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:
- How The EU MDR Will Change The Medical Device Industry Forever [Podcast]
- New EU MDR: Who Are The “Economic Operators” For Imported Devices?
- EU MDR Changes: Are You Selling a Medical Device, and What Class Is It?
- EU MDR Update: How To Get a New Medical Device Certified? [Flow Charts]
And from our CEO’s personal blog, QualityInspection.org:
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)
Blog Posts About PPE And Other Coronavirus Prevention Supplies
- What are the effects of coronavirus on importers with a China supply chain? [Webinar]
- Buying face masks from China? 5 Examples To Avoid
- Face Mask Regulations and China Export Challenges For Buyers During The Coronavirus Pandemic
- How To Work With Sofeast To Obtain & Import Coronavirus Medical Supplies & PPE [FAQs]
- How To Get Responses To Inquiries For PPE Products From Chinese Suppliers? 5 Tips
- How Long To Wear Surgical Masks & N95 Respirators For Best Performance
- Buyers of Masks and other PPE: Are You Exposed to Serious Liability?
- Requirements To Import PPE: You Need To Go Beyond Certificates
- Verifying Certificates for Masks, Gloves, and Other PPE from China
- 9 Reasons Why You Can’t Buy Face Masks with Low Risk in China
- Advice for Buying Face Masks in China without Losing your Shirt