MY | GDPMD Clauses Interpretation

Language : English

Please choose a date from the options below					Please choose a date from the options below	Location	Price
On demand Klang Valley	Klang Valley		Book

Malaysia imposes the Medical Device Regulation 2012 for medical devices industry and thus the related organisations are required to set up and comply with the regulation. In this training, the participants will be guided with the explanation and discussion on each requirement of GDPMD so that they are able to understand and implement the regulation effectively. This training is to guide the participants with the knowledge and skill to establish the GDPMD regulatory system in their organization.

FOR WHOM:

This course is designed for individuals in the medical device local authorized representative, distributor and importer who are involved in the development and maintenance of a quality management system based on GDPMD. No prerequisites are necessary for this course.

How you will benefit:

Champion GDPMD benefits
Fulfil GDPMD standard / regulatory requirements.
Give participants an awareness of GDPMD and its alignment to respective Quality System Regulation
Assist participants in the relationship between QMS and registration
Identify what GDPMD and also what is regulatory expectation

Agenda

Session 1: Introduction of Medical Device and GDPMD (Good Distribution Practices for Medical Device)

As a start, participants will be presented with the fundamentals, brief concepts, purposes, set up, certification and audit flow as well as the application of the regulation in Medical Device industry nationally and internationally.

Session 2: GDPMD: Part 1 and 2

Participants will be guided with the explanation of the requirements in the Part 1 (Preliminary) and Part 2 (Regulatory Compliance System).

Session 3: GDPMD: Part 3 and 4

Participants will be guided with the explanation of the requirements in the Part 3 (Establishment Responsibilities) and Part 4 (Resource Management).

Session 4: GDPMD: Part 5 and Part 6

Participants will be guided with the explanation of the requirements in the Part 5 (Supply Chain and Device Specific) and Part 6 (Surveillance and Vigilance).
Audit experience sharing related to GDPMD

Guidance Document related to GDPMD

Pre-Market Medical Device Registration
Establishment License
Advertisement
Post Market Surveillance and Vigilance
Medical Device Exemption