Foreign Pharmacy

Analysis and Discussion on the Japanese Medical Device Nomenclature (JMDN) Database

Expand
  • (1)National Institutes for Food and Drug Control, Beijing 100050, China; (2)Guangdong Medical Devices Quality Surveillance and Test Institute, Guangzhou 510663, China

Online published: 2020-02-05

Abstract

Objective: To discuss the construction, classification and nomenclature of medical device regulatory databases in Japan in order to provide technical support for the construction of medical device regulation informationization in China. Methods: The structure, classification and nomenclature of Japanese medical device nomenclature (JMDN) databases were analyzed. Results and Conclusion: The establishment and management of the JMDN databases have reflected the facts that the medical device supervision in Japan is linked to the actual situation of the country, and the idea keeps in line with the international regulations and pays attention to the longterm stability and practical operability of the regulations, all of which will provide an important reference for further improving the construction of medical device regulation informationization in China.

Cite this article

Zhang Chunqing, Zhou Liangbin, Wang Yue . Analysis and Discussion on the Japanese Medical Device Nomenclature (JMDN) Database[J]. Chinese Pharmaceutical Affairs, 2020 , 34(1) : 108 -113 . DOI: 10.16153/j.1002-7777.2020.01.017

References

[1] 日本厚生劳动省.药食发第0720022号医薬品、医療機器等の品質、有効性及び安全性の確保等に関する法律第二条第五項から第七項までの規定により厚生労働大臣が指定する高度管理医療機器、管理医療機器及び一般医療機器(告示)及び医薬品、医療機器等の品質、有効性及び安全性の確保等に関する法律第二条第八項の規定により厚生労働大臣が指定する特定保守管理医療機器(告示)の施行について[S]. 2004.
[2] Pharmaceuticals and Medical Devices Agency.一般的名称検索[EB/OL].(2019-06-28)[2019-09-10]. http://www.std.pmda.go.jp/stdDB/index.html.
[3] GMDN Agency. Global Medical Device Nomenclature[EB/OL].(2019-07-11)[2019-09-10].https://www.gmdnagency.org/Terms/Search.
[4] The Global Harmonization Task Force. Principles of IVD Medical Devices Classification[S]. 2008.
[5] The Global Harmonization Task Force. Principles of Medical Devices Classification[S]. 2012.
[6] Pharmaceuticals and Medical Devices Agency.認証/承認基準等検索[EB/OL].(2019-06-28)[2019-09-10]. http://www.std.pmda.go.jp/stdDB/index.html.
[7] Pharmaceuticals and Medical Devices Agency.医療機器情報検索[EB/OL].(2019-07-11)[2019-09-10]. http://www.pmda.go.jp/PmdaSearch/kikiSearch/.
Options
Outlines

/