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
*Note:-
Product Classification is not intended to determine the Risk and Rules Classification of the medical devices.
Additional Information on Submission of Product Classification Application:
Instant Guide to Product Classification Application
No. |
New Application of Product Classification Form |
1. |
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 |
2. |
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.
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3. |
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)
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4. |
Section 4 – Applicant Declaration Remark: Please fill in complete applicant declaration |
5. |
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 |
6. |
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)
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7. |
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