Malaysia’s Medical Device Authority (MDA) announced changes to its Medical Device Product Classification Application System (PCAS) and to how long product classification letters stay valid. The changes took effect on October 1.
The upgraded PCAS uses a simplified online form. Applicants now enter product details directly in the form instead of uploading a separate classification template. Then, the MDA generates an invoice within seven working days. The fee is 300 RM (73.39 USD) per application, and classification review takes 30 working days once payment clears and the file is complete. If the MDA asks for additional information and does not receive a response within 90 working days, it will withdraw the application and will not refund the fee.
Classification letters issued on or after October 1, 2026 are valid for five years, and the expiry date is printed on each letter. Classification letters issued earlier with two-year validity remaining are automatically extended to three years, with no action needed.
Holders of classification letters more than five years old have until October 1, 2027, to apply for renewal, including letters that have already expired. Renewal is only possible if the products, intended use, product description, and manufacturer details are unchanged. Any change, or the addition of new products, requires a new classification application.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.