• Product Classification Application

To determine whether the product is classified as a medical device or non-medical device product by the definition of medical device under Act 737

*Note:-
Product Classification is not intended to determine the Risk and Rules Classification of the medical devices.

  •  Guideline on How to Apply for Product Classification: Product Classification Application
  • Application Form:Product Classification Application Form (Handwritten Forms are not accepted) 
  • Reference Documents upon the classification of products:
    1. Medical Device-Drug-Cosmetic Interphase (MDDCI) Table I
    2. Classification of Rehabilitation, Physiotherapy and Speech Therapy Device 
    3. Harmonised Borderline Products in ASEAN 
    4. List of Non-Medical Device Products 2022-2023 
    1. Nur Athirah - +603 8230 0385 
    2. Che Rosmani - +603 8230 0371
    3. Nur Syafura - +603 8230 0352
    4. Aidahwaty - +603 8230 0341

 

Flowchart 2023

 

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.  

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) 

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)

 

 Updated: 29 February 2024