On April 8, 2025, the Medical Device Authority (MDA) of Malaysia released two important regulatory updates to enhance efficiency, strengthen compliance, and improve the overall submission process for product classification. These updates are effective starting May 1, 2025.
The first update mandates the full transition to online submission for product classification applications. The second introduces a validity period for Product Classification Letters to ensure consistency with regulatory expectations.
Key Highlights
Transition to Online Submission (Effective May 1, 2025)
- All product classification applications must be submitted exclusively via the designated Google Form (Product Classification Application Form).
- Manual submission methods (email or hardcopy) will no longer be accepted.
- Official Product Classification Letters will be sent via email to the applicant. Hard copies will not be issued.
- Stakeholders are encouraged to familiarize themselves with the new process ahead of the implementation date.
Implementation of Validity Period for Product Classification Letters (Effective May 1, 2025)
A newly issued Product Classification Letters will be valid for up to two years to align with regulations and improve compliance, with a transition plan based on the letter’s issuance date (as detailed in the following table).
Date of Product Classification Issuance | Validity Status |
On or before 31 May 2023 | The letter is no longer valid. A new application is required if necessary. |
Between 1 June 2023 and 31 May 2025 | The letter remains valid until 1 May 2027. |
After 31 May 2025 | The letter will be valid for up to two (2) years from the issuance date. |
Starting 1 May 2027 | A new Product Classification Letter framework will take full effect. |
Applicants should be aware of the new validity period for Product Classification Letters and take timely action on any required regulatory processes before their existing letters expire; further information will be available on the MDA website.
Implications to Clients:
Clients must ensure the following:
- Timely adoption of the new online application process beginning May 1, 2025.
- Accuracy in providing email addresses to receive digital Product Classification Letters.
- Awareness of the updated validity periods and take necessary actions to renew or reapply if required to maintain regulatory compliance.
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