This webinar covers China post market surveillance (PMS). NMPA (CFDA) has started to put more emphasis on post market supervision than ever before. Three key areas will be discussed: adverse events (AE), recalls and overseas inspection. Two key regulations were issued in the past year on AEs and overseas inspection.
Watch a 30-second introduction:
Decree No.1 for Medical Device Adverse Event Reporting and Reevaluation issued on August 31st was implemented January 1st, 2019. For the 1st time, NMPA (CFDA) imposed severe penalties for violations. On December 28th, 2018, National Medical Products Administration (NMPA) issued ‘Administrative Regulations of Drug and Medical Device Overseas Inspection’ (NMPA order No. 101 2018) implemented from the date of publication. Provincial NMPA (CFDA) offices will take major responsibility for surveillance whereas overseas inspection responsibility resides at the national NMPA (CFDA) office.
Topics will cover:
What are the current status of AE and recalls?
What are the requirements and penalties for AE reporting?
What should foreign companies do to comply with China new PMS requirements?
What is the best practice for overseas inspection from preparation to on-site inspection to post inspection follow up?
What are the requirements for NMPA (CFDA) recalls?
This webinar covers China post market surveillance (PMS). NMPA (CFDA) has started to put more emphasis on post market supervision than ever before. Three key areas will be discussed: adverse events (AE), recalls and overseas inspection. Two key regulations were issued in the past year on AEs and overseas inspection.
Decree No.1 for Medical Device Adverse Event Reporting and Reevaluation issued on August 31st was implemented January 1st, 2019. For the 1st time, NMPA (CFDA) imposed severe penalties for violations. On December 28th, 2018, National Medical Products Administration (NMPA) issued ‘Administrative Regulations of Drug and Medical Device Overseas Inspection’ (NMPA order No. 101 2018) implemented from the date of publication. Provincial NMPA (CFDA) offices will take major responsibility for surveillance whereas overseas inspection responsibility resides at the national NMPA (CFDA) office.
Topics will cover:
What are the current status of AE and recalls?
What are the requirements and penalties for AE reporting?
What should foreign companies do to comply with China new PMS requirements?
What is the best practice for overseas inspection from preparation to on-site inspection to post inspection follow up?
What are the requirements for NMPA (CFDA) recalls?
China FDA (NMPA) requires local type testing for the market approval of Class II and Class III medical device/IVD products. China local type testing is a mandatory step for registration and must be completed before the initiation of local clinical studies if needed.
Before starting a local type testing in China, you must be ready to answer questions such as:
What tests need to be done in China?
Which testing center should I use?
What Chinese technical standards apply to my products?
When is the best time to plan for the tests?
How to write a Product Technical Requirement (PTR)?
Do certain tests in China need to be repeated?
Do we need type testing for renewal submissions?
Get answers to these questions and more during this informative webinar!
In Spring 2018, China’s State Council unveiled a plan to reshuffle government ministries. Along with the reshuffling plan, the China Food and Drug Administration has now changed its name to the National Medical Product Administration (NMPA). The name change is just the tip of iceberg. The NMPA changes will offer both opportunities and challenges to many foreign companies targeting the Chinese market.
ChinaMed is offering the online webinar to update you in the following areas:
Difference between USFDA and NMPA
Major NMPA Updates in 2018 (Hainan policy, new classification rules, legal agent, registration holder system, overseas clinical data etc.)
Following the 13th Five Year Plan from 2016 to 2020, China FDA (CFDA) is planning to conduct oversea inspection covering all imported high risk imported medical devices. Whether you are selling or planning to sell your medical devices in China, you could receive CFDA oversea inspection notice at some point. So far in 2018, CFDA has published its inspection reports for eight foreign medical devices covering U.S. Europe, Japan, and Australia manufacturers. There are more inspection reports and notice coming out. You could be on the NEXT inspection list! The oversea inspection webinar will include the following contents: 1. Interpretation of the CFDA Medical Device Oversea Inspection Guideline. 2. What are the common observations during the inspection? 2. What are the likely penalties and warnings issued by CFDA? 3. How to prepare for the CFDA oversea inspection?
CFDA clinical requirements for medical device/IVD have been evolving dynamically in the past few years. It is important for foreign manufacturers to understand the China specific clinical requirements, available clinical routes with CFDA registration, and major clinical related regulatory changes.
This webinar will cover the following aspects:
What are the criteria for different clinical routes in China?
How much does it cost you to run clinical trials in China?
When should you decide which clinical route to take in China?
What are the key ingredients for effective clinical trial in China?
China has become the 2nd largest med-tech market in the world. “Innovation in China” policies under President Xi benefits many domestic and foreign manufacturers in China. Chinese government has determined to spend $125 million over the next three years, promising all citizens the access to basic health care by 2020. The market’s prosperous development will enjoy many American med-tech companies. But there are challenges along the road to success: dynamic regulatory changes and CFDA’s increasingly mature and rigorous registration review.
This webinar will interpret the challenges and solutions in the following areas:
Why do you choose China: the unique characteristics of China medical device market
What is new and what you will expect: the changing landscape of med-tech market under key healthcare initiatives
How to navigate your CFDA approval: registration process, China local testing, innovation pathway, clinical requirements
How to sell your products: key factors for successful medical device commercialization in China
IVD related CFDA regulations have gone through significant changes and there are more to come in 2018. The classification rules, regulation category and clinical requirements of CFDA are very different FDA. During this webinar Grace will discuss the key factors that will impact your IVD registration success as well as the IVD development trend in China.
After this 90-minute webinar you will have a practical understanding of the following areas:
Latest key updates of IVD regulations, guidelines, and standards in 2017
Specific IVD classification rules and registration unit division
Significant requirements that you need to compliant for your type testing success
Newest China GCP requirements for your IVD clinical trial and CER
Different registration pathway and according timeline for IVD registration
Complete Registration dossier requirements and best practices
During this session Grace will discuss recent developments in manufacturing regulations including new GMPs, self-inspections, foreign inspections and trends in enforcement. These developments can affect all medical device companies, whether your manufacturing facilities are in China or abroad.
After this 90-minute session you will have a practical understanding of the following compliance issues:
Implementation of the new GMPs, including the procedural rules for inspections, preparation, communicating with investigators, resolving issues, and potential penalties.
Transfer of manufacturing sites and amendment of manufacturing and device licenses.
Policies and rules on contract manufacturing for medical devices.
Handling self-inspections and evaluations of past compliance, including recent examples.
