World Conference Calendar

33622 Conferences

Medical Device Registration and Approval Process for the Pacific Rim 2017

Added by globalcompliancepanel on 2017-09-06

Conference Dates:

Start Date Start Date: 2017-11-06
Last Date Last Day: 2017-11-07
Deadline for abstracts/proposals Deadline for abstracts/proposals: 2017-11-05

Conference Contact Info:

Contact Person Contact Person: Event Manager
Email Email: john.robinson@globalcompliancepanel.com
Address Address: Singapore, Singapore, Singapore
Phone Tel: 800-447-9407
Phone Fax: 302-288-6884

Conference Description:

Course "Medical Device Registration and Approval Process for the Pacific Rim (including India, Japan, China, Singapore, Australia, Taiwan, Hong Kong, and other locations)" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Overview:

Classification systems differ from that of the United States or European Union in select countries
Medical devices are classified depending on their risk level
Medical devices must also comply with additional country standards and these standards define industry-wide safety and performance requirements
Regulatory registration process is defined for China, Hong Kong, India, Japan, South Korea, Taiwan, Singapore and Australia
The regulatory process from product design to market entry for a new medical device or IVD is oftentimes complicated and unclear.
In Asia Pacific, it can become difficult to make a clear distinction between your regulatory strategy and business strategy.
And Much More...

Why should you attend:

Learn and understand the entire Registration and Approval Process
Identify and understand the changes to Medical Device Registration Process in select countries
Streamline the medical device registration process so that you can obtain approval for your product in the most cost-effective and timely manner
Learn how to access new markets and obtain medical device approval in all the countries listed
Complete your registration in order to obtain medical device approval as efficiently as possible while realizing that some markets/countries will be more challenging
Navigate the regulatory system, achieve product registration, and access the medical market
In a group setting, review and discuss pain points, challenges and workable regulatory and compliance solutions.
Participants will discuss their own device registration and approval process relative to their work-related responsibilities and handling submissions

Areas Covered in the Session:

Which regulatory bodies are responsible for medical device registration in each country?
Are medical devices required to be registered before they can be sold?
What are the different regulatory classifications for medical devices?
What are the different application categories for medical device registration?
What does the registration pathway look like for each regulatory classification?
What are the document requirements for notification for the various classes of medical devices?
What are other requirements that are necessary for approval in addition to the device application?
Is local testing (type testing/sample testing) required for registration?
When are clinical studies required for registration?
Is approval in the Country of Origin required for registration?

Who Will Benefit:

This seminar will provide an overview and in-depth snapshot of the medical device registration and approval process for Asia Pacific and with the corresponding regulatory authorities. Employees who will benefit include all levels of management and departmental representatives from key functional areas and those who desire a better understanding or a "refresh" overview of the medical device registration process, including:
Clinical Research Associates
Clinical Project Managers
Regulatory Affairs Professionals
Clinical Investigators and Clinical Research
Regulatory Affairs Management
Regulatory Affairs Specialists
Regulatory Project Leads/SME's
Auditors
Compliance Specialists
Clinical Affairs
Quality Assurance
Consultants
Distributors

Agenda:
Day 1 Schedule

Lecture 1: Medical Device Registration and Approval Process
Introductions and Background
China, Hong Kong, India, Japan, South Korea, Taiwan, Singapore and Australia and overview of the pre and post-registration and approval process
What is the classification scheme for medical devices?
What are the registration procedures?
How are devices classified?
How do regulatory requirements differ for domestic vs. foreign manufacturers?
How long does it take to register devices?
New Registration Pathways for Manufacturers
Revised medical device registration and approval requirements in select countries
Quality management systems (QMS) are streamlined
QMS inspections with Marketing Authorization Holders and Manufacturers


Read More: http://www.globalcompliancepanel.com/con trol/globalseminars/~product_id=900992SE MINAR?worldconferencecalendar-November-2 017-SEO
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