Medical Device Authority (MDA) has published a draft guidance document ‘WEARABLE MEDICAL DEVICE” for public comment.

This guidance document is intended to provide regulatory requirements for wearable medical device and examples of wearable products.

We would like to invite the industry and stakeholders to provide feedback on this draft guidance document. The public comment period for this draft guidance document is from 22 August to 8 September 2023. Please submit your feedback using the attached public comment form to anissuhaila@mda.gov.my before 8 September 2023.

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;

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

d) Medical Device (Advertising) Regulations 2019.

To download guidance document, please download Attachment 1. To download feedback form, please download Attachment 2.

 

Updated: 21 August 2023