The National Medical Products Administration (NMPA )(国家药品监督管理局) (formerly the China Food and Drug Administration, or CFDA) handles:
Although Asia faces significant regulatory and operational risks, it is the fastest-growing market in the world. China is the most potential medical device market with $524 billion in sales by 2020. It is a promoter of great expansion, relying on its R&D and innovation capacity.
1. The product should be classified as a medical device in China;
2. The medical device has been approved for sale and registred in the original country;
3. The applicant should have its representative office in China or designate a corporate legal person in China as its agent to cooperate relevant activities. Natural persons cannot apply for product registration as an agent, and the agent must be an enterprise legal person.
With the popularization of disease prevention concepts, the increase of the elderly population and the importance of personal health, the consumption capacity of health food is steadily increasing in China.
According to statistics, the annual growth rate of China’s dietary supplement industry is about 10-15%. The market size in 2021 exceeded $34 trillion, this is mainly for special products such as functional supplements (QS/SC) and special medical purpose supplements.
Functional supplement refers to a health product with functions of skin care, immune system strengthening, and improvement of symptoms of a specific disease, etc. Depending on the type of food supplement, the period of the registration process varies from one to two years.
Nutritional supplement refers to a product designed to provide extra vitamins and minerals. Its role is to supplement the lack of food intake, to prevent nutritional deficiencies and to reduce the risk of certain chronic degenerative diseases.
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