FDA and NMPA registration in China

CFDA and NMPA : food, health and medical authorities in China

By C.i. Process (Shanghai)
 
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CFDA and NMPA registration in China

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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China FDA and NMPA regulations
 
  Publication updated on october, 10, 2022      
 
Home > regulations and news > The Chinese administrations in charge of food and health products safety
 


1. Presentation and organization of CFDA and NMPA in China

  • 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 :


    China NMPA administration
     
    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).

     

    CFDA China Food and Drug Administration
     
    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

  • The supervisory attributes of NMPA are applicable to all China registered companies that import, distribute or manufacture the following products :

    • Pharmaceuticals
    • Cosmetics
    • Medical devices and apparatus

    Its supervision power reaches all types of companies : domestic invested companies, fully foreign invested companies or subsidiaries (WOFE) and Sino-foreign joint ventures.


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.

 

 

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.

  • Please see hereunder some quite representative, but not exhaustive examples

    Food products : 4 main types of approvals (by FDA / SAMR)

    1.

    Food product license. For all food operators, including beverages (for restaurant service)

    2.

    Food production permit (production license also called "SC" license )

    3.

    Certificate of registration of milk powder ingredients for children

    4.

    Registration for manufacturing or importation of health products



    Cosmetics products : 4 main types of approvals (by NMPA)

    1.

    Import license for "special purpose" cosmetic products

    2.

    Import license for "ordinary" (non-specific) cosmetic products

    3.

    License to produce cosmetic products in China

    4.

    Approval of new raw materials for cosmetic products


    Note to the attention of foreign producers and exporters of cosmetics


    For this Chinese market that has become strategic, there is, since 2018, a standards program that applies to cosmetics distributed in China. Since 2021, there is also a new Chinese regulation for cosmetic products imported or produced in China. It is called CSAR (Cosmetics Supervision and Administration Regulation).

    The requirements for registration and labeling are frequently updated. Its latest measures came into effect on May 1, 2021. One of the requirements is that exporters have an increased responsibility in the overall safety chain. For example, those responsible for foreign production sites must be named.

    The demanding CSAR regulations also list the components that are allowed. The requirements for approval and marketing authorization differ according to the specific or ordinary purpose of the products. There are separate requirements for medical devices. The authorities ensure that their distributors have complete and up-to-date licenses and authorizations. In 2020, the French Federation of Beauty Products Companies estimated that, with a turnover of almost 16 billion EUR, China has become the first export market for French cosmetics.







    Medical devices and apparatus : 5 main types of approvals (by NMPA)

    1.

    Licensing and registration of medical devices manufactured in China

    2.

    Licensing and registration of imported medical devices

    3.

    Approval of clinical tests for high-risk medical devices (class 3)

    4.

    Import registration of low-risk medical devices (class 1)

    5.

    Registration of clinical test facilities on medical devices.



    Pharmaceuticals : 12 main types of approvals (by NMPA)

    1.

    Approval of import or distribution of vaccine products

    2.

    Approval of import of narcotics and psychotropic drugs

    3.

    Registration of imported pharmaceutical products

    3.

    Approval of operators or manufacturers of radiopharmaceuticals

     

    the above lists are just a few non-exhaustive examples.


5. Our services for food, health and medical devices in China



 


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