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Since 2018, the NMPA (National Medical Products Administration) shares with the CFDA (China Food and Drugs Administration) the regulatory control and registration of food products, drugs, medical devices and cosmetics. All products exported to China or manufactured in the domestic market are affected.
The NMPA and CFDA headquarters are located in Beijing. This article presents their respective areas of monitoring as well as up-to-date regulation and requirements.
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Publication updated on January, 2, 2023 |
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1. Presentation and organization of CFDA and NMPA in China
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In 2013, the SFDA (State Food and Drugs Administration) is renamed CFDA (China Food and Drugs Administration). It is the authority in charge of the safety and surveillance of 4 main families of products : food products, drugs & pharmaceuticals, medical devices and cosmetics.
- Since 2018, a reform of the administrations has led to the following reorganization :
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The NMPA replaces the CFDA as the supervisory authority for 3 product families : medical devices, drugs + pharmaceuticals and cosmetics. |
It is a separate entity under the direct supervision of the SAMR (State Administration for Market Regulation). NMPA has 11 departments in charge of products approval, inspections and regulation development. It supervises 31 provincial offices in charge of regional affairs. The Shanghai office is called SMPA (Shanghai Medical Products Administration).
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The CFDA keeps its prerogatives of monitoring and supervising the hygiene of food and drink products. It remains under the integrated control of the SAMR. |
2. The function and responsibilities of NMPA
a. Functions at national level and areas of monitoring
- Elaborate and develop laws + regulations in the medical and pharmaceutical sectors
- Issuing approvals & related licenses and certificates for companies, products and individuals
- Supervise companies, qualified individuals and products
- Organize controls, inspections and take actions aganst the serious infringements.
b. The role of NMPA in enforcing market control
3. Responsibilities of the China Food & Drug Administration (CFDA)
The CFDA is now under control of the SAMR. The latter directly controls all matters related to food product safety : regulations, surveillance, inspections, controls, licenses and permits.
Attention for food producers and exporters
Your company is based outside China, you already sell or want to export to sell in China. The China Customs now require your products to be pre-registered on one of their online platform. On April 12, 2021, the Chinese customs administration (GACC) issued 2 decrees coming in force from January 1, 2022 onwards.
Decree 248 is the "Regulation on the registration and administration of foreign producers of food imported to China." It stipulates that food processing centers and warehouses exporting to China have to register with Chinese Customs. This decree divides food products into 2 categories :
The 1st category concerns food products classified as "high risk". For them, a registration procedure applies, in a logic of approval. It includes seafood, meat, dairy products, cereals, honey, eggs, pasta, nuts and beans, fresh and dried vegetables, dried fruits, tobacco, dietetic and health products. Manufacturing or processing companies have first to be inspected by the health authorities in the country of origin. The latter then recommend the company to the GACC and its products can be registered on the Chinese customs platform. For French companies already exporting food to China, there is little risk. These additional procedures and formalities demonstrate the Chinese authorities' wish to involve manufacturers, exporters and their governments in a global chain of responsibility for safety.
The 2nd category is reserved for "low risk" food products and wines & spirits. For them, only a declarative logic prevails with a registration only. Manufacturers, processing centers and exporters can register directly with customs. No prior inspection nor approval are needed. The registration formalities can be filled on the dedicated online platform of Chinese Customs. Foreign exporters can get help from their importing agent if relevant.
For example, article 15 of this decree indicates the GACC registration number of food producers must be shown on the packaging's chinese back labels.
Decree 249 concerns the “administrative measures on food security import and export”. It regulates the requirements related to the export of food products to China. It explains the registration process, the traceability of Quality archives by both the importers and the exporters. Finally, it gives some information about quarantine measures, inspection and mandatory labeling.
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4. Hygiene, licenses, food and sanitary permits in China
The Chinese health and medical authorities stipulate operators in certain sensitive sectors must get additional licenses or special permits before they can sell their products.
5. Our services for food, health and medical devices in China
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