HANDS-ON WORKSHOP - EFFICIENT WAY TO PREPARE FOR MDA DOCUMENTATION SUBMISSIONS

27 JULY 2022: Medical Device Authority (MDA) has organised a two-day workshop titled "Hands-On Workshop - Efficient Way to Prepare for MDA Documentation Submissions" on the 27th and 28th of July 2022 at Meranti Room, MDA, Cyberjaya.

The objective of this workshop is to guide how to comply with Act 737, Medical Device Regulation 2012, Medical Device Regulation 2019, and Medical Device (Exemption) Order 2016. Other than that, this workshop also provides hands-on experience in submission of application/notification and sharing information on regulatory requirements on medical device regulations. Besides that, this is to ensure the compliance of the regulatory requirement to the Act and regulations under it and to improve the documentation submission to MDA.

The Module 1: Post-Market workshop which commenced on the 27th of July 2022 is aimed to provide guidance and step-by-step assistance for medical device establishments to do complaint handling, mandatory problem reporting, field corrective action, recall, labelling, and understanding code of advertisement and apply for advertisement. Module 1: Post-Market workshop was joined by 55 participants consisting of manufacturers, authorized, importers, distributors and medical device industry representatives.

The Module 2: Industry Facilitation workshop commenced on the 28th of July 2022 is aimed to provide guidance and step-by-step assistance for medical device representatives to apply for Certificate Free Sales (CFS), Manufacturing Certificate (MC), Notification for Export Only, Notification for Special Access Medical Device, Custom-Made Medical Device, Clinical Research Use, Demonstration for Marketing and Education. A total of 16 individuals from the medical device industry consisting of medical device representatives and designated persons participated in Module 2: Industry Facilitation workshop.

Author: Alya Jazmina, MDA Core