Address
Medsociate Sdn Bhd
19-2, Jalan Vervea 12, Vervea,
Bandar Cassia, 14110
Penang, Malaysia.
Contact
Email:admin@medsociate.com
Hotline: +6010 4040 662
Date: 21,22 and 23 September 2022
Time: 9.00am – 5.30pm (Registration starts at 8.30am)
Venue: Pullman Kuala Lumpur Bangsar Hotel,
No 1, Jalan Pantai Baharu, Jaya Tower 3, 59200 Kuala Lumpur
Mode of Training: In-person face-to-face training.
Delivery of Training: The training workshop shall be delivered in English.
Methodology
• Lecture
• Breakout Group Discussion
• Case study
• Quiz
• Pre-test and Post-test
Introduction
The EU Medical Device Regulation (MDR) 2017/745 was published on 5th May 2017,and it has replaced the EU Medical Device Directive (MDD 93/42/EEC) and the EU Active Implantable Medical Device Directive (AIMDD 90/385/EEC). It came into force on the 25th May 2017, and all the related and relevant manufacturers have three years transition period to comply with the EU MDR. However, the European Parliament has adopted and supported the European Commission’s proposal to postpone the effective compliance and application of the EU MDR to 26th May 2021 due to the Covid-19 outbreak.
The 175-page document outlined regulatory requirements to the economic operators (a manufacturer, an authorized representative, an importer and/or a distributor) as well as the notified bodies. The EU MDR also outlined the Rules (with added Rules compared to the previous EU Medical Device Directive) for medical device classification purposes. The EU MDR compliance is important and mandatory for all existing economic operators that involved in marketing medical devices in the EU market as well as all economic operators who wish to expand their medical device distribution into the EU market.
Part 1: Beginner Level
Course Outline
Course Objectives
This course aims to give participants a brief introduction regarding the EU Medical Device Regulation and the course content outlined is to provide participants with:
Course Benefits
Upon completion of this training, participants will: –
Part 2: Intermediate Level
Course Outline
Course Objectives
This course aims to give participants in-depth knowledge regarding the EU Medical Device Regulation and the course content outlined is to provide participants with information on:
Course Benefits
Upon completion of this training, participants will have the knowledge on: –
Trainer’s Profile
Mr Kenny Chong has been involved in the Medical Device Industry for the past 14 years, working with Straits Orthopaedics Sdn Bhd (a contract manufacturer for Smith & Nephew), Symmetry Medical Malaysia Sdn Bhd (Tecomet), Neville-Clarke as well as BSI Services. In this time, his experience throughout the entire product lifecycle and all 3 medical device regulatory stages has enabled him to gain qualification on all medical device technology scopes.
He is a trained CQI & IRCA Lead Auditor of ISO 9001:2015, ISO 14001:2015, OHSAS 18001:2007 as well as ISO13485:2016. He has also attended and passed training on Conformity Assessment Procedures on Quality Management System & Post Market Surveillance by the Medical Device Authority, Malaysia. He holds a Master of Science in Biotechnology and Bachelor of Science (Honours) in General Biology from the University of Science, Malaysia (USM).
Certificate
Expected Result for Target Audience
The Workshop on EU MDR will help Malaysian SME staff who handle and are actively involved in EU MDR compliance planning and execution to better understand and correctly demonstrate/improve compliance with the requirements of EU MDR 2017/745.
Registration:
Multiple applications may be submitted by companies during the registration period. However, kindly be informed that all applications will be subject to review and screening by MATRADE. Successful applications by companies will be communicated directly by Medsociate Sdn. Bhd. by 26 August 2022.
Workshop Background:
The ASEAN Regional Integration Support by the European Union (ARISE) Plus Malaysia supports inclusive and sustainable trade growth and poverty reduction in Malaysia while contributing to economic integration in the ASEAN region. This trade-related technical assistance project is being implemented by the International Trade Centre (ITC) in partnership with the Ministry of International Trade and Industry (MITI). The Department of Standards Malaysia, together with MATRADE are the country partner organisations overseeing the implementation of this workshop under the ARISE Plus Malaysia project.
Programme Overseers:
Programme Managed by:
Medsociate Sdn Bhd in collaboration with the Association of Malaysian Medical Industries (AMMI)
Email: admin@medsociate.com
Hotline: +6010 4040 662