Regulatory Open Forum

Having been in medtech for 20+ years between U.S. and China, I have seen frustration and headaches with our members associated with the CFDA registration at the recent RAPS meeting in San Jose. To help alleviate the frustration experienced with medical device CFDA registration, I have started this chain of discussion and promise to get back to you with your solution.

Some of the frustration could be avoided if the right path has been taken.  I attended the 3 full day RAPS CFDA version in China and saw more changes coming. Since 2015, more than 100 regulations have passed from the central government mandates to CFDA requirements resulting in the biggest shakeup since 2000. The changes impact not only pre-market submission but also registration process evaluation, distribution management, promotion and post market monitoring. Please free to post your questions.

Hi,

I'm RAS at Tijuana Mexico, interested to know which are the main regulation changes/newly created for products to be commercialized in China, when these items are currently being marketed worldwide (their FDA approvals and CE mark already in place). How the new regulations affect the activities performed at our manufacturing sites?

Thank you in advance.

Having been in medtech for 20+ years between U.S. and China, I have seen frustration and headaches with our members associated with the CFDA registration at the recent RAPS meeting in San Jose. To help alleviate the frustration experienced with medical device CFDA registration, I have started this chain of discussion and promise to get back to you with your solution.

Some of the frustration could be avoided if the right path has been taken.  I attended the 3 full day RAPS CFDA version in China and saw more changes coming. Since 2015, more than 100 regulations have passed from the central government mandates to CFDA requirements resulting in the biggest shakeup since 2000. The changes impact not only pre-market submission but also registration process evaluation, distribution management, promotion and post market monitoring. Please free to post your questions.

Having been in medtech for 20+ years between U.S. and China, I have seen frustration and headaches with our members associated with the CFDA registration at the recent RAPS meeting in San Jose. To help alleviate the frustration experienced with medical device CFDA registration, I have started this chain of discussion and promise to get back to you with your solution.

Some of the frustration could be avoided if the right path has been taken.  I attended the 3 full day RAPS CFDA version in China and saw more changes coming. Since 2015, more than 100 regulations have passed from the central government mandates to CFDA requirements resulting in the biggest shakeup since 2000. The changes impact not only pre-market submission but also registration process evaluation, distribution management, promotion and post market monitoring. Please free to post your questions.

Hi Grace,

In my experience with CFDA, there are few problems I encounter and think the bureau need to improve: 

1. The interpretation of regulation / registration requirements does not aligned between local, provincial and central CFDA, creating huge gaps which involved a lot of time and cost to get product registered.
2. Lack of manpower to review registration dossier & manufacturing license application & audit, which further increase the lead time of product registration.
3. Innovative product registration path can be enhanced as it promised fast track product registration. However, lead time incurred are almost the same as ordinary route and more time are required to get all the KOL sit in to discuss device classification, safety and efficacy.

Above are my thoughts based on my experience. 

Thank you.

Having been in medtech for 20+ years between U.S. and China, I have seen frustration and headaches with our members associated with the CFDA registration at the recent RAPS meeting in San Jose. To help alleviate the frustration experienced with medical device CFDA registration, I have started this chain of discussion and promise to get back to you with your solution.

Some of the frustration could be avoided if the right path has been taken.  I attended the 3 full day RAPS CFDA version in China and saw more changes coming. Since 2015, more than 100 regulations have passed from the central government mandates to CFDA requirements resulting in the biggest shakeup since 2000. The changes impact not only pre-market submission but also registration process evaluation, distribution management, promotion and post market monitoring. Please free to post your questions.

Winston

1. Provincial and Local CFDA are very different governing bodies with different regulating domains.  National CFDA located in Beijing governs all imported devices Class I, II and III as well as domestic Class III.  The  regulation / registration requirements do have differences. Pre-planning with the end goal of your business strategies is a critical step to reduce the gaps and save your time and cost to get product registered.  Things will improve in the future with more detailed regulations down the road. It is still a little like the wild west in the U.S. old days. 
2. It looks like you are experiencing challenges with your provincial level license application & audit.  Indeed to set up a brand new GMP facilities do take time in China but varies depending on which province.  But again depending on your business strategy, you could have transition period to shorten the time and pick sites at provinces where they are more efficient. 
3. The qualification for the innovative product registration path could take some time. I assume that you are talking about the invention IP is granted by China PTO type.  If so, it does save time as you do not need to wait in line in your testing or review.  Plus, you get designated person to work with you.  This is especially valuable for high risk devices.  

Hi Grace,

In my experience with CFDA, there are few problems I encounter and think the bureau need to improve: 

1. The interpretation of regulation / registration requirements does not aligned between local, provincial and central CFDA, creating huge gaps which involved a lot of time and cost to get product registered.
2. Lack of manpower to review registration dossier & manufacturing license application & audit, which further increase the lead time of product registration.
3. Innovative product registration path can be enhanced as it promised fast track product registration. However, lead time incurred are almost the same as ordinary route and more time are required to get all the KOL sit in to discuss device classification, safety and efficacy.

Above are my thoughts based on my experience. 

Thank you.

Having been in medtech for 20+ years between U.S. and China, I have seen frustration and headaches with our members associated with the CFDA registration at the recent RAPS meeting in San Jose. To help alleviate the frustration experienced with medical device CFDA registration, I have started this chain of discussion and promise to get back to you with your solution.

Some of the frustration could be avoided if the right path has been taken.  I attended the 3 full day RAPS CFDA version in China and saw more changes coming. Since 2015, more than 100 regulations have passed from the central government mandates to CFDA requirements resulting in the biggest shakeup since 2000. The changes impact not only pre-market submission but also registration process evaluation, distribution management, promotion and post market monitoring. Please free to post your questions.

Hello,

I'm interested to know which are the current QMS requirements for manufacturers of products marketed in China.

Our manufacturing site builds finished devices (implantable, disposable, class II & III) and some of them are already marketed in China (the registration process is handled by our Business Units located mostly in the USA). Up to now, we have not been audited or visited by Chinese government. So, with the recent volume of regulatory changes in China, which specific requirements may affect our daily activities? under which scenarios an audit may be required in order to register and market our products?

Note: Yesterday our Business Unit representative communicated about this: "China Draft Guideline: Guidelines on Quality Control and Finished Products Release for Medical Device Manufacturing Enterprises"

Does anyone has comments about it?  I've not seen the contect yet.

Thank you in advance.

Winston

1. Provincial and Local CFDA are very different governing bodies with different regulating domains.  National CFDA located in Beijing governs all imported devices Class I, II and III as well as domestic Class III.  The  regulation / registration requirements do have differences. Pre-planning with the end goal of your business strategies is a critical step to reduce the gaps and save your time and cost to get product registered.  Things will improve in the future with more detailed regulations down the road. It is still a little like the wild west in the U.S. old days. 
2. It looks like you are experiencing challenges with your provincial level license application & audit.  Indeed to set up a brand new GMP facilities do take time in China but varies depending on which province.  But again depending on your business strategy, you could have transition period to shorten the time and pick sites at provinces where they are more efficient. 
3. The qualification for the innovative product registration path could take some time. I assume that you are talking about the invention IP is granted by China PTO type.  If so, it does save time as you do not need to wait in line in your testing or review.  Plus, you get designated person to work with you.  This is especially valuable for high risk devices.  

Hi Grace,

In my experience with CFDA, there are few problems I encounter and think the bureau need to improve: 

1. The interpretation of regulation / registration requirements does not aligned between local, provincial and central CFDA, creating huge gaps which involved a lot of time and cost to get product registered.
2. Lack of manpower to review registration dossier & manufacturing license application & audit, which further increase the lead time of product registration.
3. Innovative product registration path can be enhanced as it promised fast track product registration. However, lead time incurred are almost the same as ordinary route and more time are required to get all the KOL sit in to discuss device classification, safety and efficacy.

Above are my thoughts based on my experience. 

Thank you.

Having been in medtech for 20+ years between U.S. and China, I have seen frustration and headaches with our members associated with the CFDA registration at the recent RAPS meeting in San Jose. To help alleviate the frustration experienced with medical device CFDA registration, I have started this chain of discussion and promise to get back to you with your solution.

Some of the frustration could be avoided if the right path has been taken.  I attended the 3 full day RAPS CFDA version in China and saw more changes coming. Since 2015, more than 100 regulations have passed from the central government mandates to CFDA requirements resulting in the biggest shakeup since 2000. The changes impact not only pre-market submission but also registration process evaluation, distribution management, promotion and post market monitoring. Please free to post your questions.

Having been in medtech for 20+ years between U.S. and China, I have seen frustration and headaches with our members associated with the CFDA registration at the recent RAPS meeting in San Jose. To help alleviate the frustration experienced with medical device CFDA registration, I have started this chain of discussion and promise to get back to you with your solution.

Some of the frustration could be avoided if the right path has been taken.  I attended the 3 full day RAPS CFDA version in China and saw more changes coming. Since 2015, more than 100 regulations have passed from the central government mandates to CFDA requirements resulting in the biggest shakeup since 2000. The changes impact not only pre-market submission but also registration process evaluation, distribution management, promotion and post market monitoring. Please free to post your questions.

What can you tell me about CFDA and clinical evaluations of the non-clinical trial variety that is required under the EU MDD?  Does CFD require clinical evaluation reports?  If not required, does it accept them as a method for design validation for some types of devices?

Having been in medtech for 20+ years between U.S. and China, I have seen frustration and headaches with our members associated with the CFDA registration at the recent RAPS meeting in San Jose. To help alleviate the frustration experienced with medical device CFDA registration, I have started this chain of discussion and promise to get back to you with your solution.

Some of the frustration could be avoided if the right path has been taken.  I attended the 3 full day RAPS CFDA version in China and saw more changes coming. Since 2015, more than 100 regulations have passed from the central government mandates to CFDA requirements resulting in the biggest shakeup since 2000. The changes impact not only pre-market submission but also registration process evaluation, distribution management, promotion and post market monitoring. Please free to post your questions.