T/ZAMEI 10-2025 Active Group standards

T/ZAMEI 10-2025 Regulations on the Online Sales Behavior of Medicial Devices

Publish Date: 2025-07-29 Implement Date: 2025-08-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: T/ZAMEI 10-2025

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: -

ICS Name: Integrated medical equipment

Publish Date: 2025-07-29

Implement Date: 2025-08-01

Scope

This document provides compliance norms that all parties involved in online sales of medical devices should follow when conducting online sales activities. It applies to operators of online sales of medical devices, e-commerce platform operators providing services for online transactions of medical devices, and other relevant parties involved in the online sales of medical devices. 1. Scope This document provides compliance norms that all parties involved in online sales of medical devices should follow when conducting online sales activities. It applies to operators of online sales of medical devices (hereinafter referred to as "online sales operators"), e-commerce platform operators providing services for online transactions of medical devices (hereinafter referred to as "e-commerce platform operators"), and other relevant parties (hereinafter referred to as "relevant parties") involved in the online sales of medical devices. 2. Normative Reference Documents This document references GB/T 31524, "E-commerce Platform Operation and Technical Specifications". 3. Terms and Definitions Define relevant terms: operators of online sales of medical devices, e-commerce platform operators providing services for online transactions of medical devices, relevant parties, inspections, and self-inspections. 4. Regulatory and Compliance Requirements for E-commerce Platform Operators Specifies the regulatory responsibilities of e-commerce platform operators for online sales of medical devices, including the principle of consistency between online and offline operations, key risk control and prevention, and qualification information review and management. 5. Compliant Sales and Operations for Online Sales Operators Specifies the obligations and operational requirements that online sales operators should fulfill, covering the entire life cycle management of online sales of medical devices from product display and transaction behavior to after-sales services.

Development Information

Related Standards

GB/T 16886.11-1997 Replaced

GB/T 16886.11-1997 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity

Publish Date: 1997-06-26

GB/T 16886.3-1997 Replaced

GB/T 16886.3-1997 Biological evaluation of medical devices—Part 3:Tests for genotoxicity, carcinogenicity and reproductive toxicity

Publish Date: 1997-06-26

GB/T 16886.6-1997 Replaced

GB/T 16886.6-1997 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation

Publish Date: 1997-06-26

GB/T 16886.1-2001 Replaced

GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing

Publish Date: 2001-09-24

GB/T 16886.13-2001 Replaced

GB/T 16886.13-2001 Biological evaluation of medical devices—Part 13:Identification and quantification of degradation products from polymeric medical devices

Publish Date: 2001-09-24

GB/T 16886.7-2001 Replaced

GB/T 16886.7-2001 Biological evaluation of medical devices—Part 7:Ethylene oxide sterilization residuals

Publish Date: 2001-09-24