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Service for the Industry Training and Authentication Consulting Technology and Regulation

Service for the Industry

Management and Services for the Industry
1. To conduct investigations and researches in policies, guidelines and programs of medical instrumentation authorized by the government, bring forward opinions and suggestions to the government and to assist the government in terms of industrial management and services;
2. To exchange opinions and suggestions with the government about the common problems from enterprises, and to assist the government for training, publicizing and implementing of policies;
3. To establish smooth coordination networks to enhance the relationships and cooperation among members, to resolve problems of members and to provide the members with various services;
4. To be responsible for management of members and to update the member database promptly;
5. To be responsible for coordination, communication and guidance in branches and professional committees;
6. To establish and maintain good relationships and cooperation with industrial organizations, commercial divisions of embassies in China as well as a part of famous foreign enterprises so as to provide the international trading opportunities for domestic medical instrumentation enterprises.
Tel: 86-10-51905364, 86-10-51905381,86-10-51905362, 86-10-51905373

Information Consulting Service
1. Industry statistics – CAMDI is responsible for statistics of medical device industry commissioned by the National Bureau of Statistics and the State Development and Reform Commission of China
2. Industry databases – CAMDI is responsible for industrial data collection and database construction.
3. Industry annual report -- CAMDI is responsible for compiling and publishing the industry annual report, which is called China Medical Device Industry Almanac
4. Investment services – CAMDI makes the full use of professional resources as advantages to provide consulting and information exchanging services for various types of investment institutions and member companies Information Consulting Service Tel: 86-10-51905364 86-10-51905362
5. Marketing research – CAMDI provides report services on industrial policies, marketing, industry development trends and forecast, industry research commissioned by government, and other industry research.
6. Communication services – CAMDI provides communication and consultation services on designing, OEM and manufacturing of medical device products among upstream and downstream industries, and OEM companies
7. Science & technology achievement transforming services – CAMDI provides consulting services on science & technology achievement transforming for manufacturers and R & D institutions of medical devices to promote the transformation
Tel: 86-10-51905364, 86-10-51905362

Exhibition and Conference
1. To organize or co-organize various international medical instrument exhibitions and organize enterprises to visit and examine other international medical instrument exhibitions and institutions;
2. To start up various relevant academic forums and commercial affairs on medical instrument;
3. To assist enterprises to get developed in foreign markets and establish an international communication platform for enterprises;
4. To cooperate with solid investment organizations to provide domestic medical instrument enterprises with special financing platforms as well as relevant services. Subdivision of Exhibition and Conference
Tel: 86-10-51905381,86-10-51905373
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Training and Authentication Consulting
Subdivision of Authentication Consulting
To provide consulting services as below:
1. CE certification consulting
2. Regulation and product registration to U.S.FDA(510K)
3. Quality management system certification consulting
4. GMP consulting of medical instrumentation
5. CCC compulsive product certification consulting
6. Quality management system optimizing consulting
7. Quality System Examination of medical instrumentation productive enterprises
8. Consulting on establishment of medical instrumentation productive enterprise
9. Consulting on establishment of medical instrumentation commercial enterprise
To provide extending services as below:
1. Seminars on quality management system
2. Specific training on quality management system
3. Basic training on requirements of quality management system
4. Internal checkup operation training on quality management system
5. Internal checkup of quality management system

Subdivision of Special Trainings
1) To provide regulation and standard training course
2) To provide special trainings on quality management system
3) To provide enterprise management and technical trainings
4) To provide various special trainings locally and internationally
5) To maintain and expand the “Internet Learning Platform”
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Technology and Regulation
The function of this department is to propagandize and implement the government policies, established regulations and standards, to open discussions about regulations and techniques, to collect opinions and suggestions from members and respond as well, to provide the professional technical services in medical device industry.
• To provide registration services on SFDA for all manufacturers
a. Compile and revise technical specifications
b. Provide technical supports of Sample testing
c. Submit documents to SFDA
• To provide services of clinical trials
a. Compile clinical plans and reports
b. Support doctors in clinical processes
• To help to export devices to other countries
Apply for export sales certificates on medical instrumentation on behalf of the customers.



中国医疗器械行业协会

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China Association for Medical Devices Industry