In Malaysia, the classification of medical device must be carried out by the manufacturer in accordance with the prescribed manner, based on the level of risk, intended use, and the vulnerability of the human body as stated in Section 3(1) of Act 737. In the event of a dispute between the manufacturer and the Conformity Assessment Body(CAB) regarding the classification of a medical device, the matter must be referred to the authority (MDA) for a decision, in the manner and within the time frame specified by the authority.
In this regard, on March 25, 2025, the Malaysian Medical Device Authority (MDA) announced that starting from May 1, 2025, the product classification application process will be fully implemented online through Google forms.
The goal of this transition to an online procedure is to streamline the product classification process, enhance efficiency, and improve the overall experience for applicants.
Starting from May 1, 2025, product classification applications must be submitted through the designated Google forms. Upon approval, the official Product Classification Letter will be sent directly to the email address provided in the application form.
With the transition of the product classification application and issuance process to an online system, a validity period will now be applied to Product Classification Letters. The validity period will be based on the issuance date of the classification letter and is as follows:
| Date of Product Classification Issuance | Validity Status |
| On or before 31 May 2023 | The letter is no longer valid. A new application is required (if necessary) |
| Between 1 June 2023 and 31 May 2025 | The letter remains valid until 1 May 2027 |
| After 31 May 2025 | The letter will be valid for up to two (2) years from the issuance date |
| Starting 1 May 2027 | A new Product Classification Letter framework will take full effect |
Please refer to the link below.
PENGUMUMAN PERALIHAN KEPADA PROSES PERMOHONAN PENGKELASAN PRODUK SECARA DALAM TALIAN
PENGUMUMAN PERALIHAN KEPADA PROSES PERMOHONAN PENGKELASAN PRODUK SECARA DALAM TALIAN
www.mda.gov.my
ANNOUNCEMENT ON IMPLEMENTATION OF VALIDITY PERIOD FOR PRODUCT CLASSIFICATION LETTER
ANNOUNCEMENT ON IMPLEMENTATION OF VALIDITY PERIOD FOR PRODUCT CLASSIFICATION LETTER The Medical Device Authority (MDA) wishes to inform all industry stakeholders of an important update regarding the Product Classification Letter. Effective 1 May 2025, all
portal.mda.gov.my
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