在本周三（3月6日）开始的五次单独磋商中，澳大利亚药品管理局（TGA）根据欧盟医疗器械法规（REGULATION (EU) 2017/745，简称“MDR”）提出了新的医疗器械分类规则。
在这五次磋商过程中，TGA分别提出了澳大利亚目前对五种特定医疗器械类型的分类要求，并建议将新的分类规则纳入现有的澳大利亚医疗器械法规或分类变更。
不存在潜在修订的提案包括三种医疗器械：1）通过吸入方式施用药物或生物制剂的医疗器械；2）用于直接接触心脏或中枢循环系统或中枢神经系统的医疗器械；3）由通过体孔送入人体或施用于皮肤的物质组成的医疗器械。
在其中一次磋商中，TGA提议将“若干旨在澄清问题的修订”纳入符合欧盟MDR相关规定的现行分类规则。通过这次磋商，将由预期在体外与人体细胞、组织或器官储存溶液直接接触或与体外受精培养基直接接触的物质或物质混合物组成的医疗器械归为III类（高风险）医疗器械。而在另一次磋商中，TGA提出了一项监管修正案，旨在将所有有源植入医疗器械及其附件也归为III类（高风险）医疗器械。
这些新提案正是TGA围绕国际监管趋同和协调所作出的努力，特别是考虑到将于2020年5月26日正式施行的欧盟MDR的要求更多也更为严格。
英文原文
TGA Proposes 5 Medical Device Classifications in Line With EU MDR
In five separate consultations opened on Wednesday, Australia’s Therapeutic Goods Administration (TGA) proposed new medical device classifications in line with the EU medical device regulation (MDR).
The consultations consider the current classification requirements in Australia for five specific medical device types and either propose new classification rules to be incorporated into the existing Australian medical device regulations or classification changes.
Proposals without potential amendments include medical devices that administer medicines or biologicals by inhalation, are used in direct contact with the heart, central circulatory or central nervous systems, or are substances introduced into a body via a body orifice or applied to the skin.
A consultation that proposes incorporating “a number of clarifying amendments” into current classification rules for EU MDR alignment would classify medical devices that are substances or a mixture of substances for in vitro use in direct contact with human cells, tissues and organ storage solutions and IVF media into Class III (high risk). Another consultation proposes a regulatory amendment to classify all active implantable medical devices and their accessories into Class III (high risk), as well.
The new proposals form part of the agency’s efforts around international regulatory convergence and harmonization, particularly considering the increased requirements MDR will introduce by 26 May 2020
