Special Medical Purpose Formula Food Registration System
2024-06-28 19:40:41
Special Medical Purpose Formula Food produced, sold, and imported within China must be registered with the Food Safety Supervision and Administration Department of the State Council.
Definition
Special Medical Purpose Formula Food refers to formula food specially processed and prepared to meet the special nutritional or dietary needs of people with restricted eating, digestive and absorption disorders, metabolic disorders, or specific disease states. It includes special medical purpose infant formula food suitable for children aged 0 to 12 months and special medical purpose formula food suitable for people aged 1 year and above.
Competent Department
State Administration for Market Regulation.
Application Subject
Production enterprises intending to produce and sell Special Medical Purpose Formula Food within China, as well as overseas production enterprises intending to export Special Medical Purpose Formula Food to China.
Work Flow
Documents List
1. Application for registration of Special Medical Purpose Formula Food purposes;
2. Product development report and product formula design and their basis;
3. Production process data;
4. Product standard requirements；
5. Product standards and sample manuals;
6. Test sample inspection report;
7. Proof materials of research and development, production, and inspection capabilities;
8. Other materials indicating product safety, nutritional adequacy, and clinical efficacy for special medical purposes;
9. *Clinical trial report.
Note: The marked "*" applies to the registration of Specific Full Nutrition Formula Food.
Our Services
1. Legal Advisory Services
(1) Legal and regulatory consultation on the Special Medical Purpose Formula Food Registration System；
(2) Customized consultation on registration strategies and training for Special Medical Purpose Formula Food；
(3) Assist clients in conducting relevant due diligence work；
(4) Intellectual property protection.
2. Product Compliance Services
(1) Risk assessment for registration；
(2) Registration application services；
(3) Post-registration compliance services for production and operation activities.
Definition
Special Medical Purpose Formula Food refers to formula food specially processed and prepared to meet the special nutritional or dietary needs of people with restricted eating, digestive and absorption disorders, metabolic disorders, or specific disease states. It includes special medical purpose infant formula food suitable for children aged 0 to 12 months and special medical purpose formula food suitable for people aged 1 year and above.
Competent Department
State Administration for Market Regulation.
Application Subject
Production enterprises intending to produce and sell Special Medical Purpose Formula Food within China, as well as overseas production enterprises intending to export Special Medical Purpose Formula Food to China.
Work Flow
Documents List
1. Application for registration of Special Medical Purpose Formula Food purposes;
2. Product development report and product formula design and their basis;
3. Production process data;
4. Product standard requirements；
5. Product standards and sample manuals;
6. Test sample inspection report;
7. Proof materials of research and development, production, and inspection capabilities;
8. Other materials indicating product safety, nutritional adequacy, and clinical efficacy for special medical purposes;
9. *Clinical trial report.
Note: The marked "*" applies to the registration of Specific Full Nutrition Formula Food.
Our Services
1. Legal Advisory Services
(1) Legal and regulatory consultation on the Special Medical Purpose Formula Food Registration System；
(2) Customized consultation on registration strategies and training for Special Medical Purpose Formula Food；
(3) Assist clients in conducting relevant due diligence work；
(4) Intellectual property protection.
2. Product Compliance Services
(1) Risk assessment for registration；
(2) Registration application services；
(3) Post-registration compliance services for production and operation activities.
