Malaysia Medical Device Regulatory Update 2025-2026: A Review

1. Key takeaways

Four changes dominate the Malaysian device landscape across 2025 and 2026, and they do not affect the same part of the lifecycle. Class A fees were reformed under P.U.(A) 330, with an application fee of RM500 and a registration fee of RM750 from 1 January 2026. A new verification pathway took effect on 11 March 2025 under Circular 1/2025, revoking Circular 2/2014. The import licence mandatory date moved from 2 January 2026 to 1 July 2027. And automated renewal opened on 13 July 2026.

Read together, the four changes point in one direction: the regulator is moving routine transactions onto rules that reward a clean file and a predictable record. Companies that treat the changes as separate administrative updates will absorb them one at a time; companies that read them as a single shift will redesign their filing calendar once.

• Class A fee reform: P.U.(A) 330, effective 1 January 2026, application fee RM500 plus registration fee RM750.
• Verification pathway: Circular 1/2025, effective 11 March 2025, replacing Circular 2/2014.
• Supporting guidance: MDA/GD/0068 for the CAB side and MDA/GD/0070 for the establishment side.
• Recognised approvals: the list includes Australia, Canada, the EU, Japan, the US and the UK.
• Import licence deferral: mandatory date moved from 2 January 2026 to 1 July 2027; voluntary submission of the verification form opens 1 June 2026.
• Automated renewal: available from 13 July 2026 for certificates with no changes and clean records, subject to seven eligibility conditions.
• Also on the watch list: the 2023 JKTP decisions on QMS and traceability, the 2024 JKTPP decisions on classification and registration, and the 2024 export-only exemption order.

2. Legal basis

The fee change is made by subsidiary legislation: P.U.(A) 330 was gazetted on 11 September 2025 and the new fee position applies from 1 January 2026. The verification pathway is a policy instrument: Circular 1/2025 replaced Circular 2/2014 with effect from 11 March 2025, and its implementation was announced by the MDA on 26 March 2025. The import licence position was announced on 1 December 2025. The automated route is described in the Automated Re-Registration Guide of 10 July 2026 (Rev. 2).

Each instrument has a different legal character, which matters when a company has to decide what is binding and what is procedural. A gazetted order changes the fee. A circular changes the evidential route to a decision. A guide describes how a process operates. Confusing the three produces either unnecessary conservatism or unwarranted confidence.

3. Expert insights

Insight 1: the fee change is small in amount and large in signal.

An application fee of RM500 with a registration fee of RM750 for Class A is a modest charge in absolute terms. Its importance lies in what it says about the direction of travel: the lowest-risk category now carries a defined fee structure rather than sitting outside the schedule. Companies with broad Class A portfolios should recalculate the cost of portfolio maintenance, because the change multiplies across a product list, and they should confirm the position against the MDA’s current publication rather than a remembered figure.

Insight 2: the verification pathway is a leverage instrument, not a shortcut.

Circular 1/2025 systematises the rule that a recognised national approval plus a simplified assessment can support a Malaysian filing, and it does so through two guidance documents: MDA/GD/0068 for the CAB side and MDA/GD/0070 for the establishment side. The dual structure is the point. The pathway only works where both the assessor and the applicant understand the same evidence standard. Recognised approvals from Australia, Canada, the EU, Japan, the US and the UK are the currency; how well the dossier is assembled determines the exchange rate.

Insight 3: the deferral is preparation time, not free time.

The mandatory date for the import licence moved from 2 January 2026 to 1 July 2027, and the MDA explained the reason: to allow companies to complete preparation of systems, SOPs and personnel. Voluntary submission of the verification form opens on 1 June 2026. The distinction between voluntary and mandatory is where most value sits. Companies that use the voluntary window will discover the gaps in their systems while there is still time to close them; companies that wait for the mandatory date will discover the same gaps with a deadline attached.

Insight 4: automated renewal converts renewal from assessment into confirmation.

For certificates with no changes and clean records, the automated route removes the standard review and turns renewal into an eligibility confirmation, subject to seven conditions. That is a substantive change in the economics of the lifecycle, because it rewards the behaviour the rest of the framework demands: notifications filed when changes occur, records kept aligned and no open items left behind. A company with a neglected file does not merely lose the fast route; it signals, at the moment of renewal, that its change control has not been operated.

Insight 5: the items outside the four headline changes are the ones that surprise.

The 2023 JKTP decisions on QMS and traceability, the 2024 JKTPP decisions on classification and registration, and the 2024 export-only exemption order do not attract the same attention as a fee change, but they alter substantive requirements. A quarterly review of MDA announcements is a low-cost way to keep them visible. The alternative is to encounter them for the first time inside an assessment.

Insight 6: treat the update list as a changelog with owners.

Each change carries an effective date and an affected part of the lifecycle, and the articles on fees, change notification, renewal and import licensing are the places where the effect is felt. A standing quarterly review, with each item backfilled into the relevant procedure and the revision date updated, turns regulatory monitoring from an individual’s memory into an organisational record.

4. Practical recommendations

• Recalculate Class A portfolio costs. Apply the RM500 application fee and RM750 registration fee across the full product list and confirm against the current publication.
• Map the portfolio against the recognition list. Identify which products hold approvals from Australia, Canada, the EU, Japan, the US or the UK, and assess them for the verification route.
• Use the voluntary window from 1 June 2026. Submit the verification form early and treat the exercise as a systems test.
• Complete SOP and personnel preparation before 1 July 2027. The deferral is a preparation period with a fixed end.
• Audit renewal eligibility now. Check the seven conditions, close any open change notifications and confirm that records are consistent.
• Schedule the quarterly announcement review. Give one person the task, with a written output and a backfill action for each affected procedure.
• Record the effective date alongside each change. A requirement that has been published but not yet commenced is a planning input, not a current obligation.

5. Verification checklist

• □ P.U.(A) 330/2025 reviewed, gazetted 11 September 2025, effective 1 January 2026
• □ MDA announcement on Circular 1/2025 implementation (26 March 2025) reviewed
• □ MDA announcement on the import licence implementation date (1 December 2025) reviewed
• □ Automated Re-Registration Guide (10 July 2026, Rev. 2) on file
• □ MDA website Industry page checked for the 2023 JKTP and 2024 JKTPP decisions
• □ Recognition list confirmed for Australia, Canada, the EU, Japan, the US and the UK
• □ Fee, verification, import licence and renewal impacts assigned to procedure owners

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