REGULATORY TRAINING - POST MARKET REQUIREMENTS
OVERVIEW
MDA Regulatory Training on Post Market requirements is a 1-day course that helps you to have a better view and understanding on the requirements of post markets duties and obligations as stipulated in the Medical Device Act (Act 737) and Medical Device Regulation Act 2012 to enable the effective implementation of post-market systems in the medical device industry.
Our speaker will share information on the requirements of post-market surveillance and vigilance and provides expert advice for manufacturers, medical device professionals, and interested individuals throughout the course.
In this training, you will learn the concept on collecting and analyzing the post market data, identifying the reportable incident and reporting steps, and applying the root cause analysis to determine the corrective and preventive actions including implementation of field corrective actions (FCA) and conducting a recall as well as how to integrate those elements in the quality management system (QMS).
OBJECTIVE
To provide explanations and disclosures regarding to post-market responsibilities based on Act 737 and the Medical Devices (Duties and Obligations of Establishments) Regulations 2019 to ensure the implementation is according to MDA's expectations and complies with the outlined legal requirements.
TARGET AUDIENCE
- Establishment (especially manufacturer and AR)
- Medical device professionals involved in maintenance of medical device, post market surveillance, complaint handling, incident reporting, and regulatory compliance
- Regulatory affairs managers
- Quality managers
- Clinical/Medical professionals
- Interested individuals
TENTATIVE
REGISTRATION & TRAINING FEE
- The closing date for registration is 22 November 2023 (Wednesday).
- Training fee per participant: RM 1000
- To register, please click HERE
- Upon acceptance of the registration, an invoice (for payment purposes) together with details of the payment method will be issued accordingly
- Registration of participants will be on a first-come-first-served basis.
- Upon payment confirmation, MDA will provide the workshop ticket through email.
- Once paid, the registration fee is non-refundable.
CONTACT
For enquiries, please contact cc or 03-8230 0307 (Pn. Halimah)
Updated: 27 October 2023
