Does your medical device company import components, parts, or materials used in the development or manufacturing of new devices? There are specific procedures you must go through to get your imported products through not only the FDA, but also through United States Customs.
Today’s guest is John Johnson, a senior associate attorney at FDAImports.com and the Benjamin L. England & Associates law firm. He will talk to us about some of the challenges associated with getting products into the USA. As someone who works carefully with companies comply with pre- and post-market investigations, John is qualified to give some great advice, so you won’t want to miss the interview.
Some of the highlights of the show include:
- The FDA’s role after market clearance is obtained and as it relates to imports. John talks about how the FDA interacts with devices after they are imported.
- Some thoughts on what is driving the increase of FDA import inspections.
- How an importer can get through the process of getting permission, having the compliance checked, getting a customs broker, and the other logistics of importing a medical device.
- Tips on actions to take when various alerts and letters are received from the FDA.
- Common mistakes that you should try to avoid that importers often make.
- Why QSR inspections can make or break your ability to work with an international company.
- Tips for getting through the customs process, which is an issue separate from FDA approval.
“If the FDA sees a failure in one company’s device... there may be a categorical problem and they may start inspecting other people’s devices.”
“When you are an importer of record, you have obligations to the government.”
“If you're using a third-party supplier, do your due diligence.... Make sure you know what their compliance status is.”
About The Global Medical Device Podcast:
The Global Medical Device Podcast powered by greenlight.guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.