FDA Compliance - Techlink

FDA Registration for Medical Devices

Techlink is an experienced FDA consulting firm. We are experienced in all aspects of FDA medical device approvals. We are here to help you get your products approved in the fastest, most efficient and economical way possible.

Medical Devices are divided into 3 groups, i.e., Class I, Class II and Class III

It is essential to prepare all materials in advance in order to make sure that the product will be granted approval.

Medical Devices are divided into 3 groups, i.e., Class I, Class II and Class III depending on the actual type of device, as assessed by the FDA. You will need to fill-in a 510(k) application form for most devices that fall within class I and II, unless otherwise specified. Applications are to be submitted to the FDA. Please note that there are more than 1,700 different types of medical devices as listed by the FDA and classified according to 16 medical specialties which appear below:

  • 862 – Chemistry / Toxicology
  • 864 – Hematology / Pathology
  • 866 – Immunology / Microbiology
  • 868 – Anesthesiology
  • 870 – Cardiovascular
  • 782 – Dental
  • 874 – Ear, Nose and Throat
  • 876 – Gastro / Urology
  • 878 – General Plastic Surgery
  • 880 – General Hospital
  • 882 – Neurological
  • 884 – Obstetrical / Gynecological
  • 886 – Ophtalmic
  • 888 – Orthopedic
  • 890 – Physical Medicine
  • 892 – Radiology

To make sure that your Medical Device makes it on the US market, it is essential to go through a consulting company which will be able to provide you with all-round services from A to Z as well as make the right assessment, and apply for the relevant documents with the FDA since you will not be given any template allowing you to fit your medical device into a specific category. Many people find the process lengthy and difficult to go through alone. TechLink International, Inc guarantees you professional and efficient services. We have helped many commercialize hundreds of medical devices from product concept to its actual commercialization and we can proudly say that our clients are satisfied customers. Our experts have been dealing with FDA Medical Device Regulations for over 17 years.

You can trust us. Your business is our business.
Your Trusted Source For Compliance.