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Malaysia: MDA Released Second Edition Guidance Documents for Product Classification

On February 2023, Malaysia’s Medical Device Authority (MDA) released a guidance document for the requirements of Product Classification. This guidance document is a revised version of MDA/GL/06 that was released in October 2021,that provides guidance, reference, and clarification on how to apply for Product Classification that are regulated under the Medical Device Act (Act 737).

This document is applicable to establishments, healthcare facilities, and public dealing medical device and non-medical device products. The revised guideline document covers the following matters:

1. Revision on the Section 4- Application Procedure

a. An official email for submission has been changed to

b. Revision on the required supporting documents to be submitted.

c. Time frame for processing application form based on the complexity of the device is 30 working days.

2. Revision on the Annex A Product Classification Application Form.

Further information on the released Second Edition Guidance Documents For Product Classification, please refer to this link.

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