Medical Devices 101 | Your Questions | July 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: Are medical devices in scope of Vermont (USA): Regulating Consumer Products Containing Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS) and Other Chemicals, Senate Bill 25 Enacted?

Medical devices are not within the scope of the restrictions of this Vermont legislation.

This complex Bill – Senate Bill 25 Enacted, now Statute – at § 2494e. DEFINITIONS Sec. (8)(B), declares that Medical Devices are exempt from the definition of “Juvenile Products” used in the text. This indicates that devices that are medical are not subject to the restrictions and prohibitions that apply to other products.

However, this state bill requires the Agency of Natural Resources, the Agency of Agriculture, Food and Markets; the Department of Health; and the Office of the Attorney General to determine whether “a drug, medical device, or dietary supplement” are property regulated. The Agencies are then, under this Section, to report to the Legislature and other Agencies with an “implementation plan” by November 1, 2024. This requirement, if it is fulfilled, may at some point have an effect on the regulation of medical devices and drugs.
(at Sec. 9. IMPLEMENTATION PLAN; CONSUMER PRODUCTS CONTAINING PFAS).

Question 2: In China, under the Restriction of the Use of Hazardous Substances in Electrical and Electronic Products, do medical device companies need to label only when a substance is present?

The Ministry of Industry and Information Technology is working on a project for the formulation of a single mandatory standard on the requirements for certain restricted substances in electrical and electronic products, which would combine Standards SJ/T 11364 and Standard GB/T 26572.

The most recent proposal indicates that producers would not need to list products in the table in instances where they did not contain restricted substances, however the official publication of the unified single mandatory standard is not yet published.

Question 3: Are there any exemptions for prohibition of PFOS under China: Catalogue of Goods Prohibited from Import (9th Batch) and Catalogue of Goods Prohibited from Export (8th Batch), Announcement No. 63, 2023?

According to this Announcement, for laboratory-scale research or as reference standards, the relevant import and export prohibition requirements of this catalogue, including PFOS, are not applicable.

Stay Compliant With Global Medical Device Regulations:

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

• Medical Devices Regulatory Updates in North, Central and South America
• Medical Device Regulation Checklist: Brazil
• Regulatory Trends in Medical Devices: A 12-18 Month Outlook
• Software As A Medical Device – Definition and Classification in the EU, USA, China, and Japan
• European Union (EU) In Vitro Diagnostic Regulation 2017/746 (IVDR) and Cybersecurity

Have you got a Medical Device related query?

Many of the Medical Devices 101 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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