Class B Medical Device Registration in Malaysia: CSDT, CAB Assessment and Fees

1. Key takeaways

Class B devices cannot use the Class A notification shortcut. The route requires a Common Submission Dossier Template (CSDT), supporting documents and a Declaration of Conformity, followed by a conformity assessment performed by a Conformity Assessment Body (CAB) and then registration with MDA. The assessment is structured around four elements set out in the Third Schedule, and the CAB issues a report and a conformity certificate against each of them. Class B is not eligible for exemption from the CAB procedure, but the depth of assessment is lower than for Class C and Class D devices. In practice this means the same documentary architecture as the higher classes, with a narrower technical examination and a shorter engagement with the CAB.

• The pathway is CSDT plus supporting documents plus DoC, assessed by a CAB and then registered with MDA.
• The four assessment elements are quality management system (QMS) assessment, post-market surveillance (PMS) system assessment, technical documentation (TD) review, and verification of the Declaration of Conformity.
• The technical file follows the CSDT format described in Appendix 2 of the Third Schedule and in MDA/GD-03; the templates for general devices and for IVDs differ and must not be mixed.
• Official fees under the Fifth Schedule are an application fee of RM250 plus a registration fee of RM1,000, totalling RM1,250.
• CAB fees are separate and vary by body, so they must be quoted individually; the industry range of roughly RM15,000 to RM50,000 and above is indicative only.
• A valid approval from a recognised country allows the verification route under Circular 1/2025, in which the CAB verifies existing conformity evidence rather than performing a full assessment.

2. Legal basis

The assessment framework is established by the Third Schedule to the Medical Device Regulations 2012, which defines the four elements a CAB must address and identifies the CSDT as the technical documentation format. Appendix 2 of that schedule, read together with MDA/GD-03, describes how the dossier is structured, and it distinguishes between the general device template and the IVD template. The DoC is not a stand-alone document at this level: it is verified by the CAB as part of the assessment, which means its content must be traceable to the technical documentation rather than merely present in the file. Fees are prescribed in the Fifth Schedule, which sets the RM250 application fee and the RM1,000 registration fee. CAB charges are commercial and fall outside the schedule, so they are quoted separately by each body. The verification option derives from Circular Letter MDA No. 1/2025, which allows Class B, Class C and Class D devices holding approvals from recognised countries, including FDA 510(k), CE marking, TGA, Health Canada, MHLW and MHRA, to be assessed by way of verification of existing conformity evidence instead of a full assessment. The MDA list of registered CABs, updated on 30 November 2023, is the reference point for confirming which bodies are available for a given device type.

3. Expert insights

The four elements are not four documents; they are four questions that must be answered consistently. A QMS assessment asks whether the quality system actually governs the design, manufacture and release of the device in question. The PMS assessment asks whether the system generates and uses post-market information in a way that would detect a change in the benefit-risk profile. The TD review asks whether the evidence in the dossier supports the claims made. The DoC verification asks whether the declaration matches everything the other three elements have established. Files fail most often at the seams between these questions, for example when the TD describes a manufacturing process that the QMS audit did not observe, or when the DoC asserts a performance characteristic that the TD does not evidence.

For a first Class B submission, the choice of CAB is a substantive decision rather than an administrative one. A body with GDPMD experience and with prior reviews of similar devices will ask better questions earlier, and the quality of those questions determines how many rounds of deficiency response the file will need. A CAB encountering a device category for the first time tends to compensate with broader requests, which lengthens the cycle without necessarily improving the outcome. The practical test is not the fee quote alone but the body’s familiarity with the specific technology and with the Malaysian quality system requirements that sit behind the GDPMD arrangements.

The verification route changes the economics of Class B more than any other factor. Where a recognised approval already exists, the CAB is verifying evidence that has been assessed elsewhere rather than building a full assessment from the ground up, and the timeline compresses accordingly. That does not make the Malaysian requirements disappear. Classification, grouping, labelling language, AR and establishment licence arrangements, and PMS commitments all remain local obligations, and a verification opinion that rests on a certificate whose scope does not match the device will not survive scrutiny. Manufacturers who plan the verification route from the outset prepare the mapping between the foreign approval and the Malaysian dossier before the CAB is engaged.

4. Practical recommendations

• Select the CSDT template that matches the product type, general device or IVD, before drafting begins; retrofitting a dossier to the wrong template is more costly than starting correctly.
• Map each of the four assessment elements to a named owner and a specific section of the dossier, so that nothing depends on a single general submission narrative.
• Engage a CAB with GDPMD experience and prior review exposure to the same device category, and confirm the scope of its accreditation before signing.
• Request CAB fee quotations in writing and compare them against the scope of work, since the official fee of RM1,250 represents only the government component.
• Where a recognised country approval exists, check its scope against the device and prepare the verification mapping in advance of the CAB engagement.
• Reconcile the DoC against the technical documentation line by line before submission, treating any assertion without a corresponding evidence reference as a gap.
• Confirm the CAB remains on the MDA list at the time of submission, using the current published list rather than an older reference copy.

5. Verification checklist

• □ Third Schedule to the Medical Device Regulations 2012 has been reviewed for the four assessment elements and the CSDT requirement.
• □ MDA industry pages on conformity assessment and the Declaration of Conformity have been checked for current expectations.
• □ Circular Letter MDA No. 1/2025 has been assessed for verification eligibility and the applicable recognised approvals.
• □ The CAB appears on the MDA CAB list updated 30 November 2023, with accreditation covering the device type.
• □ Fee calculations separate the official RM250 and RM1,000 components from CAB charges, and CAB figures are marked as industry reference rather than official data.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support across Southeast Asia, including Malaysia. Our team prepares dossiers to ASEAN CSDT structure, manages submissions and deficiency responses with the MDA, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com