Malesia

The information on this page is valid and current as of June 2017. The legislative and regulatory provisions are subject to changes and updates by the Regulatory Authorities of the State to which they refer. Considering the above, the writer declines all responsibility regarding any non-actuality and/or inaccuracy of the information received concurrently with or following the publication of this page Disclaimer


Regulatory Authority:
Medical Device Authority (MDA)

Classification:
A, B, C, D

Quality system:
ISO 13485

Procedure:
Medical Devices are subject to registration.
Manufacturers with no local presence in Malaysia must appoint a Local Authorized Representative responsible for the documentation compliance and submission to the MDA.
In case of MDA favourable outcome, an acceptance notification will be issued.

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Applicant:
Manufacturer or the Local Authorized Representative

Timeframe and fees:
About 1- 9 months

Validity:
Registration Certificate validity: 5 years

Labeling and documentation language:
Medical Device Instructions for use and label can be provided in English.

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