Background
On 11 November 2025, the Medical Device Authority (MDA) announced an update on Product Classification Letters. From 1 May 2025 onwards, any newly issued classification letter will expire after a maximum of two (2) years. This change is introduced to ensure consistency with current regulatory frameworks and industry practices.
Transition Schedule for Product Classification Letters
The MDA also provided a detailed transition schedule to guide stakeholders through the implementation period:
| Date of Product Classification issuance | Validity Status |
| Before 1 January 2020 |
|
| Between 1 January 2020 and 31 December 2023 |
|
| Between 1 January 2024 and 31 May 2025 | Letter remains valid until 1 May 2027 |
| After 31 May 2025 | Letter valid for up to 2 years from issuance date |
| Starting 1 May 2027 | New product classification letter framework will take full effect |
Withdrawal of Previous Announcement and Stakeholder Action
Earlier announcement issued by MDA on 1 April 2025, regarding the validity of the product classification letter is withdrawn and shall not be relied upon. Therefore, all stakeholders are advised to review the updated announcement carefully and plan ahead to complete any regulatory requirements prior to the expiration of their product classification letters.
Managing product classification validity and renewals require careful regulatory planning. Our experts support you in assessing classification status, preparing renewal or re-application strategies, and maintaining compliance under the updated MDA framework.
With over 25 years of experience, Qualtech Consulting Corporation supports medical device manufacturers in navigating regulatory changes with confidence.
Connect with us today to ensure continued compliance and uninterrupted market access.
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