HANDS-ON WORKSHOP – EFFICIENT WAY TO PREPARE FOR MDA DOCUMENTATION SUBMISSIONS (DAY 2: REGISTRATION)

15 March 2022 – Hands-On Workshop on Efficient Way to Prepare for MDA Documentation Submissions was physically held at the MDA office. This workshop is for medical device representatives who wish to assess and register the products. Pn. Nur Athirah Bt Hashim, Pn. Nurul Hidayah Bt A. Azmi, Pn. Noormaslinda Bt Abd Salam, En. Muhammad Hazman Bin Mohd Zaini, Pn. Norfazila Bt Zulkifli, and Pn. Mariammah A/P Krishnasamy are the speakers for this workshop from the Pre-Market Control Division, Medical Device Authority (MDA).

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 second day, a total of 28 participants attended the workshop.