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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@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)

Print

  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@mda.gov.my

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  • Last Modified: 30 November 2021.
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