Service Schemes for Medical Device Export to

 the European Market

If you are a food manufacturer, and you want to enter the U.S. market, we provide you with the following service schemes:

1. FDA food establishment registration

2. FDA FCE-SID food registration

3. FDA food pre-audit

4. FDA food factory inspection

5. FDA food label audit

1. FDA food establishment registration

In order to implement certain provisions of the Bioterrorism Act, the U.S. FDA has formulated the following requirements:

1) FDA food establishment registration;

2) Prior notice (PN) to the FDA when the food is to be shipped to the U.S.

This regulation came into force on December 12, 2003.

The enterprises referred to herein include: food enterprises engaged in production, processing, packaging or storage.

FDA food establishment registration is updated every other year, generally in the fourth quarter of even-numbered years.

Chinese food exporters, which do not register with the U.S. FDA due to lacking of relevant knowledge, will suffer from great economic losses. Therefore, companies intending to export food to the U.S. must register with the FDA and obtain the 11-digit registration number as early as possible.

2. FCE-SID food registration

In the early 1970s in the U.S., life-threatening botulism was caused by insufficient heating of commercial low-acid foods packaged in sealed containers and improper acidizing of commercial acidified foods. Therefore, the FDA released the following regulations: 21 CFR 108 (Emergency Permit Control), 21 CFR 113 (Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers), and 21 CFR 114 (Acidified Foods). The Code of Federal Regulations require the establishment which distributes acidified foods and low-acid canned foods in the U.S. to register with the FDA and file with the FDA information including each product, product type, container size and type, and processing method (registration and filing provisions on thermally processed low-acid foods packaged in hermetically sealed containers: 21 CFR 108.35; registration and filing provisions on acidified foods: 21 CFR 108.25).

1. Low-acid canned foods. The “low-acid canned foods” refer to the foods with a PH above 4.6 and a water activity above 0.85, which are firstly sealed in any containers and then thermally processed to sterilize, such as canned foods of most vegetables, mushrooms, tuna and coconut juice.

2. Acidified foods. Acidified foods refer to the low-acid foods which are mixed with the acid or the acid food to achieve the PH below 4.6 and the water activity above 0.85. Most of Chinese pickled foods and pickles belong to acidified foods.

The above two types of foods, imported or produced by the U.S. manufacturers, must be registered with the U.S. FDA before marketing.

Which type of FDA registration?

1. All Food Canning Establishments (FCE) must apply for the FCE number.

2. Apply for the “Submission Identifier (SID)” number. FCEs must submit the “Process Filings” to the FDA for each type of can. A SID number, which can be regarded as the product number, will be assigned. The product will be registered according to the type and the specification.

How to apply for the “FCE” number and the “SID” number?

3. Factory audit

3.1 Why does the FDA conduct overseas inspections of food enterprises?

The U.S. FDA will increase the number of routine inspections of all food establishments to meet the new regulations in the FDA Food Safety Modernization Act (FSMA) signed by the President on January 4, 2011.

The FDA’s overseas surveillance inspections are aimed at identifying potential food safety issues before products arrive in the U.S.;

Determining the compliance status of each establishment with the FDA’s related requirements and food safety standards;

Helping the FDA decide whether the food is allowed to enter the U.S.;

Helping ensure that the food products regulated by the FDA meet the requirements of the U.S. Federal Food, Drug, and Cosmetic Act.

These routine product inspections are not part of a public health emergency, but they are an important way for the FDA to ensure that the overseas food establishments that export their products to the U.S. and their products comply with various U.S. regulations.

These routine inspections are designed to assess whether the establishments comply with applicable U.S. laws, not to assess the food safety systems of the relevant authorities in the countries.

3.2 What is the focus of the FDA’s routine surveillance inspections?

The purpose of the FDA’s inspections is to determine the compliance of each establishment with the Federal Food, Drug, and Cosmetic Act and the relevant provisions of Title 21 of the Code of Federal Regulations (CFR), including Part 110 (Current Good Manufacturing Practice (GMP) in Manufacturing, Packing, or Holding Human Food) and any other U.S. regulations applicable to specific food product types.

For example, canned foods shall be inspected in accordance with the regulations governing low-acid canned or acidified foods set out in sections 113 and 114 of 21 CFR. Dietary supplements shall be inspected in accordance with the good manufacturing practices for dietary supplements in Part 111 of 21 CFR.

One inspection can focus on multiple requirements. For example, canned tuna products can be inspected in terms of the aquatic product hazard analysis critical control point (HACC) system, canned food production regulations, labeling regulations, and current GMP compliance.

3.3 What is the length of time for the FDA to conduct inspections in various countries?

The FDA will arrange multiple inspection trips to a certain country throughout the year. Each inspection trip usually lasts two to three weeks.

3.4 How many food establishments does the FDA plan to inspect in each country during each inspection period?

In two to three weeks, an inspection trip may cover four or more food establishments.

3.5 How long does it take the FDA to complete each inspection of food establishments?

According to the inspection focus, on-site observations and other aspects, the inspection of most foreign food establishments needs to last one to three days.

3.6 What can SUNGO do during the FDA factory audit?

According to the different needs of customers, we can provide pre-audit service or factory inspection counseling and accompanying service. The work includes:

a. Analyze the gap between the existing QMS and regulatory requirements;

b. Consult the overall design of the process, including the site correction and the correction of documentation system and application;

c. Review the document records and check the GMP of the whole production process and the GMP of the equipment and facilities maintenance based on the FDA audit requirements; the consultant and the relevant personnel of the enterprise correct the documentation system jointly;

d. Identify and correct the defects of workshops and warehouses;

e. Provide the audit skill training for relevant personnel of the enterprise;

f. Our auditor will conduct a simulated audit on the effectiveness of the system before the FDA audit;

g. Accompany the FDA factory inspection;  

h. Assist the enterprise to correct the nonconforming items.

4. Food label audit

We can audit food labels for our customers in accordance with the Guidance for Industry: Food Labeling Guide of the Center for Food Safety and Applied Nutrition, FDA, U.S. Department of Health and Human Services.

The evaluation contents generally include:

· Language on the label

· Font on the label

· List of ingredients

· Identification of allergens

· Identification of origin

· Nutrition facts

We will submit a label audit report to the customers, and we can also revise the labels directly for the customers.

Quotation Scheme for Medical Device

 Export to the European Market

Quotation principles for FDA food establishment registration

The FDA food registration fee is divided into establishment registration fee and product registration fee, in which the product registration is the food category declaration. The quotation principles are as follows:

1) In general, one charge for one enterprise;

2) The quotation for product registration is based on the product category.

Quotation principles for FCE-SID food registration

The FDA FCE-SID registration fee is divided into FCE registration fee and SID registration fee. The quotation principles are as follows:

1) FCE is based on the number of enterprises, usually one charge for one enterprise;

2) The quotation for SID product registration is based on the product category and the product’s process complexity.

Quotation principle for FDA factory inspection counseling

Most of the FDA factory inspection counseling work needs to be done on site, so our quotation is based on the number of person-days. The factors influencing the number of person-days include:

1) Enterprise scale;

2) Classes and batches of the products the enterprise exports to the U.S.;

3) Whether the enterprise has a management system basis, such as HACCP and ISO22000;

4) Whether the enterprise has a record of violations regarding the export to the U.S.;

5) Whether inspection accompanying and translation services are required;

6) In addition to the number of person-days in our normal counseling scheme, are there additional person-days required, such as testing support.

Quotation principles for FDA label audit

FDA label audit is an off-site audit service based on product labels. The quotation principles are as follows:

1) One charge for one category of product labels;

2) For different models of similar products of the enterprise, we suggest that the enterprise make modification by itself according to the template we provide.