June 12, 2018

This month’s updates include the "Internet+Medical Health", “the Special Approval Procedure for Innovative Medical Devices”, “the Revision Plan of Medical Device Standards” among others. All information you need to know has been put in a nutshell:

1.  China Government Plans to Promote the Development of "Internet+Medical Health"

1. 中国政府は「インターネット+医療」の発展を後押しする見込み

The China government enthusiastically promotes the development of internet + medical health. Three main directions has been proposed, and national institututions were asked for follow up. Some of medical devices technology were also taken as priority. 


Full text can be accessed here


2.  CNDA Publishes a Revision Draft of the Special Approval Procedure for Innovative Medical Devices, and Seeks for Public  Opinion

2. CNDAは革新的医療機器の特別承認手順の改定案とパブリックオピニオンを発表

CNDA revises the special approval procedure for innovative medical device, which scope covers for “The applicable classification of devices”, “Patent effective period”, “Changes in procedure”, among others. This revision is expected to take effect on October 1, 2018.


Full text can be accessed here


3.  CNDA Publishes FY 2018 the Revision Plan of the Medical Device Standards

3. CNDAは2018医療機器基準の改定計画を発表

On May 15, CNDA has released a revision plan of medical device standards, which covers for IVD, non-active and active device, EMC and UDI. Moreover, a considerable number of domestic enterprises have joined this revision planning. It’s foreseeable that many standards will be revised this year.


Full text can be accessed here.


4.  CNDA has Published a Draft Guidance for Online Submission for Medical Device Registration, and is Currently Seeking for Public Opinion

4. CNDAは医療機器登録のオンライン申請についての草案を発表した、またそれに関してのパブリック・オピニオンを募集

CNDA has formally announced its plans to change the current process of registration application to the online submission system, as this would enhance the efficiency of submission qualification. Currently, CNDA has published the draft of the guidance in order to introduce this online submission system. It’s better to understand this new system in advance!


Full text can be accessed here.


5.  Further Notice from the Hainan Government on “Supervision Regulation of Emergency Medical Devices in Hainan International Tourism Area”

5. 海南政府の「海南国際観光区における緊急用医療機器の監督法」

“The Supervision Regulation of Emergency Medical Devices in Hainan International Tourism Area” has received a great interest from foreign manufacturers when it was released in last week of April. This time, the Hainan government has published further details on this regulation with the objective of providing the applicant with concrete requirements.


Full text can be accessed here.


6.  Notice from CNDA on the Amendments of Submission Documents for Renewal and Clinical Trial Application

6. CNDAは更新登録申請と臨床試験申請のための提出書類の改定を発表

Due to the increased volume of renewal and clinical trial applications, CNDA decides to modify some requirements, with an aim to optimize efficiency of the approval process. This notice was issued at the end of May. Moreover, CNDA currently seeks for public opinion with regards to this matter.


Full text can be accessed here.


7.  The CNDA Issued a Notice on the Classification of Intense Pulsed Light (IPL) Device for Hair Removal

7. CNDAは脱毛目的のIPL機器の分類に関する通知を発表

With the sound development and established technology of IPL device in domestic, the CNDA starts to expand its scope with the management of the same. From the time of this writing, - IPL devices for hair removal shall fall under Class II medical devices. This decision has provided more opportunities to many manufacturers in the expansion of the cosmetic industry in China.


Full text can be accessed here.