General information only. Life sciences regulation in China spans NMPA product rules, PIPL/data security, human genetic resources, anti-corruption, volume-based procurement, IP, and clinical trial regimes. Facts, licences, and enforcement practice change. This is not legal advice and does not create an attorney–client relationship. Instruct qualified PRC counsel (and foreign counsel where FDA/EMA/CFIUS paths apply) before you recall product, transfer samples, answer a raid, or file a patent challenge.
Life sciences & healthcare legal cluster: Hub · Dawn raid · VBP · Hospital AR · Exclusive agency · HGR · Trial injury · CRO/CDMO · Device liability · Labeling · SaMD · Patent linkage · License · FDA WL · MDR/IVDR · Internet hospital · Trade secrets · Pharma ads · Device distribution · Sources · Checklist
A. Product, labeling & vigilance
- China IFU/label version control with approval history — labeling & ADR.
- Complaint → PV/vigilance → recall decision tree tested in tabletop — device liability.
- Explant / sample retention SOP with chain-of-custody forms.
- Advertising and HCP materials medical-legal review log — device ads / pharma ads.
B. Clinical, HGR & vendors
- HGR assessment before FPI and before any outbound sample/data — HGR.
- Trial insurance certificates match protocol and sites — trial injury.
- CRO/CDMO audit rights and integrity step-in clauses current — CRO/CDMO.
- Cross-border clinical data path chosen (assessment / SCC / other) — clinical data.
C. Anti-corruption & channel
- Dawn-raid binder and hotline tested — dawn raid.
- CSO/speaker-fee portfolio substance review quarterly.
- VBP award → distributor contract heat-map within 14 days — VBP.
- Hospital AR escalation playbook with tender supply constraints documented.
D. Digital health & data
- Intended use vs wellness claim gate for software — SaMD.
- Model versioning and hospital override logs enabled before go-live.
- PIPL DPIA for health data processing; subprocessors listed.
E. IP & deals
- Patent register watch + linkage response calendar — patent linkage.
- R&D exit trade-secret & device checklist for key scientists.
- Licence milestone definitions bilingual; royalty audit pack ready — licensing.
- Tax/SAFE payment path validated before first cross-border invoice.
F. Governance
- Named owners: PV, HGR, anti-bribery, data export, IP watch.
- Board/audit committee pack annually on healthcare enforcement themes.
- External counsel list with 24/7 raid and SAE contacts.
Primary law bibliography: Primary sources. Narrative hub: Cluster hub.
G. Outbound, digital channel & talent (Phase 2)
- FDA Warning Letter response owners and counsel shortlist — FDA Warning Letter.
- EU MDR/IVDR certificate and post-market surveillance map for export SKUs — EU MDR/IVDR.
- Internet hospital / online Rx advertising review gate — Internet hospital.
- R&D exit: trade-secret hold + non-compete economics — Trade secrets & non-compete.
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