HANDS-ON WORKSHOP – EFFICIENT WAY TO PREPARE FOR MDA DOCUMENTATION SUBMISSIONS (DAY 1: LICENSING)

14 March 2022 – Hands-On Workshop on Efficient Way to Prepare for MDA Documentation Submissions was physically held at the MDA office. The speaker for this workshop was Mr. Muhd Radhuan Bin Abdul Halim as Head of Establishment Licensing, CAB Registration, and Product Classification Branch, Pre-Market Control Division.  Apart from that, Mr. Syahmi Bin Sapit was also the speaker for the workshop. He is a Senior Assistant Director, Licensing Unit Pre-Market Control Division.

 

This workshop provides a face-to-face platform for medical device establishments, medical device industry representatives, conformity assessment bodies, and stakeholders to have an in-depth understanding of the regulatory requirements by the Medical Device Authority (MDA) based on Act 737, Medical Device Regulation 2012, Medical Device Regulation 2019 and Medical Device (Exemption) Order 2016. This workshop is beneficial to establishments, the medical device industry, especially to new start-up companies.

 

The objective of this workshop is to provide guidance on how to comply with Act 737, Medical Device Regulation 2012, Medical Device Regulation 2019, and Medical Device (Exemption) Order 2016. This workshop is also to provide hands-on experience in the submission of application/notification and to share information of regulatory requirements on medical device regulations. Furthermore, it is to ensure the compliance of the regulatory requirement to the Act and regulations under it and to improve the documentation submission. Moreover, this Workshop focuses on Licensing on Day 1, Registration on Day 2, Post Market on Day 3, and Industry Facilitation on Day 4. On the first day, a total of 17 participants attended the workshop.