Class C and Class D Medical Device Registration in Malaysia: Process and Timelines

1. Key takeaways

Class C and Class D follow the same four-element structure as Class B, but the depth of assessment rises with risk. These classes typically involve a more comprehensive QMS audit, potentially including an on-site audit arrangement, and a stricter technical documentation review. Official fees are also higher: for Class C, an application fee of RM500 plus a registration fee of RM2,000; for Class D, an application fee of RM750 plus a registration fee of RM3,000. The process runs through four stages, from preparation to post-issuance maintenance, and the registration certificate remains valid for five years, with change and renewal management required throughout that period. The practical consequence is that C and D projects must be planned as programmes rather than transactions.

• The four elements are QMS, PMS, TD and DoC, assessed to a depth that increases with the device class.
• C and D normally attract a broader QMS audit, with the possibility of an on-site audit being scheduled.
• Official fees are RM500 plus RM2,000 for Class C, and RM750 plus RM3,000 for Class D.
• The four stages are preparation, CAB assessment, MDA registration, and issuance and maintenance.
• The registration certificate is valid for five years, after which change control and renewal must be managed.
• MDA and CAB internal service targets are in the region of 30 working days each for verification-type review and MDA registration, subject to the commitments in force at the time.
• A full assessment path carries no uniform timeline commitment, so actual duration is driven by the number of deficiency rounds.

2. Legal basis

The assessment obligations derive from the Third Schedule to the Medical Device Regulations 2012, which applies the four-element structure across classes B, C and D while leaving the intensity of examination to the risk classification. Section 7 of Act 737 provides the registration obligation that follows a satisfactory assessment. MDA/GL/MD-01 sets out how applications are prepared and reviewed, including the circumstances in which a file may be returned or registration refused. The service expectations referred to in practice come from the MDA document titled CAB Guide for Conducting Conformity Assessment by Way of Verification, issued in 2025, which contains the 30 working day order of magnitude reference for verification-type review. That figure is a target reference, not a statutory deadline, and the guide itself points to the commitments in force at the time of submission. Fees are prescribed in the Fifth Schedule, with the Class C and Class D amounts stated separately from the Class B amount. Because the schedule fixes the official component only, CAB charges remain a matter of commercial quotation.

3. Expert insights

Three categories of deficiency account for most of the delay at Class C and Class D. The first is insufficient clinical evidence, judged against the performance evaluation requirements in item 11 of the EPSP. At this level, a general statement that the device performs as intended is not sufficient; the clinical evidence must connect the claimed performance to the specific device and its intended use. The second is an incomplete chain linking risk management, biocompatibility and sterilization validation. Reviewers follow that chain from hazard identification through to the validation report, and a break anywhere along it, such as a biocompatibility assessment that does not address a material in the final finished device, produces a deficiency that can take a full round to resolve. The third is inconsistency between labelling claims and the registered intended use, which is a documentary failure rather than a technical one and is therefore the most easily avoided.

The absence of a uniform timeline commitment on the full assessment path is not a loophole; it reflects the fact that duration is a function of file quality. Each deficiency round adds a full cycle of preparation, response and re-review, and the rounds compound when responses are partial. Manufacturers who plan for a fixed calendar period without accounting for rounds tend to compress the preparation stage, which is the one stage where compression reliably produces more rounds later. The reverse approach, investing in preparation and pre-review, moves work from the least controllable part of the process to the most controllable part.

A pre-submission review is the single most effective control available at this level. Having a third party with CAB review experience read the CSDT before formal submission typically removes one or two deficiency rounds, and the timeline benefit far exceeds the cost of the review. The exercise is not a proofread. It is a structured test of whether each claim in the dossier is supported, whether the four elements tell a consistent story, and whether the classification and grouping decisions would survive a challenge from a reviewer approaching the file without prior context.

4. Practical recommendations

• Build the project plan around the four stages, with explicit decision points between preparation, CAB assessment, MDA registration and maintenance.
• Commission a pre-submission review of the CSDT by a party with CAB review experience, and budget the time to act on its findings before submission.
• Test the clinical evidence against item 11 of the EPSP claim by claim, rather than relying on a general performance narrative.
• Trace the risk management, biocompatibility and sterilization validation chain end to end, confirming that each link addresses the final finished device.
• Reconcile every labelling claim with the registered intended use, and remove rather than defend any statement that exceeds it.
• Ask the CAB in advance whether an on-site audit is likely for the device type, and prepare the QMS evidence on that assumption.
• Treat the 30 working day reference as a planning assumption subject to confirmation, and confirm current service commitments at the time of submission.

5. Verification checklist

• □ Third Schedule to the Medical Device Regulations 2012 has been reviewed as at 19 October 2026 for the four elements and assessment depth.
• □ Section 7 of Act 737 and MDA/GL/MD-01 have been checked for the registration obligation and review expectations.
• □ The MDA CAB Guide for Conducting Conformity Assessment by Way of Verification (2025) has been reviewed for the 30 working day order of magnitude reference.
• □ Fee calculations reflect RM500 plus RM2,000 for Class C and RM750 plus RM3,000 for Class D under the Fifth Schedule.
• □ Any timeline in the project plan is labelled as industry experience rather than an official MDA or CAB commitment.

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