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Malaysia’s MDA- Draft Medical Device Labeling Guidance

The Medical Device Authority (MDA) of Malaysia is seeking feedback on draft regulations for medical device labeling. The MDA's fifth edition of the guidance features changes to guidelines for general contents of labeling and other sections.

This Guidance Document was prepared to help the industry and healthcare professionals in their quest to comply with the Medical Device Act (Act 737) and the regulations under it. This document is intended to provide guidance to manufacturers and authorized representatives on the content of medical device labeling.

This Guidance Document shall be read in conjunction with the current laws and regulations used in Malaysia, which include but not limited to the following-

a) Medical Device Act 2012 (Act 737);

b) Medical Device Regulations 2012; and

c) Medical Device (Duties and Obligations of Establishments) Regulations 2019

Promotional materials and product brochures are excluded from the document.

The draft version of the MDA standard allows certain information to be provided in the form of an insert, and the ISO standard addresses the application of risk management to medical devices. In its proposal, MDA outlines information such as the device's instructions for use, any postmarket servicing requirements, and any undesirable side effects, limitations or warnings.

MDA is accepting feedback until 28 April.

Click this LINK to know more detailed information on the guidance.


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