1. 初步评估及准备工作

确认产品分类、注册单元等信息。如无法确认，或存在其他问题，可申请受理前咨询。

2. 准备样品并委托检验

根据产品特征及性能确认检验样品，编写产品技术要求，委托具有资质的实验室进行产品检验，并取得检验报告。根据产品的复杂程度，检验完成时间可持续3-6个月甚至更长。

此外，具有检验能力且符合要求的注册人也可以自行检验。

3. 准备申报资料

根据法规要求准备注册申报资料，进口（含港澳台）II、III 类器械，以及国产 III 类器械需提交国家药品监督管理局(NMPA)医疗器械技术审评中心(CMDE)进行注册申报。申报及审评流程、时限如下：

Registration Process and Timeline

1. Initial Assessment and Preparation

Confirm product classification, registration unit and other information. If confirmation is needed or other issues exist, pre-submission consultation can be requested.

2. Sample Preparation and Testing

Confirm test samples based on product characteristics and performance, develop product technical requirements, find qualified laboratories for product testing, and obtain test reports. Depending on product complexity, testing may take 3-6 months or longer. Additionally, applicant with testing capabilities who meet requirements may conduct testing themselves.

3. Preparation of Registration Documents

Prepare registration documents according to regulatory requirements. For Class II and III imported devices (including Hong Kong, Macau and Taiwan) and domestic Class III devices, submissions must be made to the Center for Medical Device Evaluation (CMDE) of National Medical Products Administration (NMPA) for registration review. The submission and review process and timeline are as follows:

注：其他注册类型（变更、延续等）注册周期可能缩短。注册时限同时取决于补充资料的相关要求及复杂程度（补充资料需在补充资料发出后一年内提交）。

The registration period for other types (change, renewal, etc) may be shortened. The timeline for registration also depends on the requirements and complexity of the additional requirements (the supplementary information needs to be submitted within one year after the supplemental information is issued).