Service Schemes for Medical Device Export to

 the European Market

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

1. For manufacturers producing cosmetics that do not contain active substances

· FDA cosmetics registration (including establishment registration and ingredient declaration)

· ISO22716 and GMPC counseling

· FDA cosmetics factory inspection counseling

· Recommendations for label audit and rectification

2. For manufacturers producing cosmetics that contain active substances

· FDA cosmetics registration and NDC registration of active substances

· FDA factory inspection counseling on drug regulations

· Recommendations for label audit and rectification

FDA cosmetics registration

The U.S. Voluntary Cosmetic Registration Program consists of two parts:

The first part is establishment registration;

The second part is cosmetic product ingredient statement, or CPIS, in which the enterprise must register every ingredient in its cosmetics with the FDA.

Timing of FDA cosmetics registration

1. The cosmetic establishment registration can be conducted before or after the export to the U.S. (within 30 days);

2. The cosmetic product registration shall be conducted after the export amount totaled USD 1000;

Process and cycle of FDA cosmetics registration

Fill in the FDA cosmetic enterprise application form with product ingredients

Apply for the FDA cosmetic establishment registration for the enterprise

Query the cosmetic ingredient code

Submit the application for registration of cosmetic ingredients to FDA and wait for manual approval

Obtain the FDA registration number upon successful registration

Normally, the registration cycle is 1 month. If rectification materials are to be provided, the time will be calculated separately.

ISO22716/GMPC cosmetics factory inspection counseling

ISO22716 Cosmetics - Good Manufacturing Practices

ISO22716 provides cosmetics manufacturers with operational guidelines for production, control, and storage. The standard covers management requirements for cosmetics manufacturers, including hardware and management system requirements. These requirements have been adopted by many enterprises in the cosmetics industry and recommended by European and international buyers.

Timing of ISO22716 introduction

For cosmetics manufacturers, we recommend that they consider introducing the ISO22716 standard once they export cosmetics. Of course, domestic enterprises hoping to explore the international market in the future may also consider the introduction of the ISO22716 standard to standardize the internal management system.

Process and cycle of ISO22716 service

Diagnosis of the current management system and issuance of the gap report

Planning of the introduction of ISO22716

Hardware modification

System establishment and personnel training

Trial operation and simulated audit

Recommendation of a third-party certification body to conduct the audit

Usually the counseling cycle is 2 months, and the audit cycle is 2 months;

It takes 4 months from initiation to obtaining a certificate from a third-party organization.

FDA cosmetics factory inspection counseling

It refers to the fact that when a cosmetics manufacturer is randomly selected by FDA for factory inspection, it needs to hire a third-party professional organization to provide consulting and counseling. FDA factory inspection is based on the Guidance for Industry Cosmetic Good Manufacturing Practices and the FOOD AND DRUG ADMINISTRATIONCOMPLIANCE PROGRAM

GUIDANCEMANUAL -COSMETIC MANUFACTURING INSPECTIONS.

Timing of FDA factory inspection counseling

Generally, the U.S. FDA will notify the enterprise about 2 months before the date of the audit. We suggest that the enterprise get in touch with us as soon as it receives the notice, because the overall preparation time is very short. Of course, we encourage the enterprises that have already exported their cosmetics to the U.S. but have not yet received the audit notice from the U.S. to seek our counseling, so as to get prepared.

Service process and cycle

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

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

3. Collect the existing documents: quality manuals, procedure documents, working instructions, process documents, inspection procedures, records, etc.

4. 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;

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

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

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

8. Accompany the FDA auditor and be responsible for translation and communication in the factory inspection.  

Cycle: it usually takes 2 months from receiving the notice to FDA completing the audit.

FDA cosmetics label audit and rectification services

FDA cosmetics label requirements

There are strict laws in the U.S. about the ingredients and labels of cosmetics, and there are specific requirements in CFR, Federal Register, VCRP cosmetic ingredients dictionary, guidelines, and U.S. FDA Labeling Manual.

Timing of FDA label audit

For cosmetics manufacturers, we recommend that they consider the compliance of labels once they export cosmetics to the U.S. Of course, domestic enterprises hoping to explore the U.S. market in the future may also consider this to get prepared early.

Process and cycle of FDA label audit

1. Appoint a consultant to review the information of labels and packages of cosmetics currently in use as submitted by the enterprise;

2. After the audit, we will submit:

· A detailed report (30-40 pages in general) after our regulatory expert team’s audit to all elements of the label (including inner package, outer package and website).

· A modified electronic drawing which can be printed directly.

3. If the same label is changed within 45 days, we will provide a new report and audit for free.

Usually the handling cycle is 15 working days.

Quotation Scheme for Medical Device

 Export to the European Market

Quotation principles for FDA cosmetics registration

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

1) In general, different enterprises are charged differently;

2) The quotation for product registration is based on the number of products and the number of ingredients to be declared.

Quotation principle for ISO22716 service

ISO22716 counseling needs to be carried out on site, so the fee is charged according to the number of person-days. The factors that determine the number of person-days involved in the counseling include:

1) The enterprise scale and the categories of cosmetics produced;

2) The complexity of the production process of cosmetics;

3) The strictness of the regulations in the destination countries where the cosmetics are sold;

4) The foundation of the enterprise itself, for example, whether it has passed ISO9001, and whether it has a documented management system.

The quotation for ISO22716 certification is also based on the number of person-days. However, of course, the certification body’s brand may affect more. We can recommend certification bodies with different brand awareness for enterprises to choose.

It shall be noted that the effective maintenance of the ISO22716 certificate requires annual supervision and audit. Therefore, there will be costs for system maintenance counseling, supervision and audit every year. The charging is still based on the number of person-days actually involved.

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 ISO22716;

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.