• Home
  • Industry
  • Product Classification

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 
• 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 


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 

Today 824 Yesterday 6666 Week 39264 Month 7490 Visitor Counter: 119840554

  • Last Updated: 01 December 2023.
Copyright © 2023 Medical Device Authority
Ministry of Health Malaysia
Best view with Firefox 64 and above, minimum resolution 1366x768