Port communication二类医疗器械都包括哪些？对其安全性、Medical devices whose effectiveness should be controlled。包括X线拍片机、B-ultrasound、microscope、生化仪等都属于二类医疗器械。医疗器械监管条例：第三十条规定：Those engaged in the business of Class II medical devices，The operating enterprise shall file a record with the food and drug supervision and administration department of the people's government of the districted city where it is located and submit the certification materials that it meets the conditions specified in Article 29 of these Regulations.。
第二十九条规定：从事医疗器械经营活动，应当有与经营规模和经营范围相适应的经营场所和贮存条件，以及与经营的医疗器械相适应的质量管理制度和质量管理机构或者人员。
二类医疗器械备案需要提供的资料：
- Copy of enterprise business license
- 法定代表人身份证及学历证明
- 企业负责人身份证明及学历证明
- 质量负责人身份证明及学历证明
- 租赁凭证及租赁合同
- 办公场地平面图及仓库平面图。Related products：二类医疗器械包含哪些？
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