (moderate to high risk)
  • Class D: Highest risk (implantable devices/devices that significantly affect the physiology of the human body)

Correct classification of devices is the most important step in the regulatory strategy process, which is especially important in Malaysia due to their rapidly evolving regulatory system. In mid 2016, the Malaysia MDA implemented a formal classification system.

What does the registration pathway look like for each regulatory classification?

To register a medical device product in Malaysia, first, the applicant should confirm a classification of the product based on the Medical Device Authority (MDA) classification. They are classified into 4 classes: A, B, C, and D in Malaysia. The registration routes vary based on the classification of the device.

For Class A devices (low-risk devices),  the applicant submits the application directly to MDA. The MDA review process takes about 2-3 months. The MDA fee is about $25 (USD) per application.

For Class B devices or above (higher-risk devices), the application needs to submit an application to a local, accredited conformity assessment body (CAB), before proceeding with the submission to MDA. The CAB conducts technical assessment, which is a prerequisite for successful registration with MDA. The CAB assessment would take about 3-4 months to complete. The CAB fee is about $300 (USD) per application.

Then, the applicant will proceed with the MDA submission (attaching the CAB assessment report to the application). The MDA review process takes about 3-6 months, after the CAB stage. The MDA fee is about $270 – $1,200 (USD) per application, depending on the classification of the product.

In June 2022, the MDA released the inaugural version of the guideline outlining the re-registration procedure for registered medical devices. The process consists of two stages. In Stage 1, the applicant submits the conformity assessment application, which is evaluated by the conformity assessment body (CAB). Following this, in Stage 2, the applicant proceeds with the re-registration application through the MeDC@St application system.

Each medical device is initially registered for a period of 5 years and must undergo re-registration before it can be reintroduced to the market.

The guideline encompasses all medical device classes, with varying application and registration fees for each class.

What are the document requirements for registration in Malaysia?

The medical device registration form requires the following components:

  • General information on the medical device
  • Information on manufacturer of medical device
  • Grouping of medical device
  • Common Submission Dossier Template (CSDT)
  • Post-market vigilance history
  • Declaration of conformity
  • Attestation for medical device registration

Is local testing (type testing/sample testing) required for registration?

No, local testing is not required for medical device registration in Malaysia.

Are clinical studies required for registration in Malaysia?

No, clinical studies are generally not required for registration in Malaysia.

Is approval in the Country of Origin required for registration?

No, Malaysia does not currently require approval in the Country of Origin for the registration of medical devices.

If you are ready to begin your medical device registration process in Malaysia, please contact us today.

Related Resource

Visit our Resource Center to view free webcasts and charts or read publications, news, and research reports on the Asia medical markets.

Related News Briefs

Visit our Resource Center to view free webcasts and charts or read publications, news, and research reports on the Asia medical markets.