Tags: | NMPA | Medical Device | Medical Device | 药监局 | 医疗器械 | 医疗器械 |

Some manufacturers want authorize distributors as their SFDA legal representative agent, since they think they can save legal representation agent fee, etc., by this way. However, this will bring you more risk.

1. SFDA legal representative agent must be proficient in SFDA registration regulations and professional technologies, while the focus of the distributor is not on that point. Provided that the distributor submitted unqualified technical data to SFDA, it might cause registration failure to your product, and cause a waste of time and money. What’s worse, SFDA might think that your providing fraud data and your facility will be listed in the restricted list; which means you are not allowed to register your product in a long time and lose the vast China market.

2. The duration of SFDA cosmetics approval license lasts for 4 years, which means the duration of the authorization of SFDA legal representative agent is the same. Since SFDA need the consent and assistance form your prior distributor, are you sure they will cooperate with you positively? Unless you will be sure to cooperate with your distributor for more than 4 years or it will be a lot of trouble if you want to change your distributor or SFDA legal representative agent.

3. To register your products you will be required to provide all of your technical documentation to the registration agent. Most companies prefer not to put confidential design information in the hands of a sales entity, since they sometimes also represents other competing companies.

4.What the distributor focus on is sales. Will they keep you updated on SFDA regulatory changes which are important to you?

5. If SFDA question about an incident or a non-compliance that involving your Products or your company, will your distributor defend his own company or yours?

6. Most distributors are not aware of the responsibilities of being an After Sales Agent and Legal Agent.

In view of these, it is an intellichoice to choose a third party company which has no business interests conflicts with you as your own SFDA legal representative agent.