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China Regulatory Affairs: Imported Medical Device

Key stakeholders, value chain analysis, SFDA requirements, timeline & costs

Report Overview

China ranks as the world's third largest medical device market. By 2014, the expected value of China medical device market will reach US$28 billion. The majority of Chinese consumers trust imported medical device over domestic ones, because they believe that the imported devices are more reliable and less likely to malfunction. Foreign medical device manufacturers have an opportunity to take advantage of this perceived brand value to build a presence in this huge market.


For imported medical device to be sold in China, it must be registered with and have its label approved in one of the 3 classifications endorsed by the SFDA. For foreign medical device manufactures it is of key importance to understand the SFDA requirements and how with up-to-date information their products can reach the market.


This report starts with the introduction of medical device definition(s) in China, the 3 classifications defined by the SFDA as responsible authority for the registration. It also presents the key stakeholders, value chain analysis, timetable, costs, required documents and test items for the imported medical device registration. This report will be helpful for companies wishing to bring successfully imported medical device brands to the China market.


Key Report Features

Definition of medical device in China
Regulation and responsible authority for medical device registration
Classifications of medical devices
Key stakeholders and value chain analysis for imported medical device registration
Imported medical device registration process
Imported medical device registration timetable and costs
Required documents for imported medical device registration
Test items for medical device registration
Clinical trials requirements for medical device registration

The report contains 17 pages in Chinese presentation format. English version will be charged additionally.


Who Would Benefit From This Report?

Regulatory affairs director/manager
Business development director/manager
Chief marketing officer
Marketing director responsible for the business
Other players in the Medical Device industry
Researcher and financial analyst in the life science industry
Private and institutional investors in the life science industry

Publication date

August 20, 2012


Price

5,000 RMB / 800 USD for Chinese / English report

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A/C: Shanghai Loudon Marketing Consultant Co., Ltd
A/C: No. 444259223258
Bank Name: Bank of China Shanghai, FanYu Road Sub-branch
Swift code: BKCHCNBJ300

 

Name Beneficiary：Loudon Far East B.V. The Netherlands
Bank Name：ING Bank N.V.
Account No：67.38.48.906
IBAN：NL23INGB 0673848906
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