MDA renewals: miss the date and you start again from zero.

Two clocks, two different rules.

Device re-registration: the one-year window

Regulation 6(3) of the Medical Device Regulations 2012 keeps a device on the Register for five years from the date of registration. Renewing it is re-registration, done in MeDC@St 2.0+. MDA's announcement (initial release 17 May 2024, Rev 1 on 5 June 2025) sets the mechanics:

• The re-registration function becomes available exactly one year before the certificate's expiry date.
• The system automatically deactivates the certificate when it expires.
• After expiry it accepts no re-registration at all, including applications drafted before expiry but not submitted.
• The only route back is a new registration subject to full conformity assessment under Act 737.

MDA also tells establishments to plan re-registration and change notifications well ahead. That matters more since July 2026, because a pending change notification now blocks the faster route below.

The Automated Re-Registration Route (from 13 July 2026)

MDA's submission guide (Revision 2, dated 10 July 2026) introduced an automated route in MeDC@St 2.0+ for applications submitted on or after 13 July 2026. Eligible registrations skip the standard evaluation route; the registration number does not change and the new validity continues from the previous certificate. MDA says there is no prescribed review timeline: it depends on the applicant completing the steps.

Eligibility: every box must be ticked

1. A valid Manufacturer or Authorised Representative licence.
2. No active Change Notification (CN) or Change of Ownership (COO) application for the device.
3. The certificate is active and within one year of expiry.
4. The device was registered via full conformity assessment or the verification route, and the CAB certificate is valid (an expired one can be replaced with a recertification certificate in the form).
5. No rejection, suspension or cancellation status.
6. Every field matches the latest information MDA approved.

What you may (and may not) update

The practical consequence: clear every CN before the one-year window opens. A CN still pending in month 11 pushes you back onto the standard route at the worst possible time.

What MDA charges, and what we charge

Re-registration pays the same Fifth Schedule fees as a first registration, as amended from 1 January 2026 by P.U. (A) 330/2025:

Our renewal fee is RM6,000 per registration, every 5 years, all-in — document updates, CAB and MDA fees and query follow-up. Renewal fees for every approval we manage are on the pricing page.

Establishment licence renewal: every 3 years

An establishment licence is valid for three years from issue (regulation 12(3)) and three years from each renewal (regulation 13(5)). Section 24(1) of Act 737 reads that a licensee may apply for renewal “not later than one year before the expiry date”; MDA's published licence condition says renewal is applied for not later than 90 days before expiry. The renewal fees, paid direct to MDA:

Since 1 July 2024 each role needs its own licence, and older multi-role licences are split at renewal, so budget the fee per role. The licence also rests on a valid GDPMD (or ISO 13485) certificate: our renewal engagement pairs the GDPMD re-certification with the licence renewal for our fee of RM5,500, with the CAB audit (RM4,785 per warehouse) and the MDA fee above paid direct. Details on the establishment licence page.

If it lapses, section 25 requires the establishment to stop importing, exporting and placing devices on the market immediately, with no compensation. Carrying on is punishable by a fine of up to RM200,000, imprisonment of up to 3 years, or both. MDA can also refuse renewal for contraventions of the Act, breach of licence conditions, an improperly obtained licence or a conviction (section 24(2)).

A renewal calendar that does not depend on memory

1. Month −15: list every registration and licence with its expiry date, role and CAB certificate expiry.
2. Month −14 to −12: file and close any pending change notifications; renew QMS and CAB certificates that will lapse.
3. Month −12: re-registration window opens: submit on the automated route where eligible. Start the establishment licence renewal file.
4. Month −6: anything not yet approved is escalated, never left to the final quarter.

Foreign manufacturers: the registrations sit with your authorized representative, so the calendar is theirs to run. Ask to see it. For the Act itself, our sister site has a plain-English guide to the Medical Device Act 2012 (Act 737).