Regulatory Analysis

In-depth analysis of medical device regulations, standards interpretation, and compliance strategies.

25 articles | Last updated: 2026-02-23

Article	Topic	Year
NMPA Notice 2024 No.120 — 34 New Medical Device Industry Standards	Standards	2024
NMPA Notice 2024 No.92 — 36 New Medical Device Industry Standards	Standards	2024
Abolished Standards	Standards	2025
Medical Device Compliance Document Translation Assistant Guide	Tools	2024
Cleanroom Compliance: ISO 14698 vs EN 17141	Standards	2025
Chinese Pharmacopoeia 2020 vs 2025: General Rules 1105 & 1106 Comparison	Standards	2025
Cybersecurity Lifecycle for Medical Devices	Cybersecurity	2024
EU MDR UDI Implementation Guide	EU MDR	2025
GB 9706.1-2020 and Collateral/Particular Standards Implementation Notice	Standards	2023
GSPR 10.4.1 and CMR Substances	EU MDR	2025
Hong Kong Medical Device Market Access & Regulatory Compliance Guide	Market Access	2025
ISO 13485 QMS: In-Depth Analysis & Best Practices	QMS	2025
Active Medical Device External Marking Requirements	Labeling	2023
Medical Device Software and GB/T 25000.51 Testing	Software	2025
New Standards Published	Standards	2025
NMPA Notice 2025 No.30: Driving Localization of Medical Device Industry	NMPA	2025
Building an Intelligent PDF Document Translation Platform	Tools	2025
Residual Risk in Medical Devices: Risk Management and IFU Implications	Risk Management	2025
State-of-the-Art in Medical Devices	Clinical Evaluation	2023
Standards Amendments	Standards	2025
Sterility and Chemical Testing Sample Quantities	Testing	2023
Thailand Medical Device Market Access & Regulatory Compliance Guide	Market Access	2025
NMPA Usability Engineering Guidance Application Notes	Usability	2024
How to Write a Clinical Evaluation Report: IMDRF Clinical Evaluation Guide (2019)	Clinical Evaluation	2023
Mesh Nebulizer Design Technical Parameters	Device Design	2023

INFO

Articles link to the Chinese version. English translations are in progress for selected articles.