Malaysia’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?
There are 3 basic steps to registration:
- Foreign manufacturers need to appoint an Authorized Representative (AR) in Malaysia, who will register their devices.
- The AR will act as the foreign manufacturer’s local agent (license holder) during the registration process and after registration approval. The AR also handles mandatory post-market surveillance activities.
- The AR could be (1) your own subsidiary office in Malaysia, (2) a Malaysian distributor, or (3) an independent third party such as Pacific Bridge Medical.
- The advantage of appointing an independent third party AR is that sensitive technical information is kept confidential and is not shared with distributors.
- The AR prepares the registration application Common Submission Dossier Template (CSDT) based on the technical information from foreign manufacturer and submits it to the Malaysian Medical Device Authority (MDA) through an online system.
- An independent Conformity Assessment Body (CAB), which needs to be different from the one engaged by the foreign manufacturer in other countries, reviews the same registration application dossier and then issues a CAB certificate that is submitted to the MDA.
- The MDA will not approve the product until a CAB certificate is obtained.
- If the manufacturer can demonstrate evidence of compliance (e.g. the device is recognized) in the US, EU, Australia, or Canada, then the CAB review process will be simplified.
Previously, a major problem the MDA experienced was that they did not specify which documents the CAB needed to review. Thus, no devices were receiving approval, and it could have taken several months or even a few years for the MDA to develop an efficient registration approval system. To remedy this problem, the MDA created a “transition list.”
- If a manufacturer (through their AR) submitted a registration application dossier for their device to the MDA by June 30, 2016, then their device would be placed on the “transition list” and can be imported and sold in Malaysia after July 1, 2016 even without registration approval.
- If a manufacturer (through their AR) submits a registration application dossier after June 30, 2016, they cannot sell their device in Malaysia until after the product receives registration approval.
- Generally, the products on the transition list will be approved first before products that are not on the transition list. Due to the major backlog of applications the MDA and the CABs have to review, the registration process for new devices could take up to a few years. It is highly recommended that foreign manufacturers interested in selling devices in Malaysia begin the registration process as soon as possible.
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.
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