(e) to contribute to the development of device standards, of CS and of scientificguidelines, including product specific guidelines, on clinical investigation of certain devices in particular implantable devices and class III devices; (e) 协助制定器械标准、通用规范和科学指南,包括关于某些器械,特别是植入...
3.1 The manufacture of sterile products is a complex activity that requires specific controls and measures to ensure the quality of products manufactured. Accordingly, the manufacturer’s PQS should encompass and address the specific requirements of sterile product manufacture and ensure that all activitie...
21、 the duly substantiated request of a MemberState, having consulted the Medical Device Coordination Group (MDCG), decide on a case-by-case basis whether or not a specific product, category or group of products falls within the scope of this Regulation. When deliberating on the regulatory st...
Such an occurrence should be regarded as a potential quality defect and investigated in line with the guidance in? \o 欧盟GMP通则 Chapter 8?of EudraLex, Volume 4, Part I. 1.5.7 Different imported finished product batches may originate from the same? \o 分类:待包装产品 bulk product?batch....
the Commission should be allowed to, on its own initiative or at the duly substantiated request of a Member State, having consulted the Medical Device Coordination Group (‘MDCG’), decide on a case-by-case basis whether or not a specific product, category or group of products falls within...
guidance in Chapter 8 of EudraLex, Volume 4, Part I. 1.5.7 Different imported finished product batches may originate from the same bulk product batch. The QPs certifying the different finished product batches may base their decision on the quality control testing of the first imported finishe...
appropriate.Thesiteswhichareconsideredtohavespecificimportation responsibilitiesinrelationtoamedicinalproduct,abulkoranintermediate product,are: a)SiteofPhysicalImportation. b)SiteofQPcertificationofimportedmedicinalproductsorQP confirmationforbulkorintermediateproductsundergoingfurther ...
5. Specific additional procedures 5. 特别的附加程序 5.1. Assessment procedure for certain class III and class IIb devices 5.1. 某些第III类和第IIb类器械的评估程序 (a) For class III implantable devices, and for class IIb active devices intended to administer and/or remove a medicinal product as...
(‘MDCG’), decide on a case-by-case basis whether or not a specific product, category or group of products falls within the scope of this Regulation. When deliberating on the regulatory status of products in borderline cases involving medicinal products, human tissues and cells, biocidal...
The draft "Submission of Quality Metrics Data Guidance for Industry" was issued in November 2016. The FDA wishes that, after it has come into force, manufacturers will submit defined quality metrics to the FDA via an electronic portal. The FDA will use these to calculate specific statistics whi...