On this page, we’re collecting resources that are helpful for anyone who’s importing medical devices into their country from abroad (especially China and the rest of Asia).

EU MDR (Medical Device Regulation)

The EU MDR is a serious challenge for importers of medical devices into European Union countries. Learn why this new regulation improves safety and compliance but can make becoming compliant far more difficult in these resources:

Coronavirus Medical Supplies

Since the coronavirus pandemic began in 2020 sales of medical supplies like PPE have exploded. Here are resources* to help you navigate this treacherous product category if you’re importing them:
*(from both Sofeast.com and QualityInspection.org)

Various solutions Sofeast provide that can help you find and buy medical devices with more peace of mind

If you’re importing medical devices, we can help you…

  • Supplier due diligence – You need to be sure that your new supplier of medical devices is reputable and is capable of providing you with safe and compliant goods. We can help confirm this.
  • Certificates verification – As an importer of medical devices, you’re going to be held liable for any issues they cause, such as patient illness or injury. With this in mind, you can’t afford to purchase regulated and high-risk products like these without confirming that your supplier has provided you with legitimate and relevant certificates and reports. Our experts do the research and give you confirmation.
  • Factory Audits – Before you start working with a supplier and money changes hands, we send an auditor to their factory and report on their processes, what they are making, and whether their quality system is reliable so you can rest assured that they are suitable.
  • Product QC Inspections – Medical devices, more than almost all other product types, can’t afford to be defective. Performing product inspections throughout production at your supplier’s facility will assure that you don’t receive any non-compliant or unsellable products.

Comments are closed.