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Product Classification

• Guideline:  Product Classification Application
• Application Form: Product Classification Application Form
•  Medical Device-Drug-Cosmetic Interphase (MDDCI) Table I
• For submission or any inquiries, please email to classification [AT] mda [DOT] gov [DOT] my
• Officer Incharge:

  • Pn Nur Athirah - +603 8230 0385 
  • Pn Che Rosmani - +603 8230 0371
  • Pn Aidahwaty - +603 8230 0341


Latest updates:
In order to prevent email deliverability issues due to platform migration of myGovUC email to a new platform, please submit your application to classification [AT] mda [DOT] gov [DOT] my


Product Classification is not intended to determine the Risk and Rules Classification of the medical devices.
Additional Information on Submission of Product Classification Application:


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 March 2023


  Medical Device Authority (MDA),
Ministry of Health Malaysia,
Level 6, Prima 9, Prima Avenue II,
Block 3547, Persiaran APEC,
63000 Cyberjaya, Selangor, MALAYSIA

  +603 - 8230 0300
  +603 - 8230 0200 
  mdb [AT] mda [DOT] gov [DOT] my

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  • Last Modified: 31 March 2023.
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