Manufacturing Medical Devices During COVID-19? Know This…

By The Pro QC Quality Assurance Team

COVID-19 has turned up a number of challenges for the entire world, the global marketplace notwithstanding. However, one of the most pressing demands on the supply chain at present is a need for medical devices to help hospitals cope with enormous numbers of coronavirus patients. But how do parties ensure they are getting a quality product?

Inevitably, the coronavirus has posed several quality challenges for medical devices as well as medical products – due largely to the rising number of scams as people try to take advantage of the urgent need for quick production. At Pro QC, our auditors and inspectors have found several cases where the marketed product is not what it claims (e.g. industrial masks proclaiming to meet medical standards) or, in a worst case, not being produced at all.

Medical Device

Under normal circumstances, top producers for medical devices were China, Hong Kong, Taiwan, South Korea, India, and Vietnam. The main exporters in USD value terms were the United States, Germany, Netherlands, Mexico, China, Belgium, Ireland, Japan, Switzerland, and France.

However, with coronavirus lockdowns and major supply chain disruption ongoing around the world, exporting medical devices from countries such as Italy, France, Spain, the UK, and Belgium is almost impossible. While China has typically been first in terms of number of medical device shipments, it has only been fifth in terms of value for that particular market – this is an important note as despite the fact that China is opening up in terms of production, the likelihood of scams in the market is higher there as producers have not typically been as well versed in medical equipment production.

So, alternatives include looking at countries including Vietnam, Taiwan, South Korea, Germany, Hong Kong, Japan, Thailand, Singapore, Mexico, Brazil, Malaysia, and Sri Lanka.

However, medical devices and medical supplies are one of the most stringently regulated products on the market. Not only is it imperative to ensure the supplier is legally registered and has a declaration of conformity for its medical device product, but also that the product complies with market regulations (i.e. The FDA, CE, etc.).

Whether you’re new to medical device procurement, or an old hand, given the unusual COVID-19 circumstances, Pro QC recommends starting at the very beginning to get started: check in with your local customs agents regarding the medical device import process, and make sure you are fully informed before taking next steps.

Make sure any supplier you engage with provides you with relevant certificates for the market you intend to supply to. For the EU and UK market this is the ISO 13485 certificate, business license and CE certificate for the product you intend to purchase, and for the U.S. market, you will need an ISO 13845 or GMP for Medical Devices certificate, FDA factory registration certificate, FDA product registration certificate, and business license for the product.

We know that in this critical period of COVID-19 sometimes the speed of the purchase has a life and death criticality and speed of procurement is of utmost importance. If this is the case, we suggest to conduct a COVID-19 Supplier Verification. If we identify the supplier as low risk, you can then proceed onto next steps in the procurement process; however, we do not recommend you continue to engage with a high-risk supplier. In certain instances, Pro QC might even be able to conduct a remote audit to speed up the decision making.

Ensure the supplier confirms that they are able to export to your market, and make sure everything is confirmed in writing through contract and email. In this time of coronavirus it may not be possible to meet the supplier in person, so we suggest you conduct a face-call over a zoom chat or face-time in order to make sure you are dealing with a knowledgeable manufacturer, and not a scam-artist. Again, Pro QC can help with remote audits or verifications if necessary.

After making a purchase, we highly recommend conducting a product inspection of your medical device. This can either be a first-article, in-process or pre-shipment inspection and Pro QC is specialized in each worldwide. This will minimize risk and raise any red flags as to the product quality and whether the medical products have the relevant certificates from their supplier.

Above all, make sure you keep yourself well informed and up to date on constantly changing rules and regulations regarding shipments for medical supplies.

Pro QC is experienced in COVID-19 Supplier Verifications and Audits. Get in touch with us to see how we can work with you to get urgent medical device shipments well on their way to market.