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Latest Asia Manufacturing Trends and Upcoming Regulations Overview (Dec ’22)

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Latest Asia Manufacturing Trends and Upcoming Regulations Overview (Dec ’22)

On December 13th 2022, our CEO Renaud joined Global Sources‘ Tom McGrenery for a fireside chat about some of the broad Asian manufacturing trends we’ve seen recently, as well as the new regulatory frameworks for manufacturing, new technologies or services. They also cover some of the new American and European regulations that are coming up and are likely to impact importers, and what steps you should take right now in your business to tackle them.

The discussion went out live, but in case you missed it here’s the video that you can now play at your convenience and enjoy:

 

 

In summary, they discuss these three key trends:

  • Concerns over manufacturing in China given what many importers perceive as a more unstable and risky environment there now.
  • Where to move manufacturing to outside of China if diversifying one’s supply chain. Vietnam’s capacity is quite full and they lack export-ready manufacturing units. India is picking up the slack and developing its capacity now and is a good option for many product types.
  • Upcoming regulations affecting manufacturers in the EU and USA – in particular the drive for more transparency over one’s supply chain including the American UFLPA (Uyghur Forced Labor Protection Act), EU MDR (Medical Devices Regulation) 2021, EU EPR Extended Producer Responsibility 2022 (a company must be paid to recycle the products at end of life), and Recycled Plastic Food Contact Materials 2022 (documenting the manufacturing process of these materials). They also talk about the EU ban on modern slavery, ESG reporting for investor-driven improvement requirements, and the EU Ecodesign regulation and which product types it targets soon.

They also share these tips on steps you can take now to deal with the above:

  • Gather supply chain information (key materials and components and where they’re from, etc) for a future lifecycle assessment
  • Include checkpoints in your supplier qualification process that penalise suppliers who won’t provide supply chain/product/material information so you can weed them out
  • Gain an understanding of the environmental impact of your products (energy usage, materials used, recyclability, where they are made so modern slavery is avoided, etc)

*****

Let us know if this video has made you think of any questions about manufacturing in China or elsewhere in Asia or something more specific about getting your product made.

EU MDR Update: How To Get a New Medical Device Certified? [Flow Charts]

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EU MDR Update: How To Get a New Medical Device Certified? [Flow Charts]If you are developing a new medical device for sale in the EU, the EU MDR update affects you as you must now get it certified to the EU MDR regulation. 

But what is the path to get it certified? It very much depends on its ‘class’. 

In a previous article, we explained how to confirm if your product is considered ‘medical’ in the European Union. We also described the logic applied to determine how medical devices are classified.

In this article, let’s look at the path to certification for the different classes of medical devices in this new EU MDR update.

Continue reading “EU MDR Update: How To Get a New Medical Device Certified? [Flow Charts]”

EU MDR Changes: Are You Selling a Medical Device, and What Class Is It?

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EU MDR Changes: Are You Selling a Medical Device, and What Class Is It?

If you make, import, or distribute products that end up on the European Union market, and if your products may be categorised as medical, you need to be very clear about that.
As we discussed recently, the companies involved in manufacturing and getting medical devices to the EU market face very specific responsibilities due to the EU MDR changes that have taken effect in mid-2021.

Let’s look at what EU Medical Device Regulation 2017/745 considers a ‘medical’ product.

Continue reading “EU MDR Changes: Are You Selling a Medical Device, and What Class Is It?”

New EU MDR: Who Are The “Economic Operators” For Imported Devices?

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New EU MDR: Who Are the “Economic Operators” for Imported Devices?Since May 2021, the New EU MDR Medical Device Regulation 2017/745 is in place. One of its objectives has been improving the safety of users and patients. And one way to achieve that objective is ensuring that all the parties involved in the supply chain have clear roles and responsibilities.

In this article, we break down what each “economic operator” is responsible for.

Continue reading “New EU MDR: Who Are The “Economic Operators” For Imported Devices?”

How The EU MDR Will Change The Medical Device Industry Forever [Podcast]

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eu mdr compliance future podcast

Our CEO Renaud is joined again by Clive Greenwood, a China-based product compliance expert, to discuss the new EU MDR.
We all heard about the Wild West of PPE imports in the early days of the pandemic where worrying amounts of substandard PPE was imported into countries desperate for supplies, even though they provided dubious protection against infection. As you’ll hear, the new MDR makes manufacturers and importers accountable for what they bring in and will allow authorities to find, enforce, and prosecute infractions more easily.

So, let’s get into how this new compliance standard for medical devices could affect you today and how it’s set to form a template for future standards.

 

Listen here! 👇👇👇

🎧 Clive Greenwood | What Does The EU Medical Device Regulation Tell Us About Compliance’s Future? Be Afraid! 🎧

▶️ Watch on YouTube ▶️

Here’s what’s included in the episode…

✅ What the Medical Device Regulation (EU) 2017/745 (MDR) is.
✅ If you import medical devices into the EU and have a CE certificate granted under the old MDD, when do you have to switch and will it be an easy transition?
✅ The Scope of the MDR
✅ Why customs will now more easily be able to check the medical devices are compliant
✅ What information about your QMS and processes should be included in the technical document pack
✅ Notified bodies now have to take more action to monitor ongoing production after certification.
✅ Who’s liable now if there is any trouble with the products?
✅ What happens if it’s found that a fake document was submitted or a problem was found?
✅ How can companies transition from the old MDD to the new MDR?
✅ What if you’re planning to bring a medical device to the market soon?
✅ Overall, why is the EU MDR beneficial?
…and much more!

 

A disclaimer…

We at Sofeast are not lawyers. What we discussed above is based only on our understanding of the regulatory requirements. We do not present this information as a basis for you to make decisions, and we do not accept any liability if you do so. Please consult a lawyer before taking action.

 

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