This training program is intended as introductory course to provide participants to companies developing and producing medical devices is to be updated on the regulatory requirements and implement them in the process. In order to market medical devices, compliance to applicable laws and regulations is important. Manufacturers are required not only to comply with regulations of their own country but also regulation of countries in which their products are marketed. This constitutes a great problem for manufacturers, especially for companies selling their products in several countries. Competent authorities have begun to realize the problem and collaborate to harmonize the regulations.
This 2 days seminar provides an opportunity to participants to have an insight of the Regulatory Systems and procedures to market Medical devices in Japan, US and international markets. This topic addresses the integration of ISO 13485:2003, Japanese GMP for Medical Devices and Quality System Regulations (21 CFR Part 820)
Feedback from the attendances as below:
"Trainer is professional and has explained the more details to more clearly "
Khun Suparat Phuntong
(Cardinal Health 222 (Thailand) Ltd.)
"Trainer had adequate knowledge"
Khun Panuwat O-Thong
( Phuket OEM Co.,Ltd)