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
Role clarity: MAH, importer, distributor
Spell out who holds registration responsibilities, who imports, who sells to hospitals, and who maintains complaint/vigilance files. Ambiguous “agent” labels create orphan obligations when NMPA or a plaintiff asks who is the producer/seller.
GTM models
- Importer + multi-tier distribution (mind two-invoice style pressures).
- Exclusive provincial or national distributors with performance covenants.
- Direct hospital sales with 3PL logistics only.
- Online/consumer channels where device class and advertising rules allow — device ads.
Quality agreements that actually work
- Release criteria, deviation notice timelines, right to quarantine.
- Complaint intake, investigation ownership, and regulatory reporting clocks.
- Change control: who approves process/supplier changes affecting China SKUs.
- Recall / field action decision rights and cost allocation — recall guide.
- Audit rights and data access (including temperature and UDI traceability).
Import & supply continuity
Customs classification, inspection, and cold-chain exceptions need ops owners—not only regulatory. Dual-source critical components before tender volume spikes. Keep bilingual packing and IFU version control matched to registration.
Channel economics under VBP
Winning prices rewrite distributor margins and exclusivity assumptions. Within 14 days of award, re-open inventory and territory terms — full playbook in VBP disputes. Hospital AR stress often appears first at the distributor layer — hospital payments.
Diligence on distributors
- Licence scope matching your device class.
- Anti-bribery questionnaire and training evidence.
- Sub-distributor map—unknown tiers are compliance black holes.
- Financial health and parallel-import/diversion history.
Exit & transition
Plan termination, inventory repurchase, and patient/install-base support before signature. See exclusive agency termination.
