INVITATION TO ‘MEDICAL DEVICE WORKSHOP SERIES’, 3 & 4 JULY 2023
Center for Innovation in Medical Engineering (CIME), Universiti Malaya in collaboration with MdDeV Sdn Bhd is pleased to invite all medical device practitioners who would like to understand medical devices registration requirements based on Malaysia regulatory requirements, online MEDCAST application, re-registration, and change notification for registered medical devices in Malaysia.There will be 2 separate workshops organized and details on both the HRDF claimable programs are listed below:
WORKSHOP 1: COMPLETE GUIDE ON REGISTRATION & RE-REGISTRATION OF MEDICAL DEVICES IN MALAYSIA [7 CPD points]
Speaker: 1. Ir. Dr. Sasikala Devi A/P Thangavelu (Head of Medical Device Lab, Adjunct Professor Cime, Universiti Malaya)
2. Madam Mariammah Krishnasamy, (Principal Assistant Director, Medical Device Registration Section, Medical Device Authority (MDA))
Date: 3 July 2023 (Monday)
Time: 9.00 am – 5.00 pm
Venue: Faculty of Engineering, Universiti Malaya
Special Rate: RM1300/pax or early birds before 20 June 2023 (Tuesday), or group registration consisting minimum of 5 participants.
Registration fees: RM 1500/pax
Workshop Highlights
The training aims to provide a complete guide on the registration and re-registration of medical devices in Malaysia. The training provides a detailed guide on the regulatory and technical documentation requirements for medical device placement in Malaysia. An overall understanding of the requirements of conformity assessment procedures, verification, and full assessment route, documentation requirement for medical device registration, and re-registration. This training also gives guidance on how to use the online systems, Medical Device Centralised Online Application System (MeDC@St)
WORKSHOP 2: COMPLETE SUBMISSION GUIDE ON REGISTRATION & RE-REGISTRATION OF MEDICAL DEVICES IN MALAYSIA [7 CPD points]
Speaker: 1. Ir. Dr. Sasikala Devi A/P Thangavelu (Head of Medical Device Lab, Adjunct Professor Cime, Universiti Malaya)
2. Madam Mariammah Krishnasamy, (Principal Assistant Director, Medical Device Registration Section, Medical Device Authority (MDA))
Date: 4 July 2023 (Tuesday)
Time: 9.00 am – 5.00 pm
Venue: Faculty of Engineering, Universiti Malaya
Special Rate: RM1300/pax or early birds before 20 June 2023 (Tuesday), or group registration consisting minimum of 5 participants.
Registration fees: RM 1500/pax.
Workshop Highlights
The training goal is to provide a complete practical guide on documentation development for the registration of medical devices in Malaysia. Several case studies for Class A, B, C, and D medical device registration documentation will be covered in this hands-on training session. The training details the requirements of conformity assessment procedures, verification, and full assessment route, documentation requirement for medical device registration, and re-registration. The training will assist participants in document preparations for MedCast online application system to register medical devices in Malaysia.
NOTE: For participants who are keen to join both workshops, the registration fees are RM2600/pax or early birds before 20 June 2023 (Tuesday), or group registration consisting minimum of 5 participants.
Normal price: RM 3000/pax only.Please note that the workshops are HRDF claimable, with 7 CPD points available each and certificates available.
For HRDF claimable process, kindly liaise with Ms. Annisaa a week before the workshop at secretariat.cimemd@gmail.com
Please scan the QR Code for registration or click the registration link: