FDA
REGISTRATION
MEDICAL DEVICE

FDA Medical Device Services

FDA Registration and US Agent

FDA Registration
and US Agent

FDA registration is a mandatory condition when exporting medical devices to the US market. However, the implementation process is quite complicated and requires a lot of information because this product directly affects the user’s health. We’ll make it easier for you to comply with the FDA.
Premarket-Notification-510(k)

Premarket
Notification 510(k)

Pre Market notification, also known as 510(k) notification, is an important procedure to bring medical device products to the US market. It’s difficult if a non-specialized person is in charge of this because 510(k) is a complicated procedure. Let us help you!

Pre Market Approval (PMA)

Pre Market
Approval (PMA)

Class III medical devices must submit a Premarket Approval Application (PMA). FDA premarket approval is a mandatory scientific review process designed to ensure the safety and effectiveness of Class III medical devices. You need highly specialized knowledge to complete the complex PMA process.

Medical Device Labeling

The FDA requires medical devices imported into the US to be labeled in accordance with regulations so that consumers receive full information about the product. Our experts will help you comply with FDA requirements with ease.

Device Classitification

Medical device classification is the process of determining the level of risk associated with a medical device, thereby determining the legal requirements applicable to that device. We will help you determine the exact type of medical device, helping you avoid unnecessary procedures

FDA Registration for
Medical Devices

FDA-Registration-for-Medical-Devices
Contact our experts for quick advice

FDA Registration and Renewal
for Medical Devices

The U.S. Food and Drug Administration (FDA) requires all medical device manufacturers and importers to register with the FDA. Registration is required for all medical devices, including those that are used for diagnostic, therapeutic, or preventive purposes.

Similar to Food and Beverage FDA registration, medical device FDA number also need to be renewed. However, according to FDA regulations, the FDA medical device number needs to be renewed annually between October 1 and December 31.

U.S Agent Service

A US Agent is also a mandatory requirement when you register your medical device with the FDA. You need a US Agent to act as a liaison between you and the FDA and handle requests made by the FDA.

More infomation about US Agent can be found here

Who Needs to Submit a 510(k) Submission?

Any person or company that wants to market a new medical device in the United States must submit a 510(k) submission to the FDA. This includes devices that are: Class I or II or III

A 510(k) filing is required if you fall under any of the following categories:

  • Manufacturers of medical devices in the United States who intend to market their devices domestically.
  • Developers of specifications for medical devices that are intended to be marketed in the United States.
  • Packers or relabelers of medical devices.
  • Foreign exporters or U.S. representatives of foreign exporters who intend to introduce a device into the U.S. market.
    If you fall under any of the above categories, contact us immediately to complete your 510(k) filing!

Under what circumstances are you exempt from filing a 510(k)?

Even so, you may still be eligible for a 510(k) exemption in some cases. Contact ABC immediately to find out if you are exempt from filing a 510(k)!

Premarket Notification
- 510(k)

Premarket Notification - 510(k)

The Food and Drug Administration (FDA) is responsible for ensuring the safety and effectiveness of medical devices sold in the United States. One of the most important requirements for medical device manufacturers is to submit a 510(k) premarket notification to the FDA.

Medical Device Labeling Service

The FDA regulates and provides guidance on medical device labeling. These regulations are found in Title 21 of the U.S. Code of Federal Regulations. Violating these regulations is a common reason for goods to be detained at the port of entry.

Medical device labeling is also a required part of the 510(k) Premarket Notification and Premarket Approval Application (PMA).

It is important to comply with FDA labeling requirements from the start to prevent unnecessary risks that may occur and impact the consumption of goods in the US market.

We are here to help you with that!

PMA (Pre Market Approval) -
a pass for Class III medical devices

According to Section 515 of the Federal Food, Drug, and Cosmetic Act, Class III medical devices must submit a Premarket Approval Application (PMA). FDA premarket approval is a mandatory scientific review process designed to ensure the safety and effectiveness of Class III medical devices, which are devices that:
Support or sustain human life.
Are of substantial importance in preventing impairment of human health.
Present a potential unreasonable risk of illness or injury.

PMA registration process

The PMA process is a complex and lengthy process that can take several years to complete. The process typically includes the following steps:

  1. Device classification: The FDA classifies medical devices based on their risk to patients. Class III devices are the highest risk devices and require PMA approval.
  2. PMA application: The device manufacturer submits a PMA application to the FDA. The application must include a comprehensive scientific dossier that demonstrates the safety and effectiveness of the device.
  3. FDA review: The FDA reviews the PMA application and may request additional information from the device manufacturer.
  4. FDA approval or denial: The FDA may approve or deny the PMA application.

Medical Device Classification

Medical device classification is an important step in determining whether the medical device is subject to a 510(k) market notification, a premarket approval application, or is exempt from these procedures.

class 1

Class I

These devices pose the lowest risk and are subject to the least regulatory oversight. Examples of Class I devices include bandages, tongue depressors, and thermometers.

class 2

Class II

These devices pose a moderate risk and are subject to more regulatory oversight than Class I devices. Examples of Class II devices include surgical gloves, contact lenses, and wheelchairs.

class 3

Class III

These devices pose the highest risk and are subject to the most regulatory oversight. Examples of Class III devices include pacemakers, implantable defibrillators, and surgical implants.

Medical device classification is a complex process that can be challenging, as a single device may fall into multiple categories. Accurately classifying a medical device from the outset is essential for ensuring compliance with FDA regulations and minimizing time and costs.

We are always here to assist you!

We will be your go-to team of experts, ready to help you with any issue.

We will contact you for consultation as soon as possible.