التفاصيل البيبلوغرافية
| العنوان: |
[Brief Introduction to Regulatory Documents of European and American Drug-Device Combinations and Enlightenment]. |
| المؤلفون: |
Luo Q; Center for Medical Device Evaluation, NMPA, Beijing, 100081., Tian J; Center for Medical Device Evaluation, NMPA, Beijing, 100081., Wang Y; Center for Medical Device Evaluation, NMPA, Beijing, 100081. |
| المصدر: |
Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation [Zhongguo Yi Liao Qi Xie Za Zhi] 2020 Mar 08; Vol. 44 (3), pp. 246-248. |
| نوع المنشور: |
Journal Article |
| اللغة: |
Chinese |
| بيانات الدورية: |
Publisher: Guo jia yi yao guan li ju Yi liao qi xie qing bao zhong xin zhan Country of Publication: China NLM ID: 9426153 Publication Model: Print Cited Medium: Print ISSN: 1671-7104 (Print) Linking ISSN: 16717104 NLM ISO Abbreviation: Zhongguo Yi Liao Qi Xie Za Zhi Subsets: MEDLINE |
| أسماء مطبوعة: |
Original Publication: Shanghai Shi : Guo jia yi yao guan li ju Yi liao qi xie qing bao zhong xin zhan : Shanghai yi liao qi xie yan jiu suo, |
| مواضيع طبية MeSH: |
Marketing*, European Union ; United States |
| مستخلص: |
This paper briefly introduces the recent regulatory regulations issued by the European Union and the United States on the drug-device combinations. The contents include the definition of drug-device combinations, the attribute definition process, the registration requirements, the review and approval procedures, the management of production systems, and the post-marketing safety supervision. Some inspirations have been obtained from them for reference by the regulatory authorities. |
| فهرسة مساهمة: |
Keywords: drug-device combinations; enlightenment; supervision |
| تواريخ الأحداث: |
Date Created: 20200705 Date Completed: 20200708 Latest Revision: 20200708 |
| رمز التحديث: |
20240829 |
| DOI: |
10.3969/j.issn.1671-7104.2020.03.012 |
| PMID: |
32621434 |
| قاعدة البيانات: |
MEDLINE |
