Service Schemes for Medical Device Export to
the European Market
If the food is sold in China, the service schemes we can provide include:
1. Domestic food production license
2. HACCP certification
3. ISO22000 certification
1. Domestic food production license
Whoever engaged in food production activities within the territory of the People’s Republic of China shall obtain a food production license according to the law.
The principle is “one food production license for one enterprise”, that is, each food producer engaged in food production activities shall obtain a food production license. The food and drug administration department shall implement classified licensing for food production according to the risk level of the food.
The China Food and Drug Administration shall be responsible for supervising and directing the administration of food production licensing in the country. The local food and drug administration department above the county level shall be responsible for the administration of food production licensing in the corresponding administrative region.
The food and drug administration departments of provinces, autonomous regions, and municipalities directly under the Central Government may determine the administration authority for food production licensing of the food and drug administration departments at the municipal and county levels according to the food category and food safety risk. The food and drug administration departments of provinces, autonomous regions, and municipalities directly under the Central Government are responsible for the production licensing of health food, formula food for special medical purposes, and formula food intended to infants.
Details can be found in the Measures for the Administration of Food Production Licensing (SAMR Order No. 24 on January 2, 2020).
2. HACCP certification
Generally, enterprises involved in food export will be recommended to establish a HACCP system and pass the certification.
HACCP is the abbreviation of Hazard Analysis Critical Control Point, which means the critical control point of hazard analysis.
As a systematic method, HACCP is the basis for ensuring food safety in the modern world, and its role is to prevent the generation of hazardous substances in the food production process (including manufacturing, storage, transportation, and sales). Rather than relying on the testing of final products to ensure food safety, HACCP bases food safety on the control over processing to prevent perceived hazards in food products or to reduce them to an acceptable level. Due to the internationalization and globalization of trade, the development of an international standard based on HACCP principle has also become a strong demand of the food industry in all countries.
Benefits of the certification
a. Improve the internal process
b. Maintain the system operation through periodic audits to prevent system crash
c. Through the implementation of relevant laws and regulations, improve the reputation and avoid the certified enterprises from violating relevant laws and regulations
d. Use the certification as the basis of the company’s dedication, reducing the tendency to debts
e. Increase the export and market access opportunities when the market regards the certification as an access condition
f. Improve the consumer confidence
g. Reduce the frequency of customer audits
h. Have greater competitive advantage compared with non-certified enterprises
i. Improve the company image
The food and drug administration departments of provinces, autonomous regions, and municipalities directly under the Central Government are responsible for the production licensing of formula food intended to infants and young children.
Details can be found in the Measures for the Administration of Food Production Licensing (SAMR Order No. 24 on January 2, 2020).
3. ISO22000 certification
ISO22000 is applicable to all organizations throughout the food supply chain, including feed processing, primary product processing, food manufacturing, transportation and storage, as well as retailers and catering industry.
In addition, other organizations closely related to food production may also adopt this standard, such as the organizations producing food equipment, food packaging materials, food cleaners, food additives and other food ingredients.
Quotation Scheme for Medical Device
Export to the European Market
1. Quotation principle for domestic food production license:
The quotation for handling the food production license is based on the scope of enterprise declaration and the on-site basic conditions, and is usually subject to the number of person-days. The factors that determine the number of person-days include:
1) Place where the enterprise is located;
2) Scope of license activities declared by the enterprise;
3) Foundation that the enterprise already has, including hardware and software.
2. Quotation principle for HACCP certification
The quotation for the food HACCP certification is based on the scope of enterprise declaration and the scale of enterprise, and is usually subject to the number of person-days. The factors that determine the number of person-days include:
1) Number of employees;
2) Scope of HACCP activities declared by the enterprise;
3) Plant area and conditions of equipment and facilities of the enterprise.
3. Quotation principle for ISO22000 certification
The quotation for the food HACCP certification is based on the scope of enterprise declaration and the scale of enterprise, and is usually subject to the number of person-days. The factors that determine the number of person-days include:
1) Number of employees;
2) Scope of HACCP activities declared by the enterprise;
3) Plant area and conditions of equipment and facilities of the enterprise.
