Class A Medical Device Registration in Malaysia: Notification and Declaration of Conformity

1. Key takeaways

Class A medical devices enter the Malaysian market through a notification route rather than a full conformity assessment. Under the Medical Device (Exemption) Order 2016, Class A devices are exempt from the conformity assessment procedure that a Conformity Assessment Body (CAB) would otherwise perform. Instead, the authorised representative (AR) or the manufacturer issues a Declaration of Conformity (DoC) and lodges a notification through MeDC@St. Once MDA accepts the notification, the device is listed in the register and may be placed on the market. The route is deliberately lighter than the Class B, C and D pathways, but it is not a formality: the exemption removes the CAB step only, not the underlying manufacturer obligations, and not the need for a defensible technical basis behind every statement in the declaration.

• The route combines notification with a self-issued Declaration of Conformity; no CAB certificate is required.
• The DoC is the core document, supported by basic product information such as name, intended use, classification rationale, and GMDN or HS codes.
• Where the device is sterile or has a measuring function, sterilization or measurement validation reports are normally expected, mirroring the A(S) and A(M) logic applied to IVDs.
• From 1 January 2026, the fee structure changes to an application fee of RM500 plus a registration fee of RM750, compared with the earlier application fee of RM100 and no registration fee.
• Manufacturer obligations under section 4 of Act 737 continue to apply in full, including EPSP compliance, GMP manufacture, and compliant labelling.
• Industry experience places a well-prepared Class A notification at roughly two to three months, with most of that time spent on the AR agreement, the DoC, and product information.

2. Legal basis

The exemption is created by the Medical Device (Exemption) Order 2016, which removes Class A devices from the CAB conformity assessment procedure while preserving the registration obligation itself. The procedural expectations sit in MDA/GL/MD-01, which describes how applications are prepared, submitted and reviewed, and which also sets out the circumstances in which an application may be returned or registration refused. Manufacturer duties are anchored in section 4 of Act 737, covering conformity with the essential principles of safety and performance (EPSP), manufacture under good manufacturing practice, and labelling that meets regulatory requirements. The fee change originates in the Medical Device (Amendment) Regulations 2025, cited as P.U.(A) 330, gazetted on 11 September 2025 and effective from 1 January 2026. That instrument restructures the Class A charge into two components: an application fee of RM500 and a registration fee of RM750. Before that date, the application fee was RM100 and no registration fee applied. Fees for Class B, C and D are unchanged by this amendment. Because the exemption order addresses the assessment step rather than the registration step, a Class A device still requires an AR established in Malaysia, a submission through MeDC@St, and an entry in the MDA register before it can be imported, exported or placed on the market.

3. Expert insights

The most common misconception about Class A is that low risk means low scrutiny. In practice, a lighter review burden is not the same as a lower standard. Section 4 obligations apply identically across classes, so a Class A manufacturer must still demonstrate conformity with the EPSP, manufacture under GMP, and label the device in line with Malaysian requirements. What changes is who performs the assessment and how much documentation is examined up front, not whether the underlying obligations exist. Reviewers who find a labelling statement, a promotional claim, or a DoC assertion that cannot be reconciled with the submitted product information have a straightforward basis for returning the file.

Rejection experience points to three recurring weaknesses at this level. The first is labelling and claims that reach beyond the intended use described in the DoC, a pattern that becomes visible as soon as the two documents are read side by side. The second is a DoC whose content does not meet the expected structure, for example a declaration that omits the classification rationale or fails to identify the device precisely. The third is product information that is too thin to support the classification itself, leaving the reviewer unable to confirm that Class A is the correct class. None of these failures requires a deep technical objection; each is a documentary mismatch, which is precisely why they are avoidable.

The 2026 fee change deserves separate attention from a portfolio perspective. Moving from a nominal application fee to a two-part application and registration charge raises the government cost of each notified SKU to RM1,250. For a manufacturer with a broad Class A catalogue, the aggregate effect is material, and it arrives at the moment of submission rather than being spread across the assessment cycle. That makes SKU grouping and necessity screening a commercial exercise as much as a regulatory one: decide which variants genuinely need separate registrations, which can be consolidated under a single grouping, and which are not worth carrying in the Malaysian market at all. Manufacturers who treat the fee change as a line item rather than a portfolio decision tend to over-file and then under-maintain.

4. Practical recommendations

• Confirm the class against the First Schedule before drafting anything; the entire notification route depends on a defensible Class A determination.
• Draft the DoC first and build the product information around it, so that intended use, classification rationale and claims remain consistent across every document.
• Check whether the device is sterile or has a measuring function, and prepare the corresponding sterilization or measurement validation report before submission rather than after a query.
• Align labelling and promotional material with the intended use stated in the DoC; treat any statement that exceeds it as a defect to be removed, not a point to be argued.
• Execute the AR agreement early, since it sits on the critical path for a route whose review time is otherwise short.
• Model the 2026 fee structure across the full Class A portfolio and group SKUs before filing, rather than submitting each variant as a separate cost event.
• Keep the notification file and the DoC under version control so that later changes can be traced and any post-market query answered from a single source.

5. Verification checklist

• □ Medical Device (Exemption) Order 2016 confirms the Class A exemption from CAB conformity assessment.
• □ Medical Device (Amendment) Regulations 2025 [P.U.(A) 330], gazetted 11 September 2025 and effective 1 January 2026, is reflected in the fee calculation.
• □ Section 4 of Act 737 obligations are addressed for EPSP, GMP manufacture and labelling.
• □ MDA/GL/MD-01 has been reviewed for submission expectations and return or refusal scenarios.
• □ The DoC, product information, and any sterilization or measurement validation report are internally consistent and version controlled.

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