20 docs tagged with "cn-unique"

Full regulatory obligations of the China Agent under MDSAR 2021 and implementing measures.

NMPA AI/ML algorithm change protocol guidance and requirements for AI-enabled medical devices in China.

Annual self-assessment report obligations for medical device registrants under NMPA.

China's regulatory blacklist and cross-agency consequences for serious NMPA violations.

How to change China Agent — NMPA notification, certificate re-issuance, and continuity obligations.

Introduction to the mandatory China Agent (代理人) role for imported medical devices under MDSAR 2021.

NMPA published list of device categories exempt from clinical trials in China.

Hainan FTP and other pilot zone device import and use policies — China-unique market access pathway.

China's risk-based medical device classification system — Class I, II, and III — and the three-tier authority split.

How overseas manufacturers register medical devices in China through a China Agent.

China's breakthrough device pathway — innovative device designation criteria and application process.

Pre-approval and routine GMP inspections by NMPA, including overseas manufacturer inspections.

5-year certificate renewal process for medical devices in China.

China medical device registration certificate — validity, scope, changes, and re-registration.

When 注册 (registration) vs 备案 (filing) applies — the two market entry pathways for medical devices in China.

Overview of China's medical device regulatory framework — NMPA, CMDE, provincial bureaux, and the three-tier authority split.

NMPA standalone software and AI/ML algorithm change protocol guidance documents.

How NMPA classifies standalone software as medical devices under the 2021 classification rules.

Phased UDI implementation deadlines by device class in China.

Statutory definition of the China Agent (代理人) role under MDSAR 2021 Article 39.