1. Production license: Enterprises that produce health products need to obtain a production license issued by the US Food and Drug Administration (SFDA). License is the audit and approval of the production facilities, process flow and quality management system of an enterprise to ensure that the enterprise complies with relevant laws and standards.
2. Product registration certificate: Health products need to be registered with the US Food and Drug Administration to obtain a product registration certificate. Registration certificate is the approval of product formula, efficacy and safety. To ensure that products comply with relevant laws and standards.
3. Production standard certificate: the production of health care products needs to meet relevant production standards, such as "Quality Management Standard for Health Food Production". Enterprises need to obtain production standard certificates through relevant testing and evaluation to prove that their production processes meet the standard requirements.
4. Licensing of packaging labels: The packaging labels of health products need to comply with relevant national laws and standards. Enterprises need to obtain packaging label permission to ensure the accuracy and compliance of product packaging label content.
In addition, according to the regulatory requirements of different regions and countries, other licenses or certificates may be required. For example, some countries may require health care products enterprises to obtain GMP (Good Manufacturing Practices) certification to ensure that the production process meets international quality management standards.
The process of applying for a health care product production license includes the following steps: first, you need to prepare relevant materials, such as business license, product formula, production equipment, etc. Then, fill in the application form and submit it to the relevant departments, and pay the corresponding application fee. Next, relevant departments will conduct audits, including the inspection of enterprise qualifications, production environment and product quality. If approved, a health care product production license will be issued. Applicants are required to abide by the Regulations on the Management of Health Products Production and Operation and other relevant laws and regulations to ensure the quality and safety of products. In addition, the applicant should regularly supervise and inspect the production environment and product quality to ensure compliance with relevant requirements. To apply for a health care product production license, it is necessary to carefully prepare and cooperate with the audit work of relevant departments to ensure the compliance operation and the reliability of product quality.
Legal basis:
People's Republic of China (PRC) Food Safety Law;
Chapter IV Food Production and Sales
Section 2 Control of Production and Operation Process
Article 66 The use of preservatives, food additives such as preservatives and food-related products such as packaging materials in the packaging, preservation, storage and transportation of edible agricultural products entering the market shall conform to the national food safety standards.