DUBLIN--(BUSINESS WIRE)--Research and Markets has announced the addition of the "Medical Device Registration and Approval Process for the Pacific Rim (including India, Japan, China, Singapore, Australia, Taiwan, Hong Kong, and other locations)" conference to their offering.
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?
For more information about this conference visit http://www.researchandmarkets.com/research/3vw5fh/medical_device