How to enter the U.S. market for medical devices FDA registration application considerations

<> U.S. FDA defines medical devices as follows: The so-called medical device refers to instruments, equipment, appliances, machines, appliances, implants, in vitro reagents and other similar or related items, including parts or accessories, that meet the following conditions. Affects the structural functions of humans or other animals, and is not intended to be used by chemical reactions within humans or animals, nor is it dependent on metabolic changes to obtain any of its intended uses.

The FDA clearly stipulates its product classification and management requirements for each medical device, and there are currently more than 1,700 kinds of medical device products in the FDA medical device product catalog. According to the different risk levels, the FDA divides medical devices into three categories ( , Class I is a "general management" product, which refers to a product with little or no danger, accounting for about 25% of all medical device varieties, and most of the Class I devices can be registered directly. It is classified as a "standard management" product, which refers to a product with a certain degree of risk, accounting for about 55% of all medical device varieties, and most products need to obtain 510K.

Classes are products that are more dangerous or hazardous, or used to support and maintain life, accounting for about 20% of all medical device varieties. Implement a "pre-market approval" (PMA) system.

In addition to registration, most devices also need to apply for a unique medical device identification number (UDI) and upload it to the FDA's GUDID database. Medical device companies also need to do a good job in the system, you can refer to QSR820.

Summary. Hello, it is illegal for medical devices to be sold in the US market without being sold by the FDA. Moreover, FDA is required to be inspected by the customs, and the goods cannot be cleared without it, and if the recipient cannot receive the goods, there is no way to return them.

It will cause you a lot of financial losses.

Good. Hello, it is illegal for medical devices to be sold in the US market without being sold by the FDA. Moreover, the customs inspection of the family socks is required to provide FDA, if there is no goods can not be cleared, the recipient of the trillion family can not receive the goods, and there is no way to return it.

It will cause you a lot of financial losses.

What's more, the current situation in China and the United States is very tense.

The goods have been sold in the U.S. market and found out later.

The political situation is very serious, and it is very difficult to build a beautiful country.

It is recommended that you consider taking the channel of package customs clearance, Peru, Chile, or Brazil, and yes, Russia.

FDA implements classified management of medical devices, and divides medical devices into three categories according to the risk level and management degree ( , pre-market management, and the highest risk level. The FDA clearly stipulates the product classification and management requirements for each medical device, and any medical device that wants to enter the U.S. market must first clarify the classification and management requirements for the product applied for marketing.

After clarifying the above information, the enterprise can start to prepare the relevant application materials and declare to the FDA according to certain procedures to obtain FDA certification approval for medical devices. For any product, companies need to register and list their products.

U.S. FDA Medical Device Certification Registration Process:

Medical device FDA510K registration

Pre-IPO Notice (510(k)).

A 510(k) is a premarket submission to FDA that certifies that the device is at least safe and effective for sale on the market, that is, substantially equivalent to a legally marketed device (21 CFR a)(3)). Submitters must compare one or more similar legally marketed devices to make their devices and support them substantially equivalent.

FDA510(k) Exempt Registration for Medical Devices:

It consists of two parts: business registration and product listing. After the registration is completed, you can enter the corresponding registration code, query code, or enterprise name to check the relevant information on the FDA official website. The fee includes two aspects, one is the FDA annual fee charged by the United States, which is paid directly to the FDA treasury in the form of US dollars, and the annual fee for the next year is renewed from October 1 to December 31 of each year to maintain the validity of the FDA registration, and the amount of the annual fee varies every year.

The other is the ** fee charged (which includes company registration, product registration, and ** people in the United States).

After successful registration, there will be three numbers: registration or feinumber; Owner Operator Number and Listing Number

First, there will be the property owner identification number, the owner operator, the product registration number and the listing number, which can be directly cleared.

Facilities that have been registered, but have not yet obtained the "Medical Device Facility Registration Number", may temporarily use this number as the "Medical Device Facility Registration Number" for export declaration. Registration or FEI number needs to be assigned by the FDA.

The differences are as follows:

1. FDA is the 510K registration certificate for medical self-treatment devices in the United States; Bai and medical device registration certificate du is commonly used to say that domestic medical device registration certificate;

2. Through DAOFDA certification, enterprises must have QSR820 system certification, and then the product can apply for 510K registration certificate;

The domestic medical device registration certificate, only need to handle the YY0287 audit report, you can, 3, FDA registration certificate is expensive, the cycle is long, there is an annual inspection fee, about 1200 US dollars;

FDA is a copy of food and medicine.

Food and Drug Administration (Food and Drug Administration) is the direct law enforcement agency of the United States, specializing in the regulation of food, drugs, cosmetics and medical devices. It is a monitoring body composed of professionals such as doctors, lawyers, microbiologists, pharmacologists, chemists and statisticians dedicated to protecting, promoting and improving the health of the people.

FDA certification refers to a qualification that requires access to the U.S. market - food, drugs, cosmetics and medical devices and other products must comply with relevant U.S. regulations and be recognized by the United States**.

Every country has a regulatory process for medical devices, the United States is FDA, Europe is CE, China is SFDA, and so on.

In layman's terms, the medical device application method in the FDA is the medical device registration method in the United States, or according to your statement, the FDA's medical device K number is the medical device registration certificate.

Aoshida Medical Device Consulting Agency (Guangzhou, Beijing, Shanghai, Suzhou, Shenzhen, Jinan, USA).

This area is not very big.

It is an American medical device.

zhi510k registration.

DAO certificates; The medical device registration certificate is usually the domestic medical device registration certificate;

2.Through FDA certification, enterprises must have QSR820 system certification, and then the product can apply for 510K registration certificate;

The domestic medical device registration certificate, only need to handle the YY0287 audit report, you can, the registration certificate is expensive, the cycle is long, and there is an annual inspection fee, about 1200 US dollars;

However, medical devices entering the United States must have FDA certification before they can be sold on the market

According to different risk levels, the FDA divides medical devices into three categories ( , with the highest risk level and the most stringent supervision. More than 1,700 products are included in the FDA's Medical Device Catalog. Any medical device that wants to enter the U.S. market must be under FDA supervision.

Class medical devices: general control

These devices, such as crutches, spectacle lenses, adhesive tapes, etc., account for about 47% of all medical devices as long as they are subject to general control.

These include: prohibiting the sale of shoddy and improperly labelled products; FDA may prohibit the sale of non-conforming products; Must report FDA-related hazards, repairs, replacements, etc.; Restrict the sale, sale, and use of certain equipment.

Implementation of GMP: Domestic manufacturers, importers, and sellers are required to register with the FDA, and manufacturers must list the products they manufacture, as well as Class II and Class III.

Class medical devices: special control

These products, which are subject to special requirements set by the FDA or other industry-recognized standards, include medical gloves, electric wheelchairs, hearing aids, blood pressure monitors, diagnostic catheters, etc., accounting for about 46% of all equipment. Among the FDA's special requirements, there are mandatory performance standards, patient registration and post-market surveillance for specific products.

Class medical devices: pre-market approval

Most of these products are life-sustaining, life-sustaining or implanted devices that are potentially dangerous to patients and may cause injury or illness, such as heart rhythm regulators, intrauterine devices and baby incubators, accounting for about 7% of all devices. These devices must be approved by the FDA for PMA before they can be sold.