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Legal Medical Device Agent in China Market

发布时间:2020-06-20 浏览次数:837

Medical Device Agent in China Market

Medical Device entering the Chinese marketoffers tremendous opportunity for medical device companies, but it is notwithout challenges. Having a partner with experience and expertise in theChinese marketplace is essential. It can be the difference between success andfailure. Our experienced consultants can provide insight and guide you throughthe NMPA regulatory process as Medical Device Agent in China.

The role of Medical Device Agent in China

Ⅰ Pre-market of medical device: To manage the registration process with NationalMedical Products Administration (NMPA) on behalf of medical devicemanufacturer, to be the conjunction between NMPA and manufacturer incommunications with the foreign establishment and product registration.

Ⅱ Post-market of medical device: To communicate with NMPA or related partieson behalf of medical device manufacturer,responding to questions concerning theforeign establishment´s devices that are imported into China market, to assistthe investigation to medical device adverse event.

Medical Device and IVD Registration inChina

Medical devices are regulated by the NMPA,which isunder State Administration for Market Regulation. Manufacturers must registertheir devices with the NMPA before selling or distributing in China. The NMPAreviews all device applications and has strict requirements for submissiondocumentation, testing and clinical data.

NMPA Medical Device RegistrationSubmissions and Device Classification

Your device classification determines thedocumentation required for your NMPA submission. Classification is based on NMPAregulation and the NMPA classification database. Device classification andtheir registration requirements are as follows:

Class I –registration dossier – selftesting reports

Class II –full registration dossier andtechnical review

Class III– full registration dossier andtechnical review and clinical data

Manufacturers must submit a technicaldossier that includes detailed technical information, clinical data and qualitydocumentation. China requires in-country testing for all Class II and IIIdevices, although the NMPA may accept some of your existing testing reports.Testing requirements vary depending on your device type.

We can Identify NMPA Testing and Clinicaldata Requirements in China

Bonnier is fully equipped to help you complywith Chinese testing and clinical conformity requirements for your devicebefore you start the registration process. Here´s how we can help:

1.Provide initial assessment to determineregistration requirements and suggested clinical conformity route

2.Assist with identifying qualified testingcenters in China and establishing the product technical requirement

3.Perform clinical literature review and prepareyour CER, if needed

4.Advise you regarding clinical datarequirements if you must perform clinical trials in China

5.Prepare registration submissiondocumentation and submit to NMPA

6.Medical Device Agent in China to keep thecompliance with NMPA regulation consistently

China Medical Device Regulatory StrategyReport

China´s medical device market is regulatedby NMPA, which is under State Administration for Market Regulation. All medicaldevices must receive NMPA approval before they can be marketed in the country,though Class I devices are subject to a simpler notification process.

Let Bonnier Assist You in NavigatingMedical Device Registration in China and the Approval by NMPA.

Bonnier relies on our in-house consultantsas well as industry and regulatory contacts, to provide your Regulatory Pathwayservice. We offer incisive, actionable analysis including:

1.NMPA Regulatory Background

2.Product Assessment Based on NMPA criteria

3.Device Classification

4.Medical Device Registration Requirements

5.Labeling and Language Requirements

6.Costs and Timeframes

7.Post-Market Vigilance Requirements

Main Business for Bonnier:

1.Consultant Service for ISO13485 QualityManagement System

2.Consultant Service for the Medical DeviceSingle Audit Program (MDSAP)

3.Consultant Service for FDA CFR820 RegulationRequirement and Accompanying Service of Factory Auditing

4.Overworld Medical Device RegistrationService, Including USA 510k, Europe CE, Canada MDL and NMPA Registration

5.Medical Device Post Market Service, asMedical Device Adverse Event Reporting, Post-market Clinical Follow-up Serviceetc.

6.Training for Medical Device Regulationand Quality Tools, as MDSAP regulation, EU MDR, CAPA System, Verification &Validation, Medical Device Risk Management etc.

7.The service of Medical Device Agent inChina will assist oversea Medical Device Manufacturer on registration in Chinafor classⅠⅡⅢ Medical Device and on regulationcompliance in China

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