Medical Devices and IVD Lawyers in China

A China medical-device or IVD plan should start with intended purpose, mechanism, users, setting and risk, because classification drives registration or filing, evidence, testing, clinical evaluation and the responsible authority. Counsel should then map the registrant or filing party, domestic agent for an overseas applicant, product technical requirements, quality system, manufacturing and suppliers, software and cybersecurity, labels and instructions, import, distribution, advertising, adverse-event monitoring, changes, renewals and recalls. A product sold elsewhere may still require a China-specific classification and evidence strategy, and a change to design, algorithm, site, supplier or intended use can affect the existing approval.

Questions that change the route

What product and intended use are being regulated?

Document components, accessories, software and IVD reagents, intended purpose, indications, specimen or patient population, users, use environment, mechanism, duration and invasiveness; compare the classification catalogue, precedents and boundary with drugs, cosmetics, wellness products, laboratory services or combination products.

Which approval and evidence pathway applies?

Identify domestic or imported status, class, applicant and China agent, registration or filing authority, product technical requirements, standards, testing, clinical-evaluation route, exemptions or trial needs, quality-management evidence, manufacturing site and inspection, language, samples, fees and submission timetable.

How will lifecycle compliance remain aligned with the approval?

Control design and software changes, suppliers and contract manufacture, release and traceability, unique device identification where applicable, labels and instructions, import and distribution partners, online sales and advertising, installation and service, complaints, adverse events, periodic reporting, corrective action, recall, renewal and discontinuation.

Evidence to organize first

• Product architecture, intended-use statement, classification analysis and authority communications; predicate and catalogue research; design, risk, usability, software, cybersecurity, biocompatibility, electrical-safety, performance and stability records
• Applicant, agent, manufacturer and site records; quality-system and supplier files; product technical requirements, applicable standards, test reports, clinical evaluation or investigation file, ethics and consent records, registration or filing dossier and regulator questions
• Approved certificate and change history, Chinese label and instructions, batch and serial traceability, import and distribution contracts, advertising and online listings, complaint and adverse-event logs, vigilance reports, CAPA, field action and recall records

Official orientation sources: Medical Device Supervision and Administration Regulation (2024 revision) · Provisions for Medical Device Registration and Filing · Provisions for In-vitro Diagnostic Reagent Registration and Filing. Source check: 8 October 2026.