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The NMPA (National Medical Products Administration) is located in Beijing. This governmental authority is the national headquarter and control center for all the regional offices of NMPA all over China.
Since 2018, the NMPA replaces the CFDA (China Food and Drugs Administration). Until then, it was in charge of the safety and hygiene monitoring of all food products, drugs, medical devices and cosmetic products. Here are their prerogatives.
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Publication updated on January, 4, 2022 |
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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, medical devices and cosmetics.
- Since 2018:
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The NMPA replaces the CFDA as the supervisory authority for 3 product families: medical devices, 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).
- The CFDA keeps its prerogatives of monitoring and supervising the hygiene of food products. It remains under the integrated control of the SAMR.
2. The function and monitoring power of NMPA in China
a. National functions and responsibilities of NMPA at national level
- 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 (FDA)
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 Registration and Administration of Foreign Producers of Food Imported to China." It stipulated that food processing centers and warehouses that export to China must 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 must first 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 on health and medical hygiene matters in China
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Regulatory analysis and preparation of approval files for import and distribution. Food, medical, pharmaceutical, dangerous or specifically regulated products according to the hygiene rules enacted by the CFDA and NMPA sanitary and medical authorities.
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Market research, competition and positioning surveys.
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Preparation of the product compliance in the context of a search for a search for a China distributor agent.
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Drafting of feasibility files for foreign investments. Comparison of investment conditions in cities and districts.
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Negotiation and assistance during denunciations or disputes with Chinese administrations.
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Legal registration of foreign owned companies in China. Obtaining the licenses, certificates and permits required to operate the targeted activities.
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Implementation of logistics and warehousing solutions. Storage and distribution for dry, temperature-controlled, regulated, hazardous, etc.
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Regulatory monitoring on China regulations for food & drugs matters, product registration and licensing.
- Advice and preparation of import files. Qualification of factories or production centers for sensitive products: foodstuffs, health products, hygiene, beauty and medical equipment.
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