Compliance of online sales of medical devices

Compliance of online sales of medical devices：Processing conditions、List of Materials and Official References

医疗器械网络销售合规由深圳市市场监督管理局（网络销售备案）＋ 通信管理部门（网站/APP 备案）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：

• 通过自建网站、APP、小程序或第三方平台销售医疗器械的企业
• 已取得经营许可/备案，需补充网络销售备案的企业

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

• 仅做产品展示、不提供在线交易与支付的企业（仍受广告与信息发布规则约束）
• 仅向医疗机构直销、不走网络渠道的企业

Core Conditions (Checked Item by Item)

1. 已取得 corresponding 经营许可或备案，且网络销售品种在许可范围内。
2. 自建网站需完成 ICP 备案（经营性网站需 ICP 许可），APP/小程序需完成相应备案。
3. 具备在线交易记录、购销存追溯与售后服务能力。
4. 在网站首页或经营活动主页面显著位置公示许可证或备案凭证信息。

List of materials and common return points

Review and On-site Inspection Focus Points

• 第三方平台开店不能替代企业自身的网络销售备案。
• 销售页面出现“治疗”“根治”等表述，属广告违法高风险点。
• 冷链品种网售需说明运输温控方案，否则核查难以通过。

time limit、Validity Period and Subsequent Obligations

Cost structure (listed separately)，Avoid vague punches

备案不收费；网站合规改造、等保测评按第三方实际收费。

Risk and Responsibility Boundaries

• 无备案网售医疗器械，可能被责令下架并处罚。
• 销售第三类器械但许可范围不含该品种，属超范围经营。

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.。