Services across the full product lifecycle

1. Registration Consulting & CRO Setup

This step is free of charge. Most suppliers price regulatory consulting, project assessment, classification and dossier guidance separately, typically in the RMB 50,000–100,000 range. We place this work before the cooperation begins, at no additional cost.

What is included

• Product classification — determining whether the device is Class I, II or III under the Medical Device Classification Catalogue and classification definition documents. Classification is set by regulation, not chosen by the company or the supplier.
• Intended use and scope review — the starting point of pathway planning; a change in name or intended use can change the class.
• Registration pathway planning — defining the evidence route and breaking down the dossier and validation lists with a timeline.
• Dossier writing and logical review — technical requirements, research data, risk management reports and submission documents, including gap checks.
• Quality system setup — quality manual, procedures and records: who is responsible, when to act, what evidence to keep.
• Deficiency response — response strategy and supplementary data when review questions arise.
• Inspection readiness — rehearsal against review logic, closing findings in advance.

2. Product Testing

Testing at accredited laboratories, producing formal test reports. Testing is performed by third-party institutions and billed according to the actual test items, with invoices provided.

• Full performance testing against technical requirements
• Electrical safety and EMC (active devices)
• Biocompatibility evaluation (body-contacting devices)
• Physicochemical, sterility and microbial limits
• Stability and shelf-life verification

3. Sterilization Validation

For sterile devices, the chosen sterilization method must be demonstrated as safe and effective, and shown not to impair product performance — an essential part of the registration evidence.

4. Transport Validation

Simulating the vibration, drop, stacking and temperature/humidity exposure of real distribution, proving the packaging system and sterile barrier remain intact and protective.

• Vibration — continuous vibration during transport
• Drop — impact during handling and loading
• Stacking and compression — warehouse stacking loads
• Temperature/humidity cycling — where applicable to the distribution environment

5. Contract Manufacturing (CDMO)

Under the Marketing Authorisation Holder system, companies keep brand and product ownership while production is delegated to a qualified facility with cleanroom capability. We undertake pilot and volume production, quoted per product and volume.

• Process lock-down — fixing R&D parameters into repeatable work standards
• In-process control — critical parameters, environmental monitoring and operator practice
• Pilot and volume batches — batch consistency and yield
• Release management — batch record review, release decision and retention samples
• Change management — assessment and records for material, process and supplier changes

6. Class I Filing

Class I medical devices are subject to filing at the municipal level of the drug regulatory authority. Filing is a formal review for the record, and the outcome is a filing certificate — not a "registration certificate".

7. Manufacturing Licence

Contract production requires the corresponding manufacturing licence. We support the application process, covering site conditions, personnel qualifications, system documentation and submission materials.

Verifiable credentials: all licences and certificates can be verified publicly by number on the NMPA website, provincial drug regulatory authority websites and issuing bodies' websites. We encourage clients to verify independently, and welcome site visits.

Product Categories Covered

Class I, II and III medical devices, including innovative and improved devices, from low-value consumables to implantable high-value products.

Indicative Cost Reference

The ranges below are market references; the actual figure depends on device class, test items and completeness of existing documentation. A formal quotation is provided as a written list after assessment and before signing.