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EXEMPTION FROM REGISTRATION OF MEDICAL DEVICES PDF Print E-mail

EXEMPTION FROM REGISTRATION OF MEDICAL DEVICES

Circular Letter of the Medical Device Authority No.3 Year 2014: Exemption of Medical Device from Registration Requirements has provided an administrative exemption from registration medical device for:

1.    The purpose of demonstration for marketing

2.    The purpose of education

3.    The purpose of clinical research or performance evaluation of medical device

4.    A Custom-Made Medical Device; or

5.    A Special Access Medical Device

This exemption is given subject to Medical Device Authority (MDA) being notified before MDA Issues a letter of No Objection to permit the importation and/or to be placed in the market.

To ensure adherence to the Medical Device Act 2012 (Act 737), The Minister of Health has considered an exemption for medical device for the above purposes through The Medical Device (Exemption) Order 2016 which has been gazetted on 18th April 2016. The Minister exempts from section 5 of the Act for medical device if it is fit with the above purposes and a person who imports or manufactures the above medical device is exempted from the requirement of an establishment license under subsection 15(1) of the Act.

Hence, the Circular Letter of MDA No.3 Year 2014 will no longer effective and from 18 April 2016 kindly submit the revised notification form as below:

1.    Notification of Medical Device for Demonstration                                                                                            PDF  | WORD

2.    Notification to Import Or Supply Medical Devices For Clinical Investigational Use                                                   PDF  | WORD

3.    Notification To Import Medical Devices For Clinical Use And Research Suportive Use                                           PDF  | WORD

        4     Notification of Change On Clinical Trial For Medical Devices Use                                                                            PDF  | WORD

        5     Investigational Device (IDE) Progress Report                                                                                                           PDF  | WORD

        6     Serious Adverse Events (SAE)                                                                                                                                 PDF   | WORD

        7     Notification For Export/Disposal of Devices Upon Completion/Termination of Clinical Investigation /Drug Study   PDF   | WORD  

8.     Notification of Unregistered Medical Device for Custom Made                                                                   PDF   | WORD

9.     Notification of Unregistered Medical Device for Special Access                                                                   PDF   | WORD

For the purpose of submission the application please email to

1.    This e-mail address is being protected from spam bots, you need JavaScript enabled to view it for notification to Import and/or Supply Medical Device for Clinical Investigation Use

 

2.    This e-mail address is being protected from spam bots, you need JavaScript enabled to view it for Notification of Medical Device for Demonstration, Notification of Unregistered Medical Device for Custom Made and Notification of Unregistered Medical Device for Special Access.

 

 

Last Updated ( Friday, 26 May 2017 )
 
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