Medical device salesperson reporting procedure guide

Purpose:

The Ministry of Health, Welfare and Family Affairs has announced a revised regulation for promoting medical devices, which includes mandatory reporting requirements for businesses engaged in promotional activities related to medical devices. The purpose of this revision is to strengthen the management of medical device promotion and distribution, ensuring that businesses comply with regulatory standards.

Effects on Industry:

The revised regulation affects all businesses involved in promoting medical devices, as they must now report their promotional activities to the relevant health centers. This includes establishing a clear understanding of promotional requirements and procedures, which will impact businesses’ operational processes and resource allocation. Non-compliance with reporting requirements can result in penalties or fines. The long-term effect is expected to be a more regulated and transparent market for medical devices, ensuring consumer safety and protection.

Relevant Stakeholders:

This revised regulation primarily affects businesses engaged in promoting medical devices, such as manufacturers, distributors, and retailers of these products. These stakeholders must now adhere to reporting requirements and undergo compliance training provided by the Korea Medical Device Industry Association Compliance Education Center. Additionally, consumers may also benefit from this revision, as it ensures that promotional activities are conducted responsibly and transparently.

Next Steps:

Businesses involved in promoting medical devices should take immediate action to comply with the revised regulation. This includes:

• • Registering their business and obtaining the necessary certification

• • Undergoing compliance training provided by the Korea Medical Device Industry Association Compliance Education Center

• • Reporting promotional activities to the relevant health centers

• • Adhering to the revised regulations regarding promotional procedures, reporting requirements, and education content

Any Other Relevant Information:

The revised regulation also includes provisions for businesses involved in promoting medical devices. These include:

• • Upgrading their operational processes to meet regulatory standards

• • Allocating resources effectively to manage reporting requirements and compliance training

• • Ensuring that promotional activities are conducted transparently and responsibly, protecting consumer interests