Product Classification

• Guideline: Product Classification Application (Document under Revision)
• Application Form: Product Classification Application Form
Medical Device-Drug-Cosmetic Interphase (MDDCI) Table I
• For submission or any inquiries, please email to classification@mdb.gov.my
• Officer Incharge:
o Pn Aidahwaty - +603 8230 0341
o Pn Nashirah - +603 8230 0343
o En. Mohd Naquib - +603 8230 0209
o Pn Nur Athirah - +603 8230 0385
o En. Mohd Afdhal - +603 8230 0338

*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:

 

Flow Chart

 

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 – Information on the Product Formulation (If applicable)

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

Part C – Status of Product Classification in reference countries

Remarks: If the product has been imported / marketed in the reference countries, please fill in and provide supporting document. Please stated ‘Nil’ if the product does not been marketed in that country

 

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 completed application with supporting document will be evaluated within 14 to 21 working days (after cleared payment)

 

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)

 

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)

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