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PHYSIOMED CHINA PROFILE-Chinese FDA-Local Assembly


 

1.PHYSIOMED ELEKTROMEDIZIN AG


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PHYSIOMED ELEKTROMEDIZIN AG is a German enterprise dedicated to the manufacturing of professional level biomechanics, rehabilitation, and sports science equipment. It is a member of the GHA (German Health Alliance) along with Siemens, Braun, Leica, and Dräger.


In 2023, PhysioMED ELEKTROMEDIZIN AG, a German medical electronics company, merged and restructured with ERGOFIT and Proxomed Medizintechnik GmbH, further expanding its leadership position in the medical rehabilitation and sports science markets.

For over 50 years since its establishment, it has become a well-known brand with its high quality. Classic and innovative products have maintained a strong market position in the German market and exported to more than 100 countries around the world.

2.Physiomed Elektromedizin AG. Beijing Rep. Office


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Physiomed Elektromedizin AG. Beijing Rep. Office was established 

in 2004, located in the Physiomed Building, Tongzhou District, Beijing. The building has a sports biomechanics laboratory and a physical therapy showroom and has entered the stage of scientific research and use.




Physiomed Elektromedizin AG. Beijing Rep. Office, focusing on biomechanics, rehabilitation and sports science market development. In the past 20 years, we have a good sales network and many well-known users in the Chinese market.

Physiomed China can provide PET project service plans in the fields of rehabilitation, physical Training and medical care, that is, provide: Planning, Equipment, training and exchange services.

In addition to providing German high-tech equipment, based on years of accumulation, Physiomed China can provide corresponding rehabilitation centers, biomechanics, physical training, planning and design of medical and nursing institutions and personnel training.

3.Background of "localization" of medical devices:

With the Chinese government's requirements for "localization" of medical devices, many foreign medical companies have realized localized production in China, and have been recognized by the Chinese government, and have been identified as domestic products, which belong to local manufacturing.

In this context, major European and American medical device manufacturers have increased their investment in China, through sole proprietorship or joint ventures, to set up production enterprises in China. And in the name of the manufacturer, apply for the registration certificate of domestic medical devices of the China Food and Drug Administration.

The most typical is the large enterprises of radiation equipment, such as GPS, these three giants of radiation medical equipment, have opened factories in China to achieve the localization of main products in the Chinese market.

Konica's musculoskeletal ultrasound diagnostic instrument has obtained two domestic registration certificates in China.

The CPM of KINETECH, a French company in the rehabilitation medical industry, has also achieved a shell change and obtained a domestic medical device registration certificate in Zhejiang Province, China

At present, these related products are also winning bids in many government procurement.

In the future, foreign companies can set up production bases in China, reduce production costs and improve competitiveness through localized procurement, and can also participate in the international cycle in the future, and can export whole machines or accessories to other countries.Joint-venture brands such as Tesla, Buick, Volvo and Fiat, which are currently produced in China, account for a major share of China's auto exports. Not to mention the famous mobile phone brand Apple. Its production is all done in China.

4.Tianjin Physiomed "localization" production is about to land:

In order to keep pace with The Times, we also actively responded to the Chinese government's call for "localization", and established Tianjin Physiomed Technology Co., Ltd. in 2021. In 2023, we purchased a 2,000 square meter factory located in Jindi Weixin Yongtai - Xiqing Wisdom Garden, Xiqing District, Tianjin.


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We sincerely invite you to cooperate with us, our cooperation model is mainly as following:

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Part A: CKD cooperation mode:

Physioman Tianjin imported the corresponding sets of parts, assembled them in accordance with CKD(Completely Knock Down) mode, and applied for local medical device registration license in Tianjin, China.

Part B: SKD Cooperation Mode:

Physioman Tianjin imported the corresponding semi-finished products and accessories, assembled them according to SKD(Semi Knock Down) mode, and applied for local medical device registration license in Tianjin, China.

The Advantages:

a: The foreign party does not need to invest in the early stage and bear the cost of capital, site, personnel, and specific work in management.

b: Both parties do not need to invest a lot of time, manpower, material and financial resources in the establishment and management of the joint venture company.

c: The project cooperation can be started quickly, and the goal is to obtain the domestic registration certificate of Tianjin Drug Administration within two years.

d. Local procurement of products can reduce the production cost and labor cost of the original factory, and as a member of the original supply chain, you can sell back to the original factory. 

Local procurement of supporting products can be considered in the initial stage:

1. Such as computers, printers, carts, etc. can be purchased locally.

2. Large volume products: For some large volume, low cost products, such as machinery, electronic products, can be purchased locally.

3. Other products with relatively low manufacturing costs in China.