Malaysia Medical Device Authority (MDA) announces two key changes to the Product Classification Letter process.

1. Fully Online Application Process
In line with its digital transformation efforts, MDA will fully transition to online submissions for product classification applications via Google Forms, effective 1 May 2025.
• All applications must be submitted online.
• Official letters will be emailed to applicants; no hard copies will be issued.
These updates are designed to streamline processing, reduce paper-based workflows, and ensure faster communication with applicants.

2. Validity Period for Product Classification Letters
Starting 1 May 2025, all newly issued Product Classification Letters will carry a validity period of up to two (2) years from the issuance date. This move ensures alignment with evolving regulatory requirements and encourages timely compliance.
Validity Based on Issuance Date:
• On or before 31 May 2023 – No longer valid; reapplication required if necessary.
• 1 June 2023 to 31 May 2025 – Valid until 1 May 2027.
• From 1 June 2025 onwards – Valid for two (2) years from the issuance date.
A new product classification framework will take full effect beginning 1 May 2027.

For more information you may access through the link:

https://portal.mda.gov.my/index.php/announcement/1536-pengumuman-peralihan-kepada-proses-permohonan-pengkelasan-produk-secara-dalam-talian
https://portal.mda.gov.my/index.php/announcement/1537-announcement-on-implementation-of-validity-period-for-product-classification-letter

Share on Linkedin Send to Email

Questions? Request more information from our specialists!

Contact Us

More News