Chinese landscape of crticial process for medical device
We accompany a lot of European manufacturers to register medical device and IVD in China.
Due to high professional - and MDR aligned process we encounter many troubles and learned a lot. We try to establish as many process, templates and checklist as possible to make a transparent process landscape dedicated to manufacturer who had went go will go to Chinese market.
For some process we will cover international markets to have a consolidated process or templates for all manufacturers. Start a free consulting with us.
Chinese own process needed?
As we prepare for overseas inspection of Chinese authority, manufacturers like to integrate process in existing process. It is possible however for some key processes is too complex for authority to pick up Chinese requirements.
Besides possible mentioning of Chinese process in superordinate SOP or working instruction, we suggest manufacturer to have own process of
- Product technical requirement
- Type testing
- Technical documentation
- Final inspection at production
- Post market surveillance
Focuses of Chinese dossier
As workflow for registration we illustrate type testing and clinical evaluation (trial) which takes many efforts. Besides depending on product types there are challenges as
- Chinese labelling
- Chinese essential requirement
- Software file
- Shelf life validation
- V&V test compliant t product specific guidance.
- Exact these critical parts must be taken into prioritised account.
Agile management of product registration
There are not many typical steps in project management as step 1 followed by step 2.
We teach you agile project management of Chinese registration below in figure that you can start all independent steps as soon as possible and discover traceability among them.
Instead of process it is useful to have some templates and checklists of critical technical documents which can be acquired by us:
- Device description
- Intended use (related to classification)
- Essential principle
- Shelf life validation
- Software file
- Change assessment in V&V (related to change registration)
Traceability of Chinese process
Exact among technical documentation manufacturers have to trace critical contents and make them consistent:
- Intended Use & device description & application form & clinical evaluation & comparison to previous device
- Specification in PTR & Chinese standard & V&V report & final inspection if applicable
Use of our other services
Either you as manufacturer have approved medical device in China or wish to mark medical device in China, you can book free consulting.
We can work on:
- Post market surveillance
- Optimisation of needed process
- Compile of TD bases on template
- Integrate of changes in running TD
- Design transfer from R&D to production
best sold workshop
Premarket gap analysis
Classification (TP)
List of applied regulation (TP)
Chinese agent and distributor (CL)
Profitableness matrix
Feasibility report (TP)
Regular: 299 EUR
Premium: 399 EUR
*with our approved gap analysis for Chinese registration
Chinese technical documentation
TOC with requirement of TD
Product technical requirement (TP)
Type testing (WI)
Clinical evidence (TP)
Chinese label and IFU (CL)
Chinese labelling (WI)
Device Description (TP)
Essential pricinple (TP)
Software File
Verification report as shelf life (TP)
Quality management (chapter 6, TP)
Regular 499 EUR
Premium: 599 EUR
*inclusive interactive compilation of TD
Review (deficiency reply to approval)
Timeline to review (TP)
Deficiency reply (TP)
Deficiency matrix (TP)
Lessons learned report (TP)
Design transfer (TP)
Traceability of Chinese certificate
199 EUR
Production of Chinese variant
Plant master file (TP)
Inspection (incoming, in-process and final, TP)
Mangement outsouced production (WI)
Article list (BOM, TP)
PTR traced in production (Matrix)c
199 EUR
Quality management
Change assessment (WI, template)
CAPA (WI)
Complaint management (WI)
Adverse event (WI)
Recall (WI)
Training (WI)
Inspection by Chinese authority (WI)
Non-conforming product (WI)
299 EUR
Post market surveillance
Post market plan (AI)
Annual self-inspection report (TP)
Periodic risk evaluation report (TP)
299 EUR
