Typically, Western medical device companies enter the China market in one of two ways.
The first and best way is to follow the lead of the Multinationals; create a legal entity in China, a Wholly Owned Foreign Entity (WOFE) is generally considered the most desirable structure. Obtain CFDA license to conduct desired business, including acting as the Legal Entity and After Sales Service Agent for the China market. Handle CFDA registrations internally or via a CFDA regulatory specialist. Control CFDA licenses. Select and closely manage the appropriate number of distributors to properly cover the vast and diverse market. Prevent use of sub-distributors to ensure accountability and traceability.
As small and medium size companies generally don’t have the resources to follow China best practices, they typically follow a traditional International market entry by selecting one distributor (or master distributor) to represent them in the market. There are a number of potential challenges with this path.
CMC offers an alternative. We are licensed by the CFDA to perform the functions on behalf of Western medical device companies, including Registration Agent, After Sales Service Agent and Legal Agent. We hold the licenses in our name on behalf of our clients. We preserve our client options to change their strategy in the market at any time. We essentially become an extension of our client’s team and act on their direction in the market with the goal of achieving best practices proven by the leading multi-national corporations (MNCs) at a fraction of the cost and risk.
Operational activities we have performed for clients include:
- Fulfillment of all China General Management functions
- Successful achievement of CFDA regulatory approval
- Agent of record with the China CFDA for After Sales 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