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APPLICATION FOR PRODUCT CLASSIFICATION PDF Print E-mail

APPLICATION FOR PRODUCT CLASSIFICATION

 

OBJECTIVE:  

To determine whether a product is Medical Device or non-Medical Device

CLASSIFICATION CRITERIA:

The following are the criteria to assess product classification:

a)  The primary intended purpose of the product,

b)  The primary mode of action/the principal mechanism of action by which the claimed effect or purpose of the product is achieved

i-    Medical Device is based on function by physical means eg; mechanical action, creation of a physical barrier or replacement or support of organ or body                 function,

ii-   Drug is based on pharmacological, immunological or metabolic action in/on the body.

c)    Active ingredient, indication and pharmaceutical dosage form (those are the main criteria for classification of the drugs);

d)    Classification of the product/combination product or similar product/similar combination product in the reference countries. The reference countries are US,                     EU, Canada, Australia and Japan.

 

The primary mode of action/the principal mechanism of action may be deduced from the scientific data and the manufacturer’s labelling and claims. The claims made for a product, in accordance with its mode of action may represent an important factor for its qualification as a medical device.

 

STEPS FOR APPLICATION:

Please refer to the Flowchart for Product Classification Application. (CLICK HERE ).

 

APPLICATION FORM:

Local companies wishing to apply for Product Classification, please CLICK HERE  for the application form.

ANNOUNCEMENT:

Circular Letter of the Medical Device Authority No. 5 Year 2016: The Medical Device Authority Meeting No. 3/2016 has decided to set the policy for imposition of charges or fees for product classification. The product classification will be charged RM300.00 per application effective on 1st December 2016.

PAYMENT:

All fees shall be paid through bank draft. CASH WILL NOT BE accepted. We will not be responsible for the cash sent or brought to MDA;

The bank draft must be made payable to "KUMPULAN WANG PIHAK BERKUASA PERANTI PERUBATAN" and sent to MDA office;

Information on reference number and Phone No. of the applicant must be written at the back of the bank draft but not in the table section;

Payment must be made within 14 days after date of payment advice issued from MDA.

Complete submission for product classification application will be processed within 14 -21 working days. However, the time frame may take longer if the product needs to be further discussed.

The above requirements will subject to change from time to time.

INQUIRY:

Inquiries can be sent to Medical Device Authority (MDA) at the following address:

          Chief Executive,

          Medical Device Authority (MDA), Ministry of Health Malaysia,

          Level 5, No. 26, Menara Prisma, Precinct 3,

          62675 Putrajaya, MALAYSIA.

          Tel: +603-8892 2400 | Fax : +603-8892 2500          

Or, please contact :

           Tel: +603-8892 2400, Fax: +063-8892 2500

           Email: This e-mail address is being protected from spam bots, you need JavaScript enabled to view it       

           Contact Person: Ms Maryam Nazeera / Ms Nurul Hidayah

Last Updated ( Wednesday, 04 January 2017 )
 
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