T/SZAMDI 001.2-2024 Active Group standards

T/SZAMDI 001.2-2024 Medical Device Company Trade Secrets - Part 2: Compliance Risk Management Standards

Publish Date: 2024-09-19 Implement Date: 2024-09-23 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/SZAMDI 001.2-2024

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Integrated

ICS Name: The comprehensive organization and management of the company (enterprise)

Publish Date: 2024-09-19

Implement Date: 2024-09-23

Scope

Scope: This document stipulates the basic requirements for compliance management of trade secrets, types of compliance obligations, identification, confirmation, and implementation of compliance obligations, compliance risk management systems and measures, compliance risk early warning, compliance risk handling, and inspection and improvement, etc. This document is mainly applicable to the compliance risk management of trade secrets for medical device production and operation enterprises (hereinafter referred to as "enterprises"), and can also be used as a reference for the compliance management activities of trade secrets for other technology-based and innovative enterprises in industries such as biomedicine, electronic information, equipment manufacturing, and advanced materials. Main technical contents: 1. Scope 2. Normative reference documents 3. Terms and definitions 4. Basic requirements 5. Types of compliance obligations 6. Identification, confirmation, and implementation of compliance obligations 7. Compliance risk management systems and measures 8. Compliance risk early warning 9. Compliance risk handling 10. Inspection and improvement