Template of medical device compliance
1.Free template for Chinese registration of medical device
In this FREE starter-kit for Chinese registration, you will get:
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Regulations on the Supervision and Administration of Medical Devices
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Administrative Measures for Medical Device (IVD) Registration and Filing
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Guidance of Chinese labelling
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Guidance of the Administration of Overseas Inspection of Pharmaceuticals & Medical Devices
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Provisions for Medical Device Adverse Event Monitoring and Re-evaluation
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Checklist of Chinese agent
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Workflow of Chinese registration
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Feasibility checklist to register medical device in China
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2.Strategic pre-market kit of medical device for China
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In this session of templates it applies to manufacturer who might never have registered medical device or want to register new medical device in China.
It includes:
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Prof. feasibility checklist to register medical device in China with feedback in term of gap analysis
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Checklist to Chinese agent and distributor
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Prof. workflow of Chinese registration with timeline including review time by authority
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List of Chinese technical documentation
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Example of product technical requirement
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199 EUR
3. All about medical device registration in China
In this session of templates it is primary for experienced regulatory affairs manager who has approved medical device in China. It focuses on technical documentation.
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List of Chinese technical documentation with requirement
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Template of essential principle of safety and performance
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Prof. workflow of Chinese registration with timeline including review time by authority
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Checklist of Chinese instruction for use and label
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Example and template of product technical requirement
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Procedure of type testing
249 EUR
4. Type testing packet in China
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Do you have trouble to prepare testing of medical device in China and maintain testing specification? It is dedicated for experts who want to optimise the most difficult part at Chinese registration.
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Example of product technical requirement
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Template of product technical requirement
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Procedure of type testing
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Match of product technical requirement with related registration documents
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199 EUR
5. After approval activities in China
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It is all about activities after product approval. It includes post market surveillance and also quality managements:
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Match of critical items at Chinese certificate with related documents
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Procedure and template of design change in China
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Template of annual quality management report
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Template of periodic risk evaluation report
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Procedure and template of Chinese vigilance
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Matrix to monitor Chinese registration (Excel)
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Checklist of overseas inspection
299 EUR
6. International registration
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Are you willing to mark medical device in other critical and important market? We can support with following knowledge:
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Important law and regulation in MDSAP countries and in Taiwan
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Feasibility checklist to register medical device in US, Australia, Brazil, Japan and Canada
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Checklist to choose legal representative and international distributor
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Template of regulatory requirement (gap analysis to start international registration)
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Procedure of international registration
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Matrix to monitor international registration
249 EUR
7. Select your choice from design to production, from quality management to regulatory affairs
You can select also each template with price 49 Euro.
We have also template in below:
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Safety declaration (adverse event and recall)
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Marketing history (registration, sale)
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Testing plan, testing report and testing evaluation
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Design history file, device master record, Design transfer report
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Certification of analysis
Alternative you can choose any topic in E-Learning with videos and tests. We will deliver what you inquire to fulfil customer need. By ordering over 200 EUR, there is a 45 min free consulting meeting.