Review timelines in Malaysia vary by device classification.
Frequently Asked Questions
When do we need to pay application and registration fees?
Consultation fee is based on progress payment by project stages. Certification Body (CAB) audit & product verification fee is payable before issuance of certificate.
For product registration, following terms apply:
– Application fee is due upon submission of application to MDA.
– Registration fee is due upon approval of application.
Are there any local labeling requirements?
Yes, the MDA registration number and contact information of the Malaysia AR must be included. Additionally, labeling for lay-use devices must be in Bahasa-Malay (and may also include English).
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 devices with the MDA. Additionally, all foreign manufacturers must 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 (hospital beds, surgical intruments, etc.)
- Class B: Low to moderate risk (syringe with needle, blood collection tube, etc)
- Class C:Moderate to high risk (dental x-ray machine, foam dressing, etc.)
- 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 its 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 registration 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 Kazami Group.
- 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 reviews all technical information from foreign manufacturers 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.
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 the 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
Are Clinical Studies Required For Registration In Malaysia?
No, clinical studies are generally not required for registration in Malaysia.