New clinical trial exempt list, self-testing instead of local testing, acceptance of overseas clinical data ... The week 44 of 2017 is a wonderful week for people working on the CFDA registration, it has been a long time we haven’t got many good news like the ones we get this week. Given the other regulation changes that we have endured recently, having three good news in one single week, it is almost too beautiful to be true!
1. The third wave of medical devices exempted from clinical trial in China
According to the CFDA announcement n° 2017-170, published the 31 October 2017 (link in Chinese), 164 products are exempted from clinical trial in China, effective immediately.
You can find the list of exempted products in the appendices of this announcement:
Appendix 1 List for exempted class II medical devices (37 products)
Appendix 2 List for exempted class III medical devices (11 products)
Appendix 3 List for exempted IVD reagents (116 products)
As always, only Chinese version is published, I won’t translate the entire list, but if there is a specific device that interests you, please feel free to leave a comment, I will try to look it up and let you know.
2. <Medical Device Supervision Regulations> Amendment (Exposure Draft)
This exposure draft of <Medical Device Supervision Regulation> Amendment is published the 31 October 2017, (link in Chinese), the changes are major. Once these amendments become effective, it is going to significantly simplify the process of CFDA registration.
Please find two of them below:
Text deleted from the old version; Italic: New text added in the exposure draft)
Article 14, the 3rd paragraph:
"Product testing report in the application file for Class II or Class III medical device registration
should be provided by a medical device testing establishment could be a self-testing report from the applicant or a testing report provided by an authorized qualified medical device testing establishment. Clinical evaluation document should include clinical trial report, except the medical devices exempted from clinical trial according to the Article 17 of the regulation hereby."
Article 21, the last paragraph:
"If the clinical data obtained out of China conforms to the related requirements for Chinese medical device registration, such data can be used in the registration application in China."
Please note that this amendment text is still in its exposure draft version, let's don’t get excited too early and wait for the official release to open the Champagne.
3. Notice on the use of Chinese language for the applicant name of medical device registration or device listing
The exposure draft of this notice has been published on the 08th august 2017 (link in Chinese), Emergo has made a good summary of this exposure version, so I won’t bother to do it again, you can find the article at the link. In one sentence, all the company name, address and production address need to be translated into simplified Chinese and the translation should be contained in the product label.
If your company doesn’t have a Chinese name yet, you may have a lot of label change to manage in a foreseeable future. It is not a complicate “change control”, but if you have a lot of products affected, it can be a very time-consuming task.
However, the final announcement (CFDA n° 2017-131, link in Chinese, published on the 02nd November 2017) only requires the company name to be translated into simplified Chinese and included in the label, the translation of address is no longer required.
Okay, I agree that the workload for the name change is not necessarily much less than both name and address, but the requirement is much more reasonable.