Faq

Frequently Asked Questions

Malaysia uses a rule-based classification system from Class A (lowest risk) to Class D (highest risk). Classification depends on the intended purpose, duration of contact and invasiveness of the device, not simply on what the device looks like.

Classification is the first deliverable of every engagement because it determines the applicable regulatory pathway, evidence requirements, fees and expected timeline.
The Common Submission Dossier Template (CSDT) is the technical dossier format accepted by the MDA for medical device registration.

It covers areas such as device description, essential principles conformity, labelling, risk analysis and clinical evidence. We prepare the CSDT using your existing technical files, test reports and supporting documentation.
Class B, C and D medical devices generally require conformity assessment by a registered Conformity Assessment Body (CAB) before the MDA registration application.

Class A devices are exempt from CAB assessment. We help prepare the required documentation and support the conformity assessment process where applicable.
Medical devices must generally be registered before being placed on the Malaysian market. Placing an unregistered medical device on the market is an offence under Act 737. Importation for demonstration, clinical evaluation or other specific purposes may be subject to separate regulatory requirements.

Contact us before shipping or marketing an unregistered device so we can assess the applicable regulatory pathway.
Existing CE marking, FDA clearance or other international approvals can provide valuable supporting evidence for the regulatory dossier.

However, these approvals do not automatically replace Malaysian MDA registration requirements. Your existing technical documentation can often be reused to support the Malaysian submission, reducing duplication of work.
Medical Device Regulatory Consulting