• Product Classification Application

To determine whether the product is classified as a medical device or non-medical device product by the definition of medical device under Act 737

Product Classification is not intended to determine the Risk and Rules Classification of the medical devices.

    1. Medical Device-Drug-Cosmetic Interphase (MDDCI) Table I
    2. Classification of Rehabilitation, Physiotherapy and Speech Therapy Device 
    3. Harmonised Borderline Products in ASEAN 
    4. List of Non-Medical Device Products 2022-2023 
    1. Nur Athirah - +603 8230 0385 
    2. Che Rosmani - +603 8230 0371
    3. Nur Syafura - +603 8230 0352
    4. Aidahwaty - +603 8230 0341


Flowchart 2023


Instant Guide to Product Classification Application


New Application of Product Classification Form


Section 1 – Applicant Information

Remark: Information on Section 1 are mandatory to fulfill¸ please fill in email address of the person in-charge or a few email addresses as backup email


Section 2 – Product Information

Part A – General Information

Remarks: Description of Product, Primary Intended purpose/indication, Primary Mode of action must be supported with supporting document as declared and provided by the manufacturer (Refer Section 3 – Supporting Documents)

Part B – List of Products (if applicable)

Remarks: To be filled in up if the application is more than 1 product. Only products with same intended use can be combined together in one application form (Maximum: 10 products per application form)

Part C – Information on the Product Formulation (if applicable)

Remarks: You may leave it blank if there is no specific ingredient or product formulation.  


Section 3 – Supporting Documents

         i.            Product label (indicating product name and manufacturer)

       ii.            Product leaflet / brochure (that contain description & intended use of the product)

     iii.            Other relevant documents: eg: Declaration of Conformation, Quality Management System (QMS) Certificate, Pre-market Approval

     iv.            Other information (please specify): eg: User manual, Instruction for use

Remarks: Only complete application with supporting document will be evaluated within 30 working days (after cleared payment) 


Section 4 – Applicant Declaration

Remark: Please fill in complete applicant declaration


After complete requirements set out in paragraph 4 have been fulfilled, invoice will be issued.

Remarks: The Product Classification Application Fees is RM300.00 per application form. Payment can be made via Bank Draft or Telegraphic Transfer/Direct Bank Transfer


Attachment 1

Remarks: To be filled in up if application is more than 1 product. Only products with same intended use can be combined together in one application form (Maximum: 10 products per application form) 


Medical Device-Drug-Cosmetic Interphase (MDDCI Table 1)

Remarks: This is a reference for the borderline of Medical Device-Drug-Cosmetic product for the identification whether the product falls under Medical Device Authority (MDA) or National Pharmaceutical Regulatory Agency (NPRA)


 Updated: 29 February 2024