The Medical Device Authority (MDA) of Malaysia has issued an announcement regarding the implementation of a validity period for the Product Classification Letter, effectively revoking the previous announcement dated 1 April 2025.
To read the full announcement: Implementation of Validity Period for Product Classification Letter [link]
Key Updates
1. Introduction of Validity Period
As stated in the MDA announcement:
- Effective 1 May 2025, all newly issued Product Classification Letters will be valid for up to two (2) years from the date of issuance.
- This policy aims to ensure that product classifications remain aligned with current regulatory requirements and support improved industry compliance.
2. Validity Status Based on Issuance Date
According to the announcement, the validity of of Product Classification Letters based on their issuance date, is summarized as follows::
Date of Product Classification | Validity Status |
Before 1 January 2020 | No longer valid – a new application is required. |
Between 1 January 2020 – 31 December 2023 | No longer valid – renewal or reapplication is required. |
Between 1 January 2024 – 31 May 2025 | Remains valid until 1 May 2027. |
After 31 May 2025 | Valid for 2 years from the issuance date. |
Starting 1 May 2027 | A new Product Classification Letter framework will take full effect. |
The announcement further states that a new Product Classification Letter framework will take full effect starting 1 May 2027.
3. Required Actions for Establishments
The MDA advises all establishments to review the validity of their existing Product Classification Letters and plan accordingly to avoid potential delays in their product registration or renewal processes.
Stakeholders may contact the MDA Classification Team at 03-8230 0376 or email classification@mda.gov.my for further clarification.
Implications to Clients
Manufacturers are advised to verify the validity status of their current Product Classification Letters, particularly for products that have not yet been registered.
- Reapplication may be required for letters issued before 2024.
Effective Date
The implementation date for the new validity period is 1 May 2025.
For inquiries or support regarding the implementation of the new Product Classification Letter validity requirements, please contact sales@andamanmed.com or reach out to us for guidance in Malaysia.
