Medical Devices 101 | Your Questions | February 2024

Medical devices face a unique regulatory landscape that has been increasingly complicated by several factors in recent years.

The demand for more sustainable technology is being driven by both consumer demand and legislators, leading to regulatory implications. Global events such as Brexit and COVID-19 have also created unprecedented challenges.

As devices become increasingly integrated with artificial intelligence and an internet connection, new cybersecurity and data protection legislation is racing to keep up.

And on top of all this, the new regulatory framework for IVDR and proposed amendments for the registration, and inspection of medical devices under MDR means staying ahead is more critical than ever.

In this series, we gather some of the most interesting recent inquiries from Compliance & Risks customers regarding medical device regulatory updates globally.

Question 1: Do any exemptions apply to medical devices per the draft Regulation from California on the Implementation of Plastic Pollution Prevention and Packaging Producer Responsibility Act?

The exemptions listed in California draft regulation on the Implementation of Plastic Pollution Prevention and Packaging Producer Responsibility Act include;

• (1) Packaging used for products described in section 42041(e)(2)(A)(i) of the Public Resources Code as “medical products and products defined as devices or prescription drugs,” which means the following products:
  • (A) “Drugs,” as defined under section 321(g) of Title 21 of the United States Code.
  • (B) “Medical devices,” as defined by section 321(h) of Title 21 of the United States Code.
  • (C) “Prescription drugs,” as defined by section 353(b)(1) of Title 21 of the United States Code.

Question 2: What is the scope of Shanghai (China) regulation on New Pollutants under Key Control, Order No. 27, 2023?

Per Shanghai (China): New Pollutants under Key Control (2023 Edition), Order No. 27, 2023, Perfluorooctanoic acid, its salts and related compounds (PFOA) are listed as a new pollutant. According to the order, Production, processing and use are prohibited (except for the following uses);

1. Photolithography or etching processes in semiconductor manufacturing;
2. Photographic coatings for film;
3. Protecting workers from health and safety risks posed by hazardous liquids, Oil- and water-repellent textiles;
4. Invasive and implantable medical devices;
5. Use of perfluorooctane to produce perfluorooctane for pharmaceutical production purposes.

The order states that enterprises that use PFOA for the above purposes should implement mandatory cleaner production audits in accordance with the law and that if you import or export PFOA and are included in China’s list of strictly restricted toxic chemicals, you must apply for a toxic chemicals import (export) environmental management release notice. It is also prohibited to build new PFOA production equipment.

Question 3: Are medical devices in scope of the New Zealand order 2023/234 (Imports and Exports (Restrictions) Prohibition Order (No 2) 2004 Amendment Order 2023)?

The effect of this Order applies to PFOA and PFOA-related compounds as substances rather than PFOA in articles. At the Conference of the Parties (COP) in June 2022, parties agreed to list PFOA, its salts and PFOA-related compounds and decaBDE in Annex III of the Convention.

This decision means that export of PFOA, its salts and PFOA-related compounds, and decaBDE, are subject to a PIC procedure. These listings entered into force globally on 22 October 2022. Order 2023/234 implements the effect of these listings in New Zealand legislation amending Schedule 2 of the Imports and Exports Order to add PFOA, its salts and PFOA-related compounds, and decaBDE.

Stay Compliant With Global Medical Device Regulations:

Catch up on our medical device updates with your coffee here:

• Software As A Medical Device – Definition and Classification in the EU, USA, China, and Japan
• Regulatory Trends in Medical Devices: A 12-18 Month Outlook
• Keeping Pace with Change: Recent Regulatory Updates Shaping Medical Device Compliance
• European Commission Publishes MDR and IVDR Factsheet for Non-EU/EEA Countries

Have you got a Medical Device related query?

Many of the above questions were submitted and answers were conveyed by Compliance & Risks customers via the “Ask Our Experts” button in C2P. 

Clients use AOE to ask about the latest proposed, enacted, and amended regulations and mandatory standards applicable to their products and geographies of interest. 

When AOE questions can be answered in 30 minutes or less, Compliance & Risks’ subject matter experts answer them at no charge!

To learn more about C2P and how Compliance & Risks SMEs can help you with your questions, contact us today.

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