DocMCP Knowledge BaseOpen Medical Device Regulatory Knowledge

Bilingual: Available in both Chinese and English
Structured: Stored as Markdown + JSON for machine consumption by DocMCP
Verified: Source URLs verified against official regulatory bodies
Open: Licensed under CC BY 4.0

EU MDR | FDA | NMPA | International Standards

EU MDR / IVDR

Regulations, harmonised standards (OJ), MDCG guidance documents, TEAM-NB position papers

21 CFR regulations, FDA-recognized consensus standards (AAMI/ASTM), guidance documents

Chinese regulations, GB/YY standards, registration review guidance principles by device category

ISO/IEC standards applicable across multiple regulatory frameworks (ISO 14971, IEC 62304, etc.)

This is an open regulatory knowledge base for medical device compliance, maintained by RASAAS and the community.

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