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China Legal Guides · National framework

Pharma & Device Anti-Corruption in China: Dawn Raid Response Playbook

An unannounced healthcare inspection becomes manageable when the company can verify the visit, preserve evidence, control the response channel and mobilise the right workstream. Minutes matter more than slogans.

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Operational orientation · Qualified PRC counsel required for fact-specific decisions

Incident switch

Preparing for the next visit? Use the readiness and specialist-route sections below.

Command principle

Control the process, preserve the record. Do not turn a raid response into a second problem.

A strong first response is a controlled operating sequence: identify the authority and scope, designate a liaison, preserve materials, support truthful staff participation, log the interaction, and route the resulting facts to the right PRC workstream.

The on-site response board

A 120-minute sequence for the first visit.

Select a time window to view its control objective. This sequence is orientation, not a substitute for PRC counsel’s direction.

Time on site

Ask to see and record the officials’ credentials and agency, then start the contemporaneous visit log. The objective is procedural clarity, not delay.

Non-negotiable line

Do not delete, conceal, alter or direct others to remove evidence. Process discipline protects the company; improvised clean-up can create a separate obstruction and credibility issue.

Control the room

Three roles. One response channel.

Clear roles prevent contradictory statements, lost records and unmanaged internal communication.

Keep a single calm company voice. Record the authority, request, materials reviewed and next procedural step.

What changes the response

Separate the issue before it separates you.

Name each connected but distinct workstream early so one issue does not overwrite another.

01

Administrative and inspection process

Authority, scope, collection record, statements, procedural rights and follow-up notices.

Inspection track
02

Commercial bribery and individual exposure

Company conduct, responsible persons, healthcare engagement, third-party control and escalation risk.

Risk track
03

CSO, invoices and channel evidence

Contract substance, invoice chain, deliverables, hospital-facing activity and payment documentation.

Evidence track
04

Data, people and communications

Device and data handling, interviews, HR protections, overseas systems and external messaging.

Control track
Before the next visit

Build the 90-day readiness programme.

Mark items for your readiness review. Selections stay in this browser and are not submitted.

Frequently asked questions

Questions teams ask in the first call.

These questions support orientation. They do not replace a response plan, current legal assessment or PRC counsel instructions.

What should a pharma company do when inspectors arrive without notice?

Stay calm, verify official identities, activate the designated liaison channel, cooperate truthfully and preserve all materials. Do not delete, conceal or reorganise devices or documents.

Can academic-conference speaker fees create commercial-bribery risk?

Legitimate scientific exchange is not automatically bribery, but the file should show reasonable market value, a scientific agenda, independent selection criteria and adequate service records.

Can a contract sales organisation model still be used?

The label is not decisive. The company should be able to prove real, verifiable services, personnel, deliverables and compliant hospital-facing activity.

Source station

Pair this operational guide with current official materials and the maintained life-sciences source collection.

Operations library

Open the route that owns the next move.

Each card opens an existing specialist page rather than duplicating its content here.

Incident escalation

When the response needs fact-specific legal command.

Bring qualified PRC counsel into the response when the agency, documents, devices, individuals or a live business decision cannot safely be generalised.

Devices or data are requestedSystem access, mobile devices, overseas data or a collection record is in play.

Individuals are questionedExecutives, sales, medical-affairs or third-party staff face interviews or personal exposure.

A decision is liveSuspension, disclosure, employment, tender or communications choices cannot wait.

Educational information only — not legal advice. Laws, guidance and enforcement practice can change; no lawyer-client relationship is created through use of this page.