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

26 – 29 SEPTEMBER 2022: Medical Device Authority (MDA) has organized a four-day face-to-face workshop titled "Hands-On Workshop - Efficient Way to Prepare for MDA Documentation Submissions" that is mindfully curated to assist the industry in effectively preparing documents required by the authority for better submissions and fewer errors. This workshop also gives guidance on how to use the online systems created by MDA such as Medical Device Centralized Online Application System (MeDC@St) and Medical Device Centralized Reporting System (MeDCReSt). The modules offered are Module 1: Licensing on the 26th, Module 2: Registration on the 27th, Module 3: Post-Market on the 28th, and Module 4: Industry Facilitation on the 29th at Meranti Room, MDA, Cyberjaya.

The objectives of this workshop are to guide how to comply with Act 737, Medical Device Regulation 2012, Medical Device Regulation 2019, and Medical Device (Exemption) Order 2016 while also providing hands-on experience in the submission of applications/notifications and ensuring compliance to the regulatory requirement provided in the Act and regulations under it.

The Module 1: Licensing workshop which commenced on the 26th of September 2022 is aimed to provide guidance and step-by-step assistance for medical device establishments to apply for establishment licenses, renewal of establishment licenses, identify major and minor amendments on establishment licenses, surrender establishments and submit a change of ownership of medical device on the MeDC@St online application system. Module 1: Licensing workshop was joined by 18 participants consisting of manufacturers, authorized, importers, distributors, and medical device industry representatives.

The Module 2: Registration workshop which commenced on the 27th of September 2022 is aimed to provide guidance and step-by-step assistance for medical device representatives to classify medical and non-medical devices, register combination products, identify MD classes, grouping and registration process, re-register medical devices and submitting change notification on the MeDC@St online application system. A total of 45 individuals from the medical device industry consisting of medical device representatives and designated persons participated in Module 2: Registration workshop.

Module 3: Post-Market workshop commenced on the 28th of September 2022 is aimed to provide guidance and step-by-step assistance for medical device establishments to make a complaint, mandatory problem reporting (MPR), field corrective action (FCA), and recall relating to MD on the new MeDCreSt online reporting system. This module also offers guidance on how to apply for MD advertisements and identify the current labelling requirements of MD. Module 3: Post Market workshop was joined by 36 participants consisting of manufacturers, authorized representatives, and medical device industry representatives.

The Module 4: Industry Facilitation workshop that commenced on the 29th of September 2022 is aimed to provide guidance and step-by-step assistance for medical device representatives who wish to obtain Certificate Free Sale (CFS) and Manufacturing Certificate (MC), only Export MD, identify MD that can be allowed for Special Access, import Custom-Made MD, use MD for Demonstration for Marketing, Education, or Clinical Research Use. A total of 10 individuals from the medical device industry consisting of medical device representatives and designated persons participated in Module 4: Industry Facilitation workshop.

Author: Alya Jazmina, Assistant Director (DASAR)