Trust An IOR To Meet Customs Compliance For Medical Devices

Exporters and importers of medical devices need to deal with many compliance issues, as there is a large list of regulations and rules in place for shipping across borders. Equipment for clinical trials, disposable products, diagnostics and testing devices, centrifuges, ECG machines, refrigerators, and computers are all highly regulated. Each nation has different rules that need to be obeyed as well as paperwork completed, including licenses, permits, and other documentation according to the class of the device. These considerations, on top of a whole host of every day shipping guidelines that every importer needs to meet, means it’s incredibly complex to send medical devices to foreign destinations. To confidently meet compliance, using an Importer of Record (IOR) is a safe decision.

To ensure this compliance, those shipping medical devices may need to know and/or prepare:

  • The class of the medical devices (Class I to Class IV)
  • Establishment Registration or License for the manufacturer
  • If there is a valid Device Listing available
  • If a 510k (Pre-Market Notification) is necessary
  • If Pre-Market Approval is required
  • Following proper labelling compliance
  • Special considerations for Investigational, Custom, or Special devices
  • Meeting the standards of Good Manufacturing Practices and Quality System Regulation
  • Proper documentation to protect Intellectual Property, if applicable
  • Records proving Reasonable Care
  • Use the correct tariff and customs schedules

And that is a quick survey of only some of the considerations.Some entities are exempt from these preparations. Borders set many rules for health and safety reasons. Protection agencies are concerned with the informed use of food, drugs, and health products (wherein medical devices are included) to increase both their safety and efficacy for the general population. Additional agencies beyond the Health, Food & Drug realms can place additional rules on the same shipments. Therefore, these items are highly scrutinized at the border and can be delayed for lengthy periods until whatever flag(s) have been placed have been properly dealt with, usually with the help of expensive legal consultation after the fact.

These detailed preparations need to be tailored to each individual country that is receiving the goods. That’s why importer services handled by an expert Importer of Record is important. Businesses can outsource their international importing needs with those experienced with shipping medical devices to virtually any nation around the globe and reduce the associated costs with worldwide shipping. TecEx offers IOR services, secure supply chain solutions, and tax recovery in 180 destination countries.They work with industry leaders in the pharmaceutical, medical, and technology space like Portola Pharmaceuticals, ProceptBioRobotics, and Ancillare. They promise hassle-free, first-time customs clearance for clinical trial, diagnostic, testing, and other medical products. For those incurring indirect taxes in foreign nations, they also assist with tax refunds, combining all the necessary requirements for importing and reducing costs with one point of contact.

For health and safety reasons, and for the urgent nature of medical research and testing, it’s vital to not have medical devices and equipment stuck at the border. Partnering with an experienced Importer of Record will guarantee a streamlined cross-border transaction and safe delivery of all goods.

Adam Torkildson