Purchase Options

This webinar is intended to help you get familiar with medical device laws and regulations in Asian countries: China, Hong Kong, Japan, and Korea.

The medical devices are currently one of the fastest growing industries. The current knowledge and accurate understanding and adequate interpretation of global medical device laws, regulations and regulatory requirements have become increasingly important in our competitive global market. Global regulations of medical devices are rapidly evolving, integrating the regulatory systems of the advanced medical device regulations. To be able to achieve sustainability and to remain sustainable and competitive in Asian medical device markets, it is necessary to get familiar with applicable and relevant laws and regulations governing medical devices, further streamlining the regulatory process. To do so, we should understand the differences in regulatory frameworks (regulatory requirements and compliance) in a sustainable and effective way.

This webinar is intended to help you understand and accurately interpret applicable laws and regulations governing medical devices in China, Hong Kong, Japan and Korea.

This webinar will help you understand and expedite the registration process for your devices in these Asian countries.

Speaker will present laws and regulations governing medical devices in China, Hong Kong, Japan and Korea. It is designed to help medical device industry implement practical, actionable and sustainable strategy for device registration in these countries and further to streamline their business planning and registration process in Asian countries.

Objectives of the Presentation:

• Laws and regulations governing medical devices in China, Hong Kong, Japan and Korea.
• Definitions and classification
• Regulatory framework for medical devices in China, Hong Kong, Japan and Korea
• Regulatory requirements for medical devices including in vitro diagnostic devices in China, Hong Kong, Japan and Korea
• How to identify and address the regulatory requirements
• How to establish and maintain systematic methods to meet the regulatory requirements
• How to streamline the regulatory process
• Instructor’s unique regulatory guide to provide practical, actionable and sustainable solutions in an integrated, through (PASS-IT) manner.

Who can Benefit:

• Regulatory Affairs Managers, Directors and VPs
• Clinical Affairs Managers, Directors and VPs
• Quality Managers, Directors and VPs
• Compliance Managers and Directors
• Sales and Marketing Managers, Directors, and VPs
• Complaint Handling and Risk Management Managers and Directors
• Site Managers, Directors, and Consultants
• Senior and Executive Management
• Compliance Officers and Legal Counsel
• Business Development Managers, Directors, and VPs

Live Session – How it works

• We will send Username and password 24 hours prior to webinar at your email address.
• Webinar presentation handouts will be shared in pdf format, a day before live presentation.
• Use the login details to participate in sessions.
• Clear out your queries through interactive Q&A chat boxes with the speaker.
• We need to know your experience, so please don’t skip to provide us with your overall presentation feedback.
• Get certification of attendance.

Recorded Session – How it works

• Once you purchase a webinar you will receive username and password at your email address.
• Use the login details to view recorded webinars.
• Presentation handouts will also be shared in pdf format.
• Access to the recording is valid only till 6 months starting from the date of purchase.
• Get certification of attendance.

Instructor Profile:

Purchase Options

What is MDSAP and where is it going? Will it eventually touch my business anywhere in the world? MDSAP is creating a playing field among regulatory bodies around the world. That playing field consists of the 6 critical regulatory bodies that are participating in the development of future considerations for an equivalent and reciprocal set of conscript elements of compliance to GMP conditions of operation.

This coupled with the leveraging of qualified registrars to perform such audits solves the question of the logistics in the favor of all regulated manufacturing. Numbers show that a risk-based approach to an audit plan of less than 3% of manufacturing is the dilemma. If this means more acceptances with conformance standards that come closer to the QSR approach then the trade-off is a win-win for regulators and conformance bodies.

Objectives of the Presentation

• An explanation regarding the design and execution of MDSAP
• The status of the program
• What is the anticipated plan for MDSAP on a 2-3-year horizon?
• Why it makes sense to have growth-risk-based QMS to meet QSR requirements for GMP
• What an export program from the US means and how it comes back to GMP controls
• Auditors? Internal, external, independent, and others who qualify this program
• Status as of 2018 in participation, shortages to the program and planning forums
• Interactive Q&A Session

Instructor Profile: