title: [Great significance of accelerating publishing medical equipment supervision and management regulations (amendment)].
abstract: Since medical equipment supervision and management regulations (Amendment) started modification in 2005, 7 years have passed. A few days ago, the Legal Affairs Office of the State Council issued Amendment Third Draft. After studied the draft, we feel it suits the medical device regulatory practice, has a new look, and introduces many new regulatory concepts, with innovative administrative license and regulatory design, of course, the new regulatory regime will inevitably initiate many new problems, explore some new system design. Therefore, based on preliminary interpretation, we publish some experiences, throw away a brick in order to get a gem.
authors.affiliation: Shanghai Municipal Food and Drug Administration Division of MD, Shanghai, 200010. yuwei@smda.gov.cn
authors.forename: Wei
authors.initials: W
authors.lastname: Yue
mesh_terms: D004864:Equipment and Supplies / Q000592:standards*; D033161:Government Regulation; D011643:Publishing / Q000331:legislation & jurisprudence / Q000458:organization & administration*