Medical Devices 101 | Your Questions | October 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 our Medical Devices 101 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 exempted in South Korea Draft Notice No. 2024-605 on Recycling of Electrical and Electronic Equipment?

Article 8 of South Korea Enforcement Ordinance on the Recycling of Electrical and Electronic Equipment and Vehicles Draft Notice No. 2024-605 states that the exemption applies to “Electrical and electronic products corresponding to medical devices manufactured or imported by a person who has obtained a manufacturing or import business license pursuant to Article 6 or Article 15 of the Medical Devices Act.”

This draft amendment proposes to change the wording in this exemption to:

“Medical devices expected to be infectious as prescribed by the Minister of Environment and announced”. The Minister will determine the list of products that fall under this exemption through an announcement. Similar wording is proposed to be added as an exemption from Article 14 regarding electrical and electronic products subject to collection, transfer, and recycling obligations.

Question 2: Are there any new cybersecurity requirements in Japan that require specific certifications or documentation for the registration of products or medical devices?

Japan has not enacted mandatory cybersecurity requirements for products but they are developing a voluntary cybersecurity certifications scheme for Internet of Things (IoT) devices. Please refer to Japan’s IoT Product Security Conformity Assessment Scheme, Policy, August 2024. This Scheme applies to IoT devices that have the ability to send and receive data using Internet Protocol (IP), including devices that can be connected to the Internet or a network.  However, it will not cover general-purpose IT products such as PCs, tablets, smartphones and etc. The Scheme will initially be operated as a voluntary scheme. By making this mandatory in the future, IoT product vendors will be given incentives to acquire labels.

In relation to medical devices registration, please refer to Japan’s Standards for Medical Devices under Article 41 (3) of Pharmaceutical Affairs Act, Notice No. 122, 2005  Amendment on cybersecurity of medical devices Notice No. 67, 2023″. This added Clause 3 on cybersecurity requirements to Article 12 of the Essential Principles criteria. Medical devices using programs are now required to ensure safety and basic performance by implementing risk management throughout the medical device software life cycle. In addition, medical devices connected to other IT devices and medical devices connected to the Internet are now required to comply with JIS T 81001-5-1 to reduce cybersecurity risks to acceptable levels.

Question 3: What is the scope of France Decree 2022-748 on Consumer Information on the Environmental Qualities and Characteristics of Waste-generating Products, are medical devices sold only to professional users outside the scope of this regulation?

Decree 2022-748 aims to enhance sustainability and reduce waste in various sectors, particularly focusing on product labeling and consumer information regarding sustainability and recyclability. It focuses on products meant for private households (B2C) rather than for professionals.

Stay Compliant With Global Medical Device Regulations:

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

• Stay Compliant: Medical Device Industry 2024 Regulatory Update
• 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

Medical Devices 101: 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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