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The Chinese registration of medical device aligns more with FDA in US and less with MDR in EU. For the technical documentation from manufacturers and review by authority are clear regulations applicable.
We have local office in Shanghai so we can follow all activities directly from China.
- Regulatory strategy
You should check firstly prerequisite to mark product in China, followed by determination of classification (I, II and II) and product code (6 digits). Then a pathway of registration with cost and timeline estimation will be introduced.
The foundation is complex regulations and standards which will be transparently explained.
- Gap analysis
Based on technical documentation in home country, a gap analysis of Chinese dossier with specific requirements will be shown in detail. Ideally you should have ISO 13485 certificate.
- Local testing and clinical evaluation
The extensive unique step at Chinese registration is local testing in which medical device will be sent to an accredited lab to test critical specification. Depending on product code, a clinical evaluation might be needed which is an abbreviated form from the view of European clinical evaluation. More and more clinical trial overseas for high risk product is accepted in China
- Compilation of Chinese electronic technical documentation
The technical documentation to authority should be in Chinese and in electronic form. Below are the main chapters which aligns to Table of Contents” at International Medical Device Regulators Forum (IMDRF).
Chapter Items CH.1 Administrative information Application form ISO 13485 certificate Declaration of conformity as in EU (home country approval) Declaration of conformity of standards and regulation CH.2 Product summary information Device description New: Worldwide notifiable incidents New: Worldwide marketing history CH.3 Non-clinical information Risk management file Product technical requirement Type testing report Software file Pre-clinical study as biocompatibility report Essential safety and effectiveness requirements Shelf life and packaging verification CH.4 Clinical research data Clinical evaluation Clinical study if applicable CH.5 Instructions for use and labels All marketing materials as IFU and labels CH.6 Quality management system General production information quality manual, quality objective and quality policy resource procedure Product realization procedure Design and development procedure Procurement procedure Production and service control procedure Monitoring and measuring procedure Measurement, analysis and improvement procedure QM system (personal, organ chart, layout plan of production site) - Choice of Chinese agent and Chinese distributor
Prior to dossier submission it is last time to decide Chinese agent and Chinese distributor which will be listed in final Chinese certificate. The first role is quite similar to US agent acting as liaison between authority and foreign manufacturer.
- Review by Chinese authority
Manufacturer undergoes acceptance and technical review. For deficiency reply one year time is grated.
- Product approval and post market surveillance
After product approval, foreign manufacturer can release final labelling and place product into Chinese market. The post market surveillance is following with typical vigilance, periodic risk evaluation report and annual quality system report.
- Monitoring of Chinese regulation and product design change
It is a task for the whole lifecycle to follow evolving Chinese regulation. Besides it, it is important to intelligently assess and plan the product design change. Upon significant change, you need a new registration, also called change registration in China.
With the team in Germany, Swiss, Italy and China we can support you in
- Registration of medical device and IVD
- Regulatory strategy
- Outsourced production in China
- Clinical evaluation and clinical study
- Post market surveillance
- Quality management
- Chinese agent
- E-learning, in-house workshop
- Interim management in all kinds of project
- Accompany of Chinese business (fair, investment, establishment of manufacturing site and regulatory or quality team)
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