CFDA Approval Process

CMC is licensed by the National Medical Products Administration (NMPA) to perform the roles of Legal Agent, Service Agent, and Registration Agent for foreign medical device companies. Our NMPA license includes all class I, II and III medical devices as well as diagnostics and reagents. Our scope of business also includes online sales of medical devices.

All foreign medical devices must register at the National Level in Beijing, whereas domestic Chinese medical devices register class I and class II devices at the Provincial Level. Over the past several years, the NMPA has improved the oversight and regulation of the device registration process and changes within the organization are ongoing.

It is important to assess the possible regulatory pathways and spend time prior to starting the process to avoid complications. We generally conduct an initial regulatory assessment and have direct contact with the appropriate test centers and NMPA investigators in advance of the process. By doing so, we help ensure the timeliest regulatory approval.

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We conduct an initial regulatory assessment and keep direct contact with test centers and NMPA investigators.

Control of CFDA Certificates

One of the most important things you can do prior to entering the China market is to either create your own legal structure in China, usually as a Wholly Owned Foreign Entity (WOFE) or to identify a non-distributor partner in the market to represent you as both your Service Agent and Legal Agent. This selection must be made at the beginning of the registration process.

By taking this one single action, you will preserve your options to change your strategy in the China market, if needed. As a non-distributor representative of foreign medical device companies, we perform this function on behalf of our clients

As a result, our clients preserve their ability to change strategy in the China market at any time. Whether you create your own legal structure in China or leverage our legal structure, we believe this is one of the highest value actions you can take.

Market Assessment

In addition to conducting a regulatory assessment, we feel it is also important to conduct a market assessment to better understand the real opportunity in China. Depending on your product, price point, and competitive differentiation, China may or may not be a worthwhile opportunity given the time and costs to enter the market.

We find that everyone has a different appetite for the depth of market assessment and research. While market research isn't our core business, we frequently find the need to perform this function on behalf of our clients and are confident we can obtain the right information to enable you to make well-informed decisions.


Go-To-Market Strategies

As the regulatory process generally takes a meaningful length of time to complete, you will have sufficient time to develop your go-to-market strategy while the regulatory action is in process.

We help to develop go-to-market strategies based upon unique products and goals for the China market as well as the constantly changing landscape, regulatory guidelines, and government initiatives. Additionally, we help facilitate strategic partner identification and qualification as well as logistic provider selection as needed.

Operational Activities we've performed for clients:

  • Fulfillment of all China General Management functions
  • Successful achievement of NMPA regulatory approval
  • Agent of record with the NMPA to perform role of Service Agent and Legal Agent
  • Development and execution of go-to-market strategies
  • Leverage network of proven and trusted distributors to support commercialization strategy
  • Assist with pricing assessments and bid/tender procedures
  • Clinical training, sales and marketing support
  • Market assessments and competitive intelligence research
  • Active on-the-ground problem solving for challenges that will inevitably present

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China Med Connect supports Western medical device companies with their operations and interests in mainland China.

Contact Us Today

China Med Connect supports Western medical device companies with their operations and interests in mainland China.

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