Regulatory executives from medical device companies often ask me about the best regulatory strategy for an Asian country and the timing to obtain registration approval. Before getting too far into the conversation, the first question I have for these RA executives is whether their company has done any market research to determine the demand for their product in the Asian country of interest prior to pursuing product registration. Of course, if there is no market opportunity in their target Asian country, there is no reason for an RA executive to spend time collecting documents, submitting a dossier, and doing local testing or clinical trials.
Quite frequently these RA executives say that the decision to enter a specific Asian market came from the international sales and marketing executive at their company, and the RA executive is not able to question the rationale for that decision. However, it is very important that regulatory executives question their sales and marketing team about the potential market for their products before starting the registration process. Over the years, I have seen many medical device companies spend a great deal of time, money and effort to register their products successfully, only to learn too late that there was no market opportunity for their products in that specific Asian country.
Since each country in Asia has its own unique medical system, particular reimbursement practices, and different ethnicities and religions that affect how people view certain medical products, it is necessary to conduct primary market research to make sure that product registration makes sense. In addition, proper market research is essential, given the fact that registering a Class II, III, or IV product in Asia is becoming more complicated, expensive and time consuming.
For example, registering a Class II product in China can cost approximately $40,000 in service fees, while registering a Class III product can cost $65,000 or more. These figures include local testing and translation, but not clinical studies. Local clinical trials in China can run from $150,000 to $750,000 depending on the specific product and the cost of the local clinical studies. These registration service fees do not include the recently increased CFDA government fees, which were introduced for the first time by the new Chinese regulations, which must be paid at the time of submission. In China today, government fees are about $34,000 for a Class II product registration and about $49,000 for a Class III product registration.
The timeframe to register Class II and III products in China is now 24–36 months if local clinical trials are not required. If clinical trials are required, the timeframe is prolonged for an additional year.
Given all of these factors, there is no getting around the fact that primary market research must be conducted in each Asian market of interest to determine the demand for every product prior to registration. Just because the medical device is the “best thing since sliced bread” in the United States or Europe does not guarantee that there is a demand for that product in a specific Asian market. Conducting accurate on-the-ground market research in each Asian country is the best way to ascertain the demand, market size and potential growth rates for your product, and is a key factor in your company’s success in Asia.