Service Schemes for Medical Device Export to

 the European Market

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

1. Determine the specific class of the medical device in the U.S. FDA

2. Serve as your U.S. agent

3. Perform the FDA medical device establishment registration and product listing (including the guidance for the payment of the FDA annual fee)

4. Counsel on the medical device FDA 510(k) registration

5. Counsel on the QSR 820 quality system establishment

6. Counsel on and accompany the FDA official audit

1. Determine the specific class of the medical device in the U.S. FDA

Who regulates the medical devices in the U.S.?

Medical devices that are intended for sale in the U.S. will be regulated by the Food and Drug Administration (FDA). They shall also comply with relevant regulations and controls, and be subject to the corresponding market regulation approaches based on different device risks.

What is the FDA?

The FDA is the abbreviation of the U.S. Food and Drug Administration, which is subordinate to the Public Health Service under the U.S. Department of Health and Human Services, the U.S. Department of State.

The FDA is an international authority for medical audit and empowered by the United States Congress, i.e. the Federal Government. It is the highest law enforcement agency for the administration of food, drugs, medical devices, radiation-emitting products, vaccines, blood and biological products, animal and veterinary products, cosmetics and tobacco products.

How does the FDA classify medical devices?

The FDA regulates the medical devices through its Center for Devices and Radiological Health (CDRH).

1) According to the device risk level

The FDA implements a three-level regulatory system, which divides the medical devices into three classes, Class I, Class II and Class III, from low to high risks they bring to patients or users. The higher the class is, the stricter the regulation will be. 

See the following table for details:

2) According to the intended use

The FDA divides the existing medical devices into 16 categories and 1,700 kinds, containing nearly 6,000 product codes.

Each product code needs to correspond to a Medical Device Listing Number (MDL) before the medical device can be legally cleared by the U.S. Customs and marketed in the U.S.

3) What can SUNGO do when determining the class of your medical device?

The U.S. FDA uses a prototype-based classification system for the medical devices.

In most cases, you can determine the correct class of your medical device and the corresponding product code through the relevant resources on the FDA’s website. However, while this may seem easy, it is often difficult to find the closest prototype for your medical device from the thousands of different codes in the FDA’s database.

SUNGO has many years of experience and in-depth knowledge of the FDA’s classification database to help you correctly classify your medical device.

4) Other resources

For more information about the regulatory controls (general and special controls) that may be applicable to your device, see the Regulatory Controls page.

 https://www.fda.gov/medical-devices/overview-device-regulation/regulatory-controls

The following resources can help you determine the class of your device:

· FDA Product Classification Database

· Device Classification Panels

· Classify Your Medical Device

· Medical Device Accessories

2. Serve as your U.S. agent

21CFR Part 807.40(a) requires any overseas manufacturer engaged in the production, preparation, combination or processing of the finished medical devices and importing the products to the U.S. to undergo the Establishment Registration and Medical Device Listing.

The information about the U.S. agent of each overseas enterprise shall be submitted electronically via the FDA Unified Registration and Listing System (FURLS), which is part of the establishment registration process. Each foreign enterprise may designate only one U.S. agent. The foreign enterprise shall provide the name, address, telephone number, fax number and E-mail address of the U.S. agent.

The identified U.S. agents will be required to complete an automatic program to confirm that they have agreed to act as the U.S. agents. The automatic program will forward the E-mail of verification request to the U.S. agents. They will be required to confirm that they have agreed to act as the representatives/liaisons on behalf of the foreign enterprises. If the U.S. agent refuses (or does not reply within 10 working days), the official correspondent/owner operator of the foreign enterprise will be notified and must appoint a new U.S. agent to perform the regulatory obligations.

As required by the CFR 807.40(b), the duties of a U.S. agent include:

1) Assist the FDA to communicate with foreign manufacturers as required by the FDA;

2) Reply to the problems of products imported into the U.S. by foreign manufacturers;

3) Assist the FDA to arrange manufacturer inspection activities for foreign manufacturers;

4) If the FDA is unable to contact foreign enterprises directly or promptly, the FDA may provide information or documents for the U.S. agents, and such an action shall be deemed equivalent to providing the same information or documents for the foreign enterprises.

3. Perform the FDA medical device establishment registration and product listing

Process of FDA medical device establishment registration and product listing

1) Fill out the FDA medical device enterprise application form

2) Query the classification code of the medical device

3) Apply for the payment code, guide the payment and obtain the receiving code

4) Apply for the FDA medical device establishment registration

5) Submit the registration, and get the enterprise operation number and product listing number

FDA registration cycle

The total registration cycle is usually 1 to 2 weeks (provided that the enterprise pays the annual fee to the U.S. FDA without delay).

The specific time is as follows:

Day 1 After confirming the receipt of the service fee you paid to Sungo, we establish the project;

Day 2-4 We apply for the PIN (Payment Identification Number) for you, provide you with the payment guide, and guide you to pay the annual fee to the FDA.

Day 5-9 The FDA confirms the receipt of the annual fee in USD and issues the Payment Confirmation Number (PCN);

Day 10-13 We complete the establishment registration and product listing according to the application form you fill out.

You will then get: instantly generated owner number and listing number.

However, the registration number is assigned by the FDA’s background system, which will be assigned about 90 days after the registration is completed.

FDA registration validity period

From October 1 of a year to September 30 of the following year, it is a validity period of the FDA registration.

If the registration is completed on October 10, 2020, it will be valid until September 30, 2021.

The U.S. FDA requires that the registration information be updated annually between October 1 and December 31 each year.

4. Counsel on the medical device FDA 510(k) registration

When does the enterprise need to apply for the 510(k) pre-market notification?

Typically, to market a Class II medical device (and a small number of Class I and III devices) or an in vitro diagnostic device (IVD) in the U.S., the manufacturer must submit an application for 510(k) pre-market notification to the FDA.  

The manufacturer must also submit a 510(k) pre-market notification in the event of a change in the intended use of its medical device or a change in the technology of an approved medical device and the change may significantly affect the safety or effectiveness of the device.

The rationale for the FDA 510(K) is demonstrating that a new or modified device is substantially equivalent to a device already legally marketed in the U.S.

Contents of FDA510K declaration counseling

1) Determine the class and code of the product according to the product information

2) Find out the corresponding registration guide or relevant documents according to the determined product code, assist you in finding out the appropriate comparable devices, and determine the data and testing items that you should prepare

3) Provide the regulatory and technical support when you prepare the data and the testing

4) Prepare the 510K report according to the relevant data you provide

5) Guide you to submit the small enterprise qualification application to the FDA (the final approval is decided by the FDA)

6) Apply for the payment number from the FDA and guide you to pay the report review fee to the FDA

7) Submit the 510K report to the FDA for review, communicate with the FDA, and guide and assist the enterprise to rectify until the completion of project review

Basic process and cycle of FDA 510K declaration

5. Counsel on the QSR 820 quality system establishment

QSR 820 Medical Devices - Good Manufacturing Practices

The U.S. FDA requires the medical device manufacturers to implement a quality system that complies with the Medical Device Quality System Regulation (QSR) in 21 CFR Part 820. This quality system specification (QSR820) is similar to, but not identical to, the ISO 13485 standard on quality management system.

Who must establish a quality system according to the U.S. FDA QSR820?

1) Each enterprise that manufactures a medical device or an in vitro diagnostic device (IVD);

2) Each enterprise responsible for the design and development of medical devices and the related activities after their marketing. Therefore, most companies selling medical devices or in vitro diagnostic devices (IVD) must establish a QSR820 quality management system.

Timing of QSR 820 introduction

For medical device manufacturers, we recommend that they consider introducing the QSR 820 standard once they export medical devices. Every fiscal year, the U.S. FDA will conduct random inspection for overseas official factory audit. In order to avoid receiving a Warning Letter when the FDA conducts a random inspection on your factory in the future, which may affect your shipment, it is recommended that you introduce the QSR820 standard as soon as possible. We can also provide you with legal training related to the QSR820 system.

Process and cycle of QSR 820 service

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

2) Planning of the introduction of QSR 820

3) Hardware modification

4) System establishment and personnel training

5) Trial operation and simulated audit

Usually, after the release of the system documents, the system will be put into trial operation for three months, so the whole counseling cycle is 4-6 months.

6. Counseling on FDA medical device factory inspection

It refers to the fact that when a medical device manufacturer is randomly selected by the U.S. FDA for factory inspection, it needs to hire a third-party professional organization to provide consulting and counseling.

The basis of the FDA factory inspection is as follows:

1) Legal basis -- Food, Drug, and Cosmetic Act( FD&C ACT)

2) Regulation -- 21 CFR PART 820, or QSR (formerly known as cGMP)

21 CFR PART 803, or MDR (Medical Device Adverse Reaction Report)

21 CFR PART 801, regulations on labels

21 CFR PART 807, regulations on manufacturer registration, 510(K), etc.

3) Audit Guide -- Quality System Inspection Technique (QSIT)

The four parts of QSIT are:  management control, design control, production and process control (p&pc), and corrective and preventive actions (CAPA)

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 medical devices 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 the receipt of the notice to the completion of the FDA’s audit.

Quotation Scheme for Medical Device

 Export to the European Market

Quotation principles for FDA medical device establishment registration and product listing

The FDA medical device registration fee is divided into two parts, mainly the annual certification fee charged by the U.S. FDA and the service fee charged by us. The quotation principles are as follows:

1) Annual certification fee charged by the U.S. FDA: usually the fee is charged once for each enterprise in each validity period. The charging standard is implemented uniformly and globally. Generally, the specific amount is officially announced by the U.S. from the end of July to the beginning of August each year. For example, the Annual Establishment Registration Fee for fiscal year 2021 is $ 5,546;

2) Service fee we charge: the quotation is based on the number of products.

Charging principles for FDA510K service

It is divided into 3 parts, mainly the report review fee charged by the U.S. FDA, service fee charged by us, and testing fee charged by third-party laboratories. The charging principles are as follows:

1) Report review fee charged by the U.S. FDA: usually the fee is charged once for each report. The charging standard is implemented uniformly and globally. Generally, the specific amount is officially announced by the U.S. from the end of July to the beginning of August each year. For example, the review fee for a report in fiscal year 2021 is $ 12,432.

2) Service fee we charge: the quotation is determined after the workload is assessed based on the complexity of the specific product.

3) Testing fee charged by third-party laboratories: according to the specific testing items, the laboratories will issue the specific quotation.

Brief summary: generally, the application for 510K declaration of a product will cost at least RMB 200,000 in total.

Quotation principle for QSR 820 system establishment counseling

QSR 820 system 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 scale of enterprise and the categories of medical devices produced;

2) The complexity of the manufacturing process of medical devices, and the risk level when being classified by the U.S. FDA;

3) The foundation of the enterprise itself, for example, whether it has passed ISO13485, whether it has a documented management system, and whether there is any staff with good English skills.

It should be noted that after the QSR 820 quality system is established, it is passively subject to the random inspection by the U.S. FDA, in which case the auditor is an official staff of the FDA, and the FDA will not charge any fee. The FDA overseas factory inspection is a powerful means to ensure that medical device manufacturers actually comply with the requirements of the U.S. QSR820 regulations.

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) Scale of enterprise;

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 ISO13485;

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.