Seminar on Medical Device Registration and Approval Process for the Pacific Rim (including India, Japan, China, Singapore, Australia, Taiwan, Hong Kong, and other locations) training seminars presented by Global Compliance Panel register now on FindaSeminar.com

findaseminar logo balls FindaSeminar.com
event search registration and marketing services since 2002
Advanced Search
 
 

** NOTE: All April seminars are live Virtual or Online click to view events.

Seminar on Medical Device Registration and Approval Process for the Pacific Rim (including India, Japan, China, Singapore, Australia, Taiwan, Hong Kong, and other locations)  

 Email information about this seminar Seminar on Medical Device Registration and Approval Process for the Pacific Rim (including India, Japan, China, Singapore, Australia, Taiwan, Hong Kong, and other locations) by Global Compliance Panel to yourself your manager or associates Email this event... View and register for other training seminars like Seminar on Medical Device Registration and Approval Process for the Pacific Rim (including India, Japan, China, Singapore, Australia, Taiwan, Hong Kong, and other locations) by Global Compliance Panel on FindaSeminar.com Find similar training.. Find and register for other training seminars by Global Compliance Panel on FindaSeminar.com Other seminars from Global Compliance Panel

By:

Global Compliance Panel   

For:

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

Cost:   

see Registration info for seminar cost, group discount etc.

Seminar Summary:

 (see full course description)

 

 Seminar / Training class dates & locations

 

No seminar dates for this event are currently scheduled.  Please use the seminars search box above or choose one of the following additional training search options to find similar training.

medical+device+regulations+USA+china+Japan+marketing+classifications training seminars workshops conferences online training

Providers course catalog

Find seminars by state

Find seminars by city

Request on site training

Use Advanced Search

NEW  Don't miss training you want to attend

Receive a personal Training Alert when training you want to attend comes to your area. Create a personal Training Alert now  it's Free and only takes a minute!


 

 

 

share this page 

print the agenda print agenda for the Seminar on Medical Device Registration and Approval Process for the Pacific Rim (including India, Japan, China, Singapore, Australia, Taiwan, Hong Kong, and other locations) seminar

 

 

Training Course Syllabus:


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?


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
Key Guidelines and Resources
Will our clinical studies and testing conducted outside the countries be accepted?
Lecture 2: Exercise and Recap of Day 1

Interactive Discussions
Review of Regulatory Documents
Day 2 Schedule

Lecture 1: Medical Device Registration and Approval Process

Medical Device Registration and Approval Process and Recap from Day 1
China, Hong Kong, India, Japan, South Korea, Taiwan, Singapore and Australia and overview of the pre-registration and post-registration and approval process
Documentation required for review and approval
Registration and country codes and other requirements
In-Country Representative/Marketing Authorization Holders/Authorized Representatives
QMS and other requirements
Documentation and Additional Materials for Registration and Approval
Consultation sessions with Regulatory Authorities, how to maximize foreign clinical data, and how to expedite product registration
Trends and lessons learned with recent and current registrations
New medical device regulations and approval requirements are released on a regular basis sometimes and companies must keep track and current
Responding to inquiries and questions from the Regulatory Authorities/Agencies
Regulatory inspection process
Lecture 2: Exercise and Recap of Day 2

Interactive Discussions
Review of Regulatory Documents
Lecture 3: Debrief/Adjourn

Recap of topics and key discussion points and take away message
FAQs and latest trends

speaker:
David R. Dills
Global Regulatory Affairs & Compliance Consultant

Seminar Summary:

 (see full course description)

print this agenda print agenda for the Seminar on Medical Device Registration and Approval Process for the Pacific Rim (including India, Japan, China, Singapore, Australia, Taiwan, Hong Kong, and other locations) training seminar

 view dates and locations for this seminar

 

 

 

Custom Search