T/SHSPTA 003-2024 Retail medical device advertising compliance management specifications for medical device enterprises

Scope

Scope: This document specifies the basic requirements for pharmaceutical product retail enterprises in terms of application, design, production, review, and release of medical device advertisements, as well as compliance management. It clarifies the requirements for advertising-related parties, corporate management responsibilities, advertising management systems, advertising compliance education and training, advertising facilities and equipment, self-evaluation and review processes, file management, and self-inspection and assessment. This document applies to pharmaceutical product retail enterprises (hereinafter referred to as retail enterprises) such as retail chain headquarters, retail chain stores, and standalone retail enterprises engaged in the sale of medical devices. Retail enterprises, such as supermarkets and malls, that also sell medical devices may refer to and implement this document accordingly. Main technical content: 1. Scope 2. Normative reference documents 3. Terms and definitions 4. Requirements for advertising-related parties 4.1 Advertisers 4.2 Advertising operators 4.3 Advertising publishers 4.4 Internet platform operators 5. Corporate management responsibilities 5.1 Responsibilities of retail chain headquarters 5.2 Responsibilities of retail chain stores 5.3 Responsibilities of standalone retail enterprises 6. Advertising management systems 7. Advertising compliance education and training 7.1 Training objectives 7.2 Training content 7.3 Training methods 8. Advertising facilities and equipment 8.1 Offline equipment 8.2 Online media and platforms 9. Self-evaluation and review processes 9.1 Self-evaluation by advertisers 9.2 Review of advertisers and publishers by advertisers 9.3 Review by retail chain headquarters 9.4 Review by retail chain stores 9.5 Review requirements for standalone retail enterprises 10. File management 10.1 Management of advertisers' business files 10.2 Management of retailers' files by advertising publishers 10.3 Manag

Development Information

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