The Enlightenment of the Management of EU Notified Bodies to China's Introduction of Third-Party Institutions for Medical Device Supervision

  • Qingqing Hou
  • Yiming Xu
  • Dawei Zhang
  • Yi Liang

Abstract

Objective: By introducing the pilot situation of post-market supervision of medical devices purchased by third-party institutions in Jiangsu Province, China, the problems exposed by them were analyzed. At the same time, it draws on relevant advanced experience in the management of EU notified bodies to provide suggestions for optimizing China's follow-up practices and promoting social co-governance supervision.


Method: Conduct on-the-spot investigations in Jiangsu Provincial Food and Drug Administration, China, conduct interviews with regulators on the progress of the project, and conduct in-depth communication. A large number of inquiries about the relevant research literature of the EU notified body and the laws and regulations promulgated by the EU, and systematic analysis.


Results: In the introduction of third-party agencies to assist post-market supervision of medical devices, the Chinese government still has problems such as lack of relevant laws and regulations, imperfect access mechanisms for third-party agencies, imperfect supervision mechanisms, and backward regulatory informatization construction.


Conclusion: Introducing third-party agencies to assist in the supervision of medical devices can effectively ease the pressure on supervision and supplement supervision resources. It is suggested that the Chinese government learn from the management experience of the EU notified bodies, improve the regulatory legal system, introduce relevant regulations, improve the access mechanism of third-party institutions, improve the supervision mechanism, strengthen the construction of supervision informatization, and build a unified supervision platform.

Keywords: Third Party, Medical Devices, Post-Marketing Supervision, EU notified body, Medical Device Supervision, informatization

Downloads

Download data is not yet available.

References

1. Guiding Opinions of the General Office of the State Council on the Government's Purchase of Services from Social Forces [Internet]. The Central People's Government of the People's Republic of China. 2013 Sep 30 [cited 2022 Jun 30]. Available from:
http://www.gov.cn/zwgk/2013-09/30/content_2498186. htm.
2. Xuanguo Xu, Ying Huang. Separation and Unity of Government and Society: Risks and Governance of Third-Party Evaluation of Government Purchase of Social Services-Based on Evaluation Practice in S City [Internet]. 2017 Mar [cited 2022 Jun 30]; 17(2):70-77. Available from CNKI:
https://kns.cnki.net/kns8/AdvSearch?dbprefix=CFLS&&crossDbcodes=CJFQ%2CCDMD%2CCIPD%2CCCND%2CCISD%2CSNAD%2CBDZK%2CCCJD%2CCCVD%2CCJFN
3. Aiguo Du. Problems and Countermeasures in the Process of Government Bidding and Procurement [Internet]. 2021 Sep 06 [cited 2022 Jun 30]; (10):164-166. Available from CNKI:
https://kns.cnki.net/kns8/AdvSearch?dbprefix=CFLS&&crossDbcodes=CJFQ%2CCDMD%2CCIPD%2CCCND%2CCISD%2CSNAD%2CBDZK%2CCCJD%2CCCVD%2CCJFN
4. Bobo Yan, Zuojun Dong, Guojun Sun. Introduction to EU notified bodies and enlightenment to vaccine safety supervision in my country. J Pharmaceutical Research [Internet]. 2019 Jun 15 [cited 2022 Jun 30]; 38(6):370-372. Available from CNKI:
https://kns.cnki.net/kcms/detail/detail.aspx?dbcode=CJFD&dbname=CJFDLAST2019&filename=SDYG201906015&uniplatform=NZKPT&v=KjIUDIS2HyF5OXlguiIsklTH9cUHro5Nr13EC56fuP8q6OAK1hZQlbYZXHfLZht6
5. Daigle B, Torsekar M. The EU Medical Device Regulation and the US Medical Device Industry. Journal of International Commerce and Economics [Internet]. 2019.Nov. [cited 2022 Jun 30]. Available from:
https://xs.scqylaw.com/
6. Eu. European Parliament and Council. Regulation (EU) 2017/745 of the European parliament and of the council of 5 April 2017 [Internet].2017 Apr 15 [cited 2022 Jul 4] Available from:
https://eur-lex.europa.eu/eli/reg/2017/745/oj
7. Zając R, Božek P. Risk Management at the Notified Body in the Aspect of Its Impartiality. J. Mining Machines [Internet]. 2021[cited 2022 Jul 28]. Available from:
https://yadda.icm.edu.pl/baztech/element/bwmeta1.element.baztech-4f362d17-4039-4256-8885-a746aebcee58
8. EU Commission. Nando (New Approach Notified and Designated Organisations) Information System [Internet]. 2017 [cited 2022 Jul 28]. Available from:
http://ec.europa.eu/growth/toolsdatabases/nando/index.cfm
9. EU Commission. Restoring confidence in medical devices. Action Plan after the PIP scandal tightened control in Europe [Internet]. 2014 [cited 2017 April 19]. Available from:
http://europa.eu/rapid/press-release_IP-14-699_en.htm
10. Pane J, Francisca R D C, Verhamme K M C, et al. EU postmarket surveillance plans for medical devices. J Pharmacoepidemiology and drug safety [Internet]. 2019 Jul 18 [cited 2022 Jul 20];28(9): 1155-1165. Available from:
https://onlinelibrary.wiley.com/doi/full/10.1002/pds.4859
11. Ben-Menahem S M, Nistor-Gallo R, Macia G, et al. How the new European regulation on medical devices will affect innovation. J. Nature Biomedical Engineering [Internet]. 2020 [cited 2022 Aug 20]; 4(6):585-590. Available from:
https://wwwnature.53yu.com/articles/s41551-020-0541-x
12. Poos U, Edelhäuser R. Focus Notified Bodies. New requirements for designation and monitoring. J. Bundesgesundheitsblatt, Gesundheitsforschung, Gesund-heitsschutz [Internet]. 2014 [cited 2022 Jul 20]; 57(12):1362-1367. Available from:
https://europepmc.org/article/med/25373553
13. Wanchun Huang, Jingyi Yang, Ruo Du, Yi Liang. Looking at the post-market supervision and purchase of third-party inspection services for medical devices from MDSAP. J China Medical Equipment [Internet]. 2021 Aug 10 [cited 2022 Jul 11];36(08):138-142. Available from CNKI:
https://kns.cnki.net/kns8/AdvSearch?dbprefix=CFLS&&crossDbcodes=CJFQ%2CCDMD%2CCIPD%2CCCND%2CCISD%2CSNAD%2CBDZK%2CCCJD%2CCCVD%2CCJFN
14. Lei Chen, Meng Li. Discussion on the informatization of medical device supervision in my country. J. China Medical Devices Journal [Internet]. 2017 Jul 07 [cited 2022 Jul 23];041(004):275-278,294. Available from CNKI:
https://kns.cnki.net/
Statistics
9 Views | 7 Downloads
How to Cite
Hou, Q., Y. Xu, D. Zhang, and Y. Liang. “The Enlightenment of the Management of EU Notified Bodies to China’s Introduction of Third-Party Institutions for Medical Device Supervision”. International Journal of Drug Regulatory Affairs, Vol. 10, no. 3, Sept. 2022, pp. 54-60, doi:10.22270/ijdra.v10i3.553.