Medical device registration in Malaysia
Malaysia offers one of Southeast Asia’s most robust and dynamic markets for foreign medical device manufacturers. To obtain market authorization in Malaysia, you must first register your product with the Malaysian Medical Device Authority (MDA). Registration with the MDA is done electronically through the web-based Medical Device Centralised Online Application System , and can only be done by the local Authorized Representative.
The Common Submission Dossier Template (CSDT) is the format required for the submission of required information to the MDA as part of the product registration application process in Malaysia. With more than 10 years’ experience in the medical field, our in-house experts are able to compile your technical documents and prepare customized dossiers such as the CSDT for medical device registration in Malaysia. We have a proven track record of completing dossiers efficiently with minimal questions and feedback received from MDA.
As an importer, distributor or authorized representative of medical devices in Malaysia, the regulations require compliance with the Good Distribution Practices for Medical Devices (GDPMD). Titans Medical are able to provide support to implement adequate and customized processes to comply with the GDPMD requirements. For local manufacturers looking to implement QMS for their business objectives, we also offer consultancy for ISO 13485:2016 certification. We are experienced in liaising with the conformity assessment body (CAB) for ISO 13485 implementation and certification
Titans extends auxiliary support for manufacturers with Device Classification, conformity assessment for certification and extends support throughout the Regulatory process. Titans helps foreign applicants to procure a suitable local agent with industry relevance. Titans, with long-standing experience, effectively handles the post-marketing surveillance activity of Medical Devices in Malaysia.
The Common Submission Dossier Template (CSDT) is the format required for the submission of required information to the MDA as part of the product registration application process in Malaysia. With more than 10 years’ experience in the medical field, our in-house experts are able to compile your technical documents and prepare customized dossiers such as the CSDT for medical device registration in Malaysia. We have a proven track record of completing dossiers efficiently with minimal questions and feedback received from MDA.
As an importer, distributor or authorized representative of medical devices in Malaysia, the regulations require compliance with the Good Distribution Practices for Medical Devices (GDPMD). Titans Medical are able to provide support to implement adequate and customized processes to comply with the GDPMD requirements. For local manufacturers looking to implement QMS for their business objectives, we also offer consultancy for ISO 13485:2016 certification. We are experienced in liaising with the conformity assessment body (CAB) for ISO 13485 implementation and certification
Titans extends auxiliary support for manufacturers with Device Classification, conformity assessment for certification and extends support throughout the Regulatory process. Titans helps foreign applicants to procure a suitable local agent with industry relevance. Titans, with long-standing experience, effectively handles the post-marketing surveillance activity of Medical Devices in Malaysia.
How to register for your medical device in Malaysia
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.
Titansmedical can help you with medical device or IVD registration, act as your Authorized representative and support you with distributor identification and importation.
