Malaysia’s Medical Device Authority (MDA) has issued an announcement optimising the Product Classification Application System (PCAS) and formally introducing validity-period management for Product Classification Letters.
The update took effect on 1 October 2026 and covers adjustments to the application form, the validity period of classification letters, renewal requirements and a streamlined application process.
1. PCAS application system update
To improve the efficiency of classification applications, MDA has updated PCAS and removed the requirement to submit the Product Classification Template. From 1 October 2026, applicants no longer need to upload the template separately when filing a classification application.
The relevant information has been incorporated into the PCAS online application form, so applicants can complete it directly within the system.
2. Validity period of product classification letters
From 1 October 2026, all newly issued Product Classification Letters are valid for five years.
The exact validity period is stated on the letter itself.
3. Transitional arrangements for existing letters
MDA has set out the following rules for the different situations:
| Status of the classification letter | MDA requirement |
|---|---|
| Newly issued letter | Valid for 5 years |
| Letter already issued with a 2-year validity | Automatically extended to 3 years from the original issue date; no separate application required |
| Letter that has already exceeded 5 years | A 1-year transition period applies; a renewal application may be submitted |
| Not renewed by the end of the transition period | The letter lapses and a new application is required |
4. Renewal requirements
MDA specifies that renewal is only available where the original information remains unchanged.
On renewal, the product scope, intended use, product description and manufacturer information must be identical to those in the original letter.
If any of this information changes — for example, a new product is added, the product description is revised, the intended use changes or the manufacturer changes — renewal cannot be used and a new classification application must be submitted.
5. Streamlined application flow
- After the applicant submits an application through PCAS, the system automatically sends an application notification; once MDA receives the application it issues a payment advice, with the invoice normally generated within 7 working days.
- After payment is completed and the complete documentation has been submitted, MDA starts the review, which takes 30 working days. If additional information is required during the review, the applicant must submit it within the specified period.
- If the review is satisfactory, MDA issues the Product Classification Decision Letter and notifies the applicant by email; if the requirements are not met, the application is rejected by system notification. If the applicant does not submit the requested information or does not respond within 90 working days of an information request, the application is withdrawn and will not be processed further.
6. Application fees and review period
The following fees and timelines apply to product classification applications:
| Item | Requirement |
|---|---|
| Product classification application fee | RM300 per application |
| Invoice generation | Within 7 working days |
| Review period | 30 working days |
| When the review starts | Once payment is completed and the documentation is complete |
7. What this means for medical device companies
Following this MDA update, companies registering medical devices in Malaysia should pay particular attention to the following points:
1. Track the validity of classification letters
Companies should confirm the status of existing classification letters in good time so that an expired letter does not disrupt later registration work.
2. Re-apply when product information changes
If the product, intended use, product description or manufacturer information changes, a new classification application must be submitted.
3. Prepare supplementary documents in advance
When MDA requests additional information, respond within the specified period so that the application is not withdrawn.
Grzan’s own Malaysian company, GRZAN GROUP SDN. BHD., provides one-stop medical device registration and authorised representative services in Malaysia. Please contact us if you have any questions.