Why does it matter?
There are two important points to know about when importing medical devices. First, medical devices must comply with every standard of normal importation except you must also file the belongings in what is known as an MDR. Second, if the medical devices import radiation, there is a completely different process that you need to adhere to.
How to Import Medical Devices
Firstly, the manufacturer you are importing from must follow American regulations before they can be imported to the country.
Checklist of Foreign Regulations:
- Registration of Establishment
- Listing of Devices
- Manufacturing in Accordance with Quality Regulation
- Medical Reporting of Adverse Effects
- Premarket Notification 510(k) [Premarket Approval]
- U.S. Agent Designation
All of those must be strictly adhered to as a foreign manufacturer. But if you are an importer, the main change you must make is to follow an MDR filing.
Medical Device Reporting: The Form FDA 3500A is a report that the importer must have on-hand and report from the manufacturer. This report details reports of deaths or serious injuries as well as malfunctions associated with these medical devices.
You can read more about Medical Device Reporting here.
When a medical device emits radiation, it must follow-through a separated process from the typical importation. You must specifically follow the FFDC Act (Federal Food, Drug, Cosmetic Act) Subchapter C- Electronic Product Radiation Control.
Following these standards means you must follow these requirements.
Performance Standards – How much radiation will be emitted and how efficiently it is capable of doing so.
Proper Labeling – Contents of the device, what type of radiation is emitted and how many quantifiable units could be irradiated from the device.
Radiation Safety Reports – Detailed reports about how to properly handle the radiation and how strong the radiation could be.
Read more about the Electronic Product Radiation Control here.
With A1WWL, we work to remove as many hurdles between you and your products. If you want a smooth import of your medical devices, please give us a call before beginning the transition, we could save you a lot of headaches and setbacks between you and accessing your device.