CFDA approval process
CMC is licensed by the China Food and Drug Administration (CFDA) as a registration agent, after sales service agent, and legal agent for foreign medical device companies. Our team has completed hundreds of class III and class II medical registrations on behalf of US and European medical device companies.
All foreign medical devices must register at the national level in Beijing. Over the past several years, the CFDA has improved the oversight and regulation of the device registration process. Contrary to popular belief, there is no way to fast-track the registration process. There is, however, the opportunity to make mistakes and slow or otherwise delay the registration process. As such, it is imperative to stay in close contact with the test center and CFDA inspectors throughout the process to ensure things progress as efficiently as possible.
It is also 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 center and CFDA investigator in advance of the process. By doing so, we help ensure the most timely regulatory approval.
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 after sales 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. The alternative is to have a distributor, or master-distributor, perform this function for you. Realize that if you are not satisfied with performance or want to change your operational plans in the market, your distributor partner must sign and officially stamp documentation giving up their responsibilities. If they choose not to support you, you cannot make a change, regardless of any legal agreements or distribution contracts that you may have executed.
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.
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 strategy
As the regulatory process generally takes a minimum of 14 months, and more likely 18 or more months, you will have sufficient time to develop your go-to-market strategy while the regulatory action is in process. China is one country, but it often looks and feels like a lot of countries. There are 34 different provinces, each province larger than most independent countries, and while you wouldn't need to enter all 34, you will want to target more than a few.
Medical device distribution is highly fragmented in China. Generally, distributors are quite small with very few direct hospitals to which they sell. The best practices employed by the large multinationals in China include the direct management and supervision of dozens or hundreds of first level distributors to get the desired market coverage. Although our clients don't need dozens or more distributors to start, it is wise to consider more than a few.
We help to develop go-to-market strategies based upon unique products and goals for the China market. Additionally, we help facilitate strategic partner identification and qualification if that is part of your desired approach to the China market.