7.FAQ on SFDA Registration:

 

1. Who is the SFDA certificate issued to?

Different from other countries, which issue registration to the local dealers, SFDA issues the registration certificate to the manufacturers. The applicant of the registration can be the manufacturer's dealer or consultants, but the true owner of the certificate is still the manufacturer.
 

2. I am a manufacturer. Can I apply for this registration myself?

Yes, you can. In theory, any one can apply for registration. However, those who did it once would tell you it is not that simple. First of all, SFDA updates its regulations frequently and published the changes on its websites in Chinese. Second, SFDA requires Product standard to be filed, which has to reference Chinese national standards. There is no detailed guideline on how to prepare Product Standards at the present time. Each company must research for equivalent standards in China before preparing for their document. Thirdly, companies with Class II and III products need to locate testing centers for type testing or clinical trial sites to perform clinical trials. There are a lot of coordination, negotiation and management involved to get those tasks done. The above tasks must be completed before a formal registration application can be submitted. Even after the application is submitted, the applicant still needs to monitor the progress and intervenes when needed to move the document around the departments. In short, it is not impossible, but unadvisable to register if you have not done it before. Whitney Consulting started to register products since 1998. It is the company you can trust and rely on for quality work and peace of mind.
 
3. How is my product categorized based by SFDA?

SFDA's classification rules are similar to USFDA's. The detailed product list can be found at www.sfda.gov.cn/class . If you cannot find your product on this list, you can request SFDA to make a determination by submitting supporting documents. Whitney can also consult with SFDA on your behalf.

 
4. What documents are required to file?

All documents submitted must be in both Chinese and English. Documents that are needed for registration can be grouped into three categories:

 

  • Manufacturer's eligibility by the home country: this means the company's business license issued by the government, permissions by the healthcare and medical device regulatory agencies, etc.
  • Product information: product standard, user's manual, permission to market from the home country's government agencies.
  • Third party verifications - Type testing report or clinical trial report: SFDA request additional validation of the products by its authorized testing centers in China . Class II products need to have type testing reports issued by authorized testing centers. Class III products may need clinical trial reports. There are authorized hospitals who can perform clinical trials as well.

ecause SFDA constantly modifies its regulations, it is advisable to contact Whitney Consulting for more details. Lack of document or mistakes in document will only delay the process. Whitney emphasize on ˇ°doing it right the first timeˇ±.

 
5. I have just started in the Chinese market. I have not found a company to do my after-sale service, which is required at SFDA registration. What can I do?
If you have not worked out the service agent at the time of registration, Whitney is willing to undertake this task temporarily. Whitney's Chinese company ¨C Weini Huili Medical Equipment Company ¨C is a legally registered business, authorized to distribute and service medical products. We have engineers and a service center in Beijing . We will act as your after-sale service center until you sign up a service agent. At that time, we will file an amendment to change the service agent with SFDA. Whitney's Chinese company can also take care of other administrative matters (such as A/R, A/P, contacts, etc,) for the clients temporarily until the client sets up its own base in China .
 
6.How long does it take to register a product with SFDA?
Based on SFDA regulation, the entire process should take about 4 months from the time the submission package is sent in IF everything goes smoothly and no problem in the documentation. However, there are many reasons that can delay the process, such as missing documentation or explanations, questions from the reviewing experts, or absence of a key person in SFDA who needs to sign off the document at a certain step. Typical time frame for each registration has been 6-8 months. Adding the extra time spent on product standard, type testing, etc., a Class II product can takes about 10 months or more to complete. Whitney has the ability to control the process from start to finish by relying on its knowledge and past experience with SFDA, each agencies and testing centers.
 
7. What is so special about Whitney?

Think for the client! This principle is not about one's ability, but about his willingness. We, at Whitney Consulting, make it as our responsibility to find the best solution for our clients. We are always keenly aware of our client's needs and their corporate objectives. We focus on project management and do our best to maintain the project schedule. Whitney Consulting especially welcome the opportunity to explore new grounds within SFDA rules, to challenge the existing, ˇ°normal wayˇ± of doing business in China . Our experienced consultants can get through any obstacles and make things happen. If you have a situation that does not fit in the ˇ°normˇ±, contact the Whitney's and let them find a way to resolve your issues. We believe in our abilities to break new grounds and be successful in this market.

 
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