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
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.