Chinese registration of medical device (IVD)
Regulatory strategy
You want to mark your medical device in China. We will provide you a
starter kit with the most important regulations and
checklists to have self-assessment of NMPA registration.
Whether your product is a medical device in China, which product code and classification apply to your product, whether the clinical evaluation and study is needed and which competitors and distributors are existing in the same branch, everything in term of a gap analysis will grant you a wise overview and plan of Chinese commercialization.
Whether it is worthy to have a Chinese supplier, an outsourced production Chinese partner, a multicentre clinical trial in China, another Chinese product variant during parallel development in home country, Chinese requirements in design input, a strategic planning in pre-market intelligence is a must.
Feasibility and user needs are nuts and bolts for manufacturers, they are also in our consulting quality system.
Medical device registration in China
Now you decide to register medical device (I, II, III) in China with us.
We will accompany you in a transparent preparation. From the beginning on you will be clear with general NMPA regulations and product-specific guidance and standards. We will highlight demanding Chinese on-site
type testing and
clinical evaluation.
Our purpose is not only to get your product approved, but also to make next product registration on your own, independent of unnecessary consultation.
Other services
- E-learning, Learning Chinese registration, regulatory softskills and beyond in crtical markets
- Training of Chinese regulation and LEAN workshop of regulatory process
- Due diligence (regulatory expert opinion of M&A either from China or to China)
- Clinical evaluation
- Clinical study
- Type testing, outsourced testing for global registration
- Assessment of significant product changes
- Regulatory update (see example of product specific guidance and regulatory news)
- Post market as adverse event report , period risk evaluation report, annual self-examination report
- Labelling troubleshooting (Label, IFU, UDI, issuance code at customs, authority and hospital in all Chinese supply chain)
- Chinese translation (TD, IFU, regulation and standards) with examination of regulatory view
- Question & answer flat rate
- Audit of Chinese partners compliant to ISO 13485,GMP, GSP
- Contract manufacturing of foreign medical device
Consultation Procedure of Regulatory Affairs Service in China
At the beginning of the cooperation we not only check the completeness of your technical documents with Chinese requirements, but also we want to meet counterpart personnaly. Because the successful registration of medical device at NMPA is based on our interaction .
We are committed to optimising every stage of project with brilliant communication and milestone summary.
You can get a gap analysis in term of regulatory strategy at beginning of project. We bring the best experience to overcome important steps during the preparation, onsite type testing in China and editing of compliant clinical evaluation or study. With our unique compilation tool we guarantee your successful product approval.
