Informa Life Sciences

This is ideal for newcomers to the industry or for those who are looking for a refresher in Medical Device regulations.

• Regulatory Affairs Professionals
• Quality Assurance Professionals
• Sales & Marketing Managers
• Product Development Managers
• Technical Managers

• Statutory basis for FDA regulation of medical devices in the US, including relevant regulations

• FDA organisational structure

• Risk-based classification system for medical devices plus general and specific controls

• Investigational devices

• Types of submissions

• Pathways to market, including premarket notification 510(k) and premarket approval (PMA)

• Additional requirements for marketing, including registration and listing, labelling, quality system regulation (QSR), and medical device reporting (MDR)

• Working with the Center for Devices and Radiological Health (CDRH)

Course Leader: Trevor Lewis, Principal Consultant, Medical Device Consultancy, UK

An increasing number of medical device manufacturers are manufacturing and selling their products in the Asian market, including Japan.

In addition, Asian governments are developing new or more rigorous regulatory regimes to raise the quality of medical devices in their countries to international standards, in particular the implementation of the new Pharmaceutical Affairs Law in April 2005, and the new Market Authorization Holder system have changed the Japanese regulatory market.

This workshop highlights recent regulatory developments for medical devices in Japan and discusses changes in procedures such as:

• New requirements for foreign manufacturers

• Use of the MAH including subsidiaries

• New QMS requirements

• New PMS requirements