Ministry of Health

Department of Health and Human Services

Regulatory Authority

U.S. Food and Drug Administration (US FDA)

Medical Device Regulation

The Food and Drug Administration Amendments Act (FDAAA) of 2007

21 CFR 800 – 898

Medical Device Guidance

Official Language

English

Classification

Class I, II and III

Registration Process

• Determine the device classification
• Appoint an Authorized Representative – US Local Agent.
• In order to be marketed in the United States, all medical devices must be registered with the FDA. Manufacturing facilities are subjected to FDA inspections to ensure compliance with the American GMP requirements. In addition, each establishment where production, distribution, import and marketing of medical devices are performed in the U.S.A. must be disclosed and registered at the FDA, through Establishment Registration, in accordance with 21 CFR 807.
• The product registrations has two regulatory pathways – Premarket Notification (510k) or Premarket Approval (PMA)
• Class I and certain Class II devices may be subjected to a 510k regulatory pathway. The manufacturer will have to provide documentation to prove substantial equivalence to a similar US-marketed device. Once approved, US FDA shall send a notification authorizing the product to be marketed in the US market.
• Class III and certain Class II will be subjected to PMA regulatory pathway. Clinical trials should be performed and submit the technical documents to the US FDA. Once approved, a registration certificate shall be issued.
• The manufacturer may request for Pre-Submission meetings with the FDA at critical intervals during the product development process.

Documents Required

• Product Information
• Manufacturer Information
• QMS certificate
• Technical Documents
• Risk Management Plan
• Clinical Studies Report
• Postmarket Surveillance Plan

Post-market Requirements

• The Medical Device Reporting Regulations – 21 CFR Part 803
• Form FDA 3500A
• Death, Serious Injuries and Malfunctions – 30 days
• Substantial harm to public health – 5 days

Applicable QMS

21 CFR 820 – Quality Management System

ISO 13485

Registration Timeline

• Class I: 1 month
• Class II: 4-8 months
• Class III: 18-30 months.

Authorized Representative

Yes. US Local Agent

License Validity

The license does not expire unless there is a substantial change in the device.

The Establishment Registrations should be renewed annually.

Special Notes

Labelling – 21 CFR 801