We're Buying Medical Devices From China And Are Worried Our Supplier Isn't Legit | Disputes With Chinese Suppliers Q&A (Volume 8)Unfortunately, the Covid-19 pandemic is still with us here in summer 2021 and so there’s still a great interest in purchasing medical devices such as medical-grade nitrile gloves, gowns, and surgical masks from China for use in hospitals and other healthcare settings. I’ve already written a number of posts about medical devices and PPE and the risks you face, such as this one, but if you really need to source and purchase medical supplies I’ll share some steps you can take to stay safe here.

 

“We’ve found a supplier of medical devices, but we’re worried they aren’t legitimate. What can we do?”

This is a recent customer query. They were planning to import nitrile gloves and other medical devices that can be used as personal protective equipment in a medical setting from a Chinese company, but something seemed off about the amount of information they were being given. They were worried that they were not a real manufacturer and, in fact, a third party or trading company masquerading as one instead.

Why does it matter if a supplier is a trading company?

There are a number of issues you’ll face when dealing with a trading company that is claiming to be a manufacturer:

  • Your relationship is built on dishonesty which is no way to go forward.
  • They’re adding a margin to the ‘real’ cost of the products from the manufacturer, but this could be a large amount.
  • The trading company may not assure that the factory is producing certified and compliant products which is a big problem with medical devices (remember the issues with substandard Chinese KN95 masks being sent to the West in the early days of the pandemic), as their primary goal is to sell and make money, not necessarily to worry about your compliance (the same goes for product quality).
  • They may deal with a factory they have a relationship with, but who is not the best option for you.
  • They may not know who the factory’s sub-suppliers are, meaning that you, the buyer, have zero control over your supply chain.

Given that vendors of PPE are likely to be held responsible for any users’ injuries or illnesses caused by their products were there to be problems with the products, it’s especially important to be 100% certain that you’re dealing with a real manufacturer producing compliant products and that you have control and visibility over your supply chain.

So, how to get this peace of mind if the potential supplier isn’t forthcoming with the information you need?

 

Safety first when vetting medical device suppliers

When vetting suppliers that you’ve found it’s always smart to take the time to do a background check and audit the factory. Let’s look into those activities in more detail:

Running a background check

An excellent start is to get the potential supplier’s Chinese company name and address. Once you have that it’s possible to find official legal records which should give you a good indication of the legitimacy of the company and if they’re being upfront and honest with you, such as if they are actually a manufacturer.

If you have Chinese employees they may be able to check the government’s legal records which are kept on file by the local government, otherwise, you can get help from a company that specializes in this kind of work.

馃憠 Get help to do this from Sofeast: One of our most popular services is the Legal Records Check (LRC) for only 99 USD (for 1 company). If a supplier is not a manufacturer, it is pretty obvious after an LRC.
You may also find a Certificates & Reports Verification check helpful for confirming the veracity of a supplier’s medical device certification and this is also 99 USD per product and manufacturer.

Performing a factory audit

Understanding that the supplier is capable of producing compliant medical devices is critical for user safety and to protect your business. In this case, the manufacturer of nitrile gloves will be assessed on their ability to produce gloves to the EN 455-2:2015 standard for the EU or in adherence to the Federal Food, Drug, and Cosmetic Act (Act); 21 U.S.C. 360c(a)(1)(A) in the USA.

Sending a member of staff who is capable of evaluating their capabilities and quality management system on-site will be a very effective way to check that they are able to reach your needs, that the materials they use are correct, and that they’re certified and testing the products correctly. Otherwise, work with a local auditing company that can send a qualified auditor that understands PPE and your needs, instead.

馃憠 Get help to do this from Sofeast: We can help you do an on-site evaluation of the supplier’s capabilities and QMS by sending an auditor to your supplier anywhere in China. 聽With supplier cooperation, we can complete the on-site work quickly, and issue the report to you within a few days. Our most popular audit is the IFE (Initial Factory Evaluation), for just 279 USD per factory (you can also read about our other factory audits on that page, too).

 

Conclusion

The medical device market is still a minefield. It isn’t worth taking the chance of importing goods that, at best, you can’t sell, or at worst land you in court with a hefty injury suit.

Start by performing due diligence on the company by performing a legal records check if you’re suspicious of their status and motives.

Then, check that they are capable of providing you with the medical devices that reach your market’s requirements by sending in an auditor to check their operations in person. If you’re placing a large enough order the supplier shouldn’t object to this as a prerequisite to dealing with you.


 

P.S.

Read these resources about importing medical devices for pandemic control for even more information:

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