Class II medical device business record

Class II medical device business record：Processing conditions、List of Materials and Official References

二类医疗器械经营备案由深圳市市场监督管理局（区局）主管。Is it applicable、Handle according to which category of matters，Depends on the subject qualifications、Business activities and actual location/personnel arrangements；Newly established under the same name、change、continue、Cancellation handled separately，Cannot replace each other。

Scope of application：First determine which category it belongs to

Situations that usually require handling：

• 经营第二类医疗器械（如血压计、医用口罩、部分康复器械）的企业
• 同时经营一类、Category II，需要完成备案而非许可的企业

Easily mistaken as needed、But situations that should be verified separately：

• 经营第三类器械（需许可）
• 仅经营第一类器械（一般无需备案）

Core Conditions (Checked Item by Item)

1. 营业执照经营范围含第二类医疗器械销售。
2. 配备质量负责人，具备相关专业学历或职称。
3. 经营场所与储存条件与经营品种相适应。
4. 建立进货查验、销售记录与售后服务制度。

List of materials and common return points

Review and On-site Inspection Focus Points

• 备案为告知性备案，但备案后监管部门会开展核查，条件不符仍会被要求整改。
• 备案地址与实际经营地址不一致，是最常见的问题。
• 同时经营三类器械的企业，应确认许可范围已覆盖相关品种，避免“有备案无许可”。

time limit、Validity Period and Subsequent Obligations

Cost structure (listed separately)，Avoid vague punches

备案不收费；顾问服务费按资料整理与核查陪同范围计。

Risk and Responsibility Boundaries

• 备案不等于许可，不能经营第三类器械。
• 停业或不再经营应主动取消备案，避免被列入异常。

Official Basis and Verification Entry

Date of consultation of the above materials：2026November 12。The provisions of the regulations shall be based on the officially published current text.；Service guidelines have regional differences and version updates，The actual acceptance requirements shall be subject to the standards of the accepting authority at the current period.。

tidy：52 Daiban 郁庭川（医疗器械经营备案顾问）｜内容复核：2026November 12Content Standards and Correction Policy

illustrate：This page is a guide for handling conditions and organizing materials，Does not constitute legal advice、Regulatory approval or approval commitment。Submit application、On-site verification、The issuance of certificates and the decision to open accounts are both independently made by the competent authority or the bank.；Specific scope of services、The costs and deliverables shall be subject to written authorization.。