26 docs tagged with "pre-market"

Electrical safety, EMC, and software requirements for active medical devices in China.

How NMPA handles products at the boundary between medical devices, drugs, cosmetics, and food.

The Class I medical device filing process with district or municipal authorities in China.

The Class II medical device registration process with provincial NMPA bureaux in China.

The Class III medical device registration process with national NMPA and CMDE technical review.

Classification rules for in vitro diagnostic reagents under China's IVD regulatory framework.

How NMPA classifies medical devices using the National Medical Device Classification Catalogue (NMDCC).

Clinical evaluation pathways for medical device registration in China — trial, literature, and exemption.

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

Requirements for conducting medical device clinical trials in China under NMPA GCP.

Drug-device and device-biologic combination products under China's regulatory framework.

Custom-made device exemptions and obligations under MDSAR 2021 in China.

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

Implantable medical device requirements in China — Class III default, biocompatibility, long-term performance.

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

Registration pathway for in vitro diagnostic reagents under NMPA Order No. 48.

How to read and use the NMPA National Medical Device Classification Catalogue.

Additional requirements for radiation-emitting medical devices in China — MEE and CAEA approvals.

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

Technical documentation requirements for medical device registration in China.

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

Single-use device obligations — reprocessing prohibition, labelling, and enforcement in China.

NMPA classification rules for standalone software and SaMD, IEC 62304 requirements in China.

Sterilisation validation, sterile barrier, and EN/ISO standards for sterile medical devices in China.

Equivalence-based clinical evaluation for Chinese medical device registration — comparing to a same-kind predicate device.

How CMDE reviews Class III and imported medical device registration dossiers.