Article 7 Medical device industry organization shall strengthen the industry self-regulation, promote the construction of credit system, urge enterprises to conduct production and distribution activities in accordance with the law, and guide enterprises to act in good faith. ...
我国医疗器械风险管理法规现状与发展方向的分析-analysis on the current situation and development direction of chinas medical device risk management laws and regulations.docx,PAGE PAGE 2 第一部分 前言 我国医疗器械风险管理法规现状与发展方向的研究 的要求产生
Food and Drug Administration (FDA) and American patent law as of 2013, and it mentions notifications and the FDA's regulatory authority under the nation's Federal Food, Drug, and Cosmetic Act, as well as information about organizational knowledge for medical device companies. Patentability, ...
《征求意见稿》还提出,国家建立健全医疗器械数据管理制度,同时建立健全医疗器械唯一标识制度等。 The National Medical Products Administration (NMPA) has drafted the Law of the People's Republic of China on Administration of Medical Devices (Draft for...
the validity of existing and valid legacy device certificates by operation of law from the expiry date (even if that date is still in the future) but also – in exchange – makes the article 120 (3b) – (3d) conditions immediately applicable to the device (see conditions discussion below)...
Firstly, the New Regulation has set higher standards for the medical device Registrant/Filing Applicant to establish quality control and whole process quality control system, including without limitation: (1) The Registrant/Filing Applicant...
law provided for this purpose, when acting in the course of providing medical treatment to a patient under his care“recognized standards” means standards deemed to offer the presumption of conformity to specific essential principles of safety and performance of a medical device.“registration holder...
and quality management system documents were not required for filing Class I medical devices. 7 As indicated by a CFDA spokesman, the changes to the documentation requirements do not ease the burden on applicants, but rather places greater responsibility on the applicants to comply with the law. ...
and medical methods in other countries, and familiar with the examiners applying the law. Freedom to Operate is important in the litigious medical device space—Schwegman has developed cutting-edge tools and processes to answer FTO questions “early and often” to mitigate risk before locking in a...
K Griffis - 《Bloomberg Law Ip Law News》 被引量: 0发表: 2022年 Manual Respiratory Therapy Device in Subacute COVID-19: A Case Report There are no recommendations for medical therapy or auxiliary breathing device at an evidence level to prevent symptoms at subacute phase of novel coronavi.....