Malaysia: MDA Sets 2-Year Validity Period for Product Classification Letters (w.e.f 1 May 2025)

The Medical Device Authority (MDA) has announced a key regulatory update that impacts all stakeholders within the medical device and diagnostic industry.

Effective 1 May 2025, all newly issued Product Classification Letters (PCLs) will carry a validity period of up to two years from the date of issuance. This move aims to streamline classification processes, align with evolving regulatory standards, and strengthen industry compliance.

Previously, Product Classification Letters were issued without an expiry period. However, to maintain up-to-date regulatory practices and ensure consistency across the industry, MDA is now formalizing the classification lifecycle.

If you have previously obtained a Product Classification Letter, review your issuance date and take note of its new validity status. You are encouraged to plan ahead and ensure any necessary reclassification applications are submitted before your current letter expires.

You may reach the Classification team at classification@mda.gov.my.

Stay tuned for more detailed guidance and for enquiries please contact us at info@arqon.com

Source: Medical Device Authority (MDA)