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Company Profile

Team advantage

Contact: 010-57253929
Website: www.bestivdmd.com
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About us

Beijing Best IVD MD technology Co. Ltd is your gateway to China In-vitro diagnostics and Medical Device market. It is a China based consultancy for regulatory affaires and clinical affaires of

National Medical Products Administration(NMPA). We have helped more than hundreds of IVD and medical device products to obtain registration certificate from the NMPA. We can help you find the good sales agent in China and bring the international manufacturer into contact with the Chinese sale firms.

Our services are

• Translation of product technical files

• Preparing Registration folder

• Planning and accomplishment of clinical trials in China

• Compiling the product technique standard

• Going through the type testing

• Submit to NMPA

• Follow-up the NMPA evaluation

• Sales market consultant

BJIVDMD is founded by a strong team of senior consultants and technicians, some of them having more than 10 years of register and clinical trial experiences. With dedication, experience, professionalism, and client-oriented mindset principle BJIVDMD provide the housekeeper type close services to the manufacturers and agents. Save your market time and improve your market competitiveness.

Team advantage

1. Wide co-operation clinical sites, covered many province in China, including Peking Union Medical College Hospital, Peking University People’s Hospital, Jilin Province People’s Hospital, Shengjing Hospital of China Medical University, Qilu Hospital of Shandong University, The Second Affiliated Hospital of Zhejiang University School of Medicine, Shanghai No. 6 People’s Hospital, Armed Police Hospital of Guangdong Province, The First Affiliated Hospital of Jiaotong University, Xinjiang CDC etc.

2. According to the product, select specialized hospital to make sure the speech of the positive sample selection or the enrollment of the patients. For Example, we will screen the infection hospital for the infectious testing, screen the Women and Children’s hospital for the neonatal and prenatal testing, screen the orthopaedics specialized hospital for the orthopaedics implants.

3. Rich clinical experience, For In-vitro diagnostic, such as infectious disease (including the blood screening products which being managed as drug), virus, biochemistry, tumor marker, hormone etc. Covered many testing type, including GICA, ELISA, CLIA, TRF, PCR, BC, ITM. For Medical Device including orthopaedics implants, therapeutic instrument, Diagnostic System.

4. Master NMPA laws and regulations, we have successfully performed more than one hundred products registration work at NMPA of In Vitro Diagnostic reagents(including class II and class III) and medical device (including class II and class III).

5. Successfully got the register approval of nearly hundrads of  medical device advertisements.

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Beijing Best IVD MD Technology Co., Ltd. www.bestivdmd.com
Addr: Room 218, No.29 Building.No.61 Fuxing Road, Beijing, (100036) P.R.China, tel:010-57253929 18601253261 email:bestivdmd@bestivdmd.com
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