PROFESSINAL CONSULTANTS ON MEDICAL DEVICE

Osmunda Medical Device Consulting Organization
1?Brief Introduction
Osmunda Medical Device Consulting Organization (Guangzhou, Beijing, Shanghai, Suzhou, Shenzhen and Jinan) is the largest and most professional consulting company in the field of medical device in China. All Osmunda Consultant team members are from sizeable medical devices enterprises, well-known notified bodies and testing organizations. We are well versed in global various medical device quality system certification and product registration, such as SFDA registration, QSR 820 system, FDA registration, ISO 13485 system, CE certification etc. Our service includes clean room design, clinical trail, third party audit, training of regulations and standards, etc.
Our headquarters is in Guangzhou, and we have five branch offices (Beijing, Shanghai, Suzhou, Shenzhen, and Jinan) which could provide high-speed local services and communication. By far, Osmunda has successfully assisted nearly 1,200 domestic and foreign enterprises in achieving various medical devices registration and certification. We will be your trustful partner and your most professional guide.

2?SFDA Registration
Based on the potential risks and intended use, medical devices are divided into three management categories by SFDA of China (State Food and Drug Administration). All medical devices need to be registered according to Medical Device Registration Administration in order to be sold and used in China.
Different countries have different regulations about medical devices, relying on the deep understanding of various regulations and abundant practical experience, Osmunda could help your products be easily approved by SFDA and be widely applied into the Chinese market.

3?SFDA IVDD Registration
Currently in China, except the in vitro diagnostic reagents (IVDD) used for blood screening and radioisotope labeling, other IVDD may be managed as medical device (MD). IVDD is divided into three management categories according to its risk level. There are some special requirements during the IVDD registration in addition to the general regulations of medical device.
During the SFDA registration, the class 2 and class 3 of IVDD are required to conduct clinical trial in China. Osmunda has rich clinical resource and experience and would provide you with best comprehensive services.

4. Clinical Trial Service in China
As for the imported medical devices needed clinical trial in China, Osmunda could assist enterprises in medical institute choosing, clinical program preparing, clinical trial following-up, statistic analysis conducting and final clinical trial report obtaining. According to relevant requirements, at least two hospitals should be chosen for the clinical trial. Osmunda has helped enterprises to conduct the clinical trial in several dozens of clinical trial institutions (hospitals) in several cities.

5.Factory Inspection Service in China
Osmunda could provide second/third party audit and exported inspection to medical device suppliers in China for foreign clients or buyers, to ensure the supplied products meet the contract requirements and other special requirements of buyers, and the certified products meet national certification standard and be consistent with prototype sample in stipulated extend.

6. Medical Device Professional Translation Service
Professional translation of medical device, compared with general translation, needs higher requirements for translators. Osmunda has an excellent translation team with professional knowledge of medical device, rich industry experience and excellent bilingual translation to help you clear the language barriers when your products are introduced into Chinese market.

7. Quality System Inspection Service in China
We help the suppliers and Original Equipment Manufactures (OEM) of foreign medical device enterprises in China to establish the Quality Management System meeting different national requirements, such as: FDA 21 CFR 820, ISO 13485, B-GMP, etc., and to continuously standardize and improve the operation and successfully pass the inspection of foreign clients or authorities.

8. Chinese Agent Service
According to the SFDA registration of imported medical device, if not owning any branches in China, the foreign enterprises are required to designate an independent legal entity in China as their agent and after-sale service agency. Osmunda (Guangzhou, Beijing, Shanghai, Suzhou, Shenzhen, and Jinan) is designated as an agent and after-sale agency, who would directly and effectively communicate with the SFDA, deliver regulatory information to foreign enterprises, resolve relevant problems and provide regulatory supports for their Chinese market development.

9. Medical Device Investment Service in China
As the leading information supplier of medical device industry in China, we have an insight into industry development, deeply understanding of client’s challenges and needs. Chinese market is full of unlimited opportunities for global medical device enterprises. Osmunda would help you develop a complete market analysis and investment strategy of Chinese medical device, including the analysis of product, price, market opportunity, sales channel, industry competition, product inventory, trade data, personnel supply, etc., to master the latest investment hot spot and opportunity in Chinese medical device industry.

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