China has become the second largest medical device market in the world. Sustained economy, population growth and a burgeoning aging population makes China a lucrative market for foreign medical device and pharmaceutical manufacturers. Nevertheless, China is considered one of the most challenging markets to obtain market authorization. This is partly due to its complex and dynamic regulatory landscape and cultural and language barriers. CFDA’s focus in the last few years to support the domestic manufacturers is proving to be a disadvantage for foreign manufacturers and is evident by the dwindling number of registered foreign medical products.
We wanted to gain perspective on the CFDA registrations process with the CFDA. Who better to ask than the leading local experts themselves? With much demand, we interviewed two leading regulatory experts in China to obtain tips and tricks of registering medical products successfully with the CFDA. Here are answers to your top 5 questions:
1. What should foreign manufacturers AVOID when trying to register their products in China?
Fudiao:
Do not provide information based on technical requirements from other countries (FDA, CE Mark). The application must meet the Chinese national standards, therefore, follow the CFDA requirements.
Yanming:
All product information submitted to the authorities must be true and traceable; never submit false content.
2. How should clients approach registration with the CFDA?
Fudiao:
Prepare and submit the relevant supporting documents and technical information based on the provisions of the CFDA – Drug/Medical Device Registration.
Yanming:
Always keep an eye on the progress of the application.
- Connect with people working at the CFDA and get acquainted with each step of the application process.
- Maintain good and timely communication with the person responsible for reviewing and approving your application. If there is a problem in the registration process, try to solve it quickly before a written formal notice.
- Once the Technical Review is approved, get in touch with the person in charge and ensure the approval certificate is issued in a timely manner.
3. What is the most important tip you would give to foreign manufacturers?
Fudiao:
Here are four questions foreign manufacturers must ask themselves prior to initiating regulatory approval process in China.
- Does the product have approval from the country of origin?
- Which category does the product belong to in China? For example, medical device, drug, hygiene, combination, etc? What is the classification?
- Does the product meet the Chinese mandatory requirements? For medical devices, manufacturers must comply with both the national standards, Guobiao (GB) and the Industry Standards (YY). The GB standards are the Chinese national standards issued by the Standardization Administration of China (SAC) and the Chinese National Committee of the ISO and IEC. The YY standards define the scope, parameters and prescriptive limits for product test requirements of medical devices. This knowledge will help clients understand whether their product will require additional testing. Accordingly, they can account for added time and cost.
- Does the product have all the informationincluding test data required by the CFDA? A lack of understanding of the requirements can create issues during the approval process.
Yanming:
Ensure the data and documents are truthful and accurate. Do not try to bribe the official. Also, ensure you build a good relationship and open lines of communication with the appropriate government officials.
4. What has been your experience working with foreign manufacturers? Do they all have trouble obtaining product approval?
Fudiao:
There are still problems in the current CFDA system. Compared to the regulations in Europe, US, and Japan, CFDA is comparatively nascent. Many of the policies and regulations are written only in Chinese, which adds to the complexity for most foreign manufacturers. Moreover, foreign companies are used to a systematic registration process in their local market, which makes it harder for them to adapt to the paper-based operation system with the CFDA. Some regulations are vague and difficult to understand. With the new Supervision and Regulation of Medical Devices launched on June 1, 2014, foreign registrations have become even more difficult. In 2014, there were 4500 products registered by foreign manufacturers. In 2015 alone, the number of registered products for foreign manufacturers dropped down to 1100.
Yanming:
We have worked with clients from Asia (Korea, Japan , Russia, India), Europe (Italy, Sweden) and the US. Our experience has been that as long as the foreign manufacturer complies with all the local technical requirements, approval is granted.
5. How many months can it take for a foreign manufacturer to obtain approval in China?
Fudiao:
There are five scenarios for medical devices:
- Class I: 1-2 months
- Class II (without Clinical Trial): 8-12 months
- Class II (with Clinical Trial): 12-24 months
- Class III (without Clinical Trial): 10-14 months
- Class III (with Clinical Trial): 16-36 months
Medical device classification is the foundation of the registration requirements and process. All class III and imported devices are managed directly by the central CFDA.
Yanming:
There is not much of a time regulation. The process is complicated and involves different factors (local government, CFDA departments, etc.). Therefore, the timing often differs from company to company. It is best to have the manufacturing facility in ‘economic’ and ‘technology’ developed zones in China because this makes the approval process easier.
A little about the experts:
Fudiao S.
Fudiao is an experienced regulatory affairs professional with over 10 years experience in the medical device industry. He has worked for many Fortune 500 companies both in China and abroad.
Yanming W.
Yanming is a Chinese Expert with over 10 years regulatory experience in the pharmaceutical industry. He is currently Regulatory Affairs Manager at a pharmaceutical company in China.
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