Medical device product explanation meeting related medical device act amendment reflection legal review
Article posted in 2024-03-08 14:50:53 | VEAT
Law firm Veat received a request from medical device startup A (hereinafter referred to as the "client") regarding legal review of questions related to the medical device product description meeting.
The Medical Device Act and Fair Competition Ordinance generally prohibit providing economic benefits to promote the sale or rental of medical devices. In this regard, Law firm Veat’s Startup Consulting Team provided the client with detailed guidance on the specific criteria and exceptions they must comply with.
CSOs (Contract Sales Organizations) must comply with the regulations stipulated in the Medical Device Act and Fair Competition Ordinance. Law firm Veat’s Startup Consulting Team helped the client, a medical device startup, understand the scope of economic benefits that medical device sales or rental agents can provide and provided advice necessary to manage legal risks.
The amended "Medical Device Act," revised on August 8, 2023, and scheduled to take effect on February 9, 2025, includes new definitions for medical device promotional agents, reporting obligations, compliance with reporting and education, and prohibited regulations. Law firm Veat Startup Consulting Team provided detailed guidance on the main contents of the amended Act and what medical device-related companies must comply with, and carefully addressed the legal issues needed during the preparation process.
Reporting obligations and compliance requirements as a medical device promotional agent pursuant to the Medical Device Act amended on 2023.08.08
Medical device startups must comply with product certification and approval procedures and establish manufacturing and quality management systems. Compliance with medical device-related regulations, including GMP certification, is an important factor in product development and promotional activities. In addition, reporting obligations and compliance requirements for medical device promotional agents have been newly introduced in accordance with the Medical Device Act amended on 2023.08.08.
Article 6, Paragraph 4 of the Medical Device Act stipulates: “A person who seeks a manufacturing license pursuant to paragraph 1, and a person who seeks a manufacturing license or manufacturing certification, or makes a manufacturing notification pursuant to paragraph 2, shall prepare the necessary facilities and manufacturing and quality management system in advance in accordance with the total prime minister’s ordinance and apply for or notify the license or certification. However, this shall not apply in cases where quality control tests or manufacturing processes are entrusted in accordance with the total prime minister’s ordinance.”
The amended Medical Device Act regulations define the contents that manufacturing license and notification should review in advance, change permit, obligations of manufacturers, and spending reports regarding the provision of economic benefits, etc., that promotional agents and medical device companies must do, so we recommend that you prepare in advance in accordance with the Medical Device Act amendment that will take effect on February 9, 2025, which is not currently applicable to the Medical Device Act.
For medical device-related startups, it is important to undergo a complex GMP certification and other professional legal review processes related to medical devices. In particular, when holding a medical device product description meeting, it is essential to carefully review with legal experts with extensive experience in bio/healthcare legal consultation to ensure compliance with the Medical Device Act and related regulations.
If you need legal advice related to medical devices and other bio/healthcare matters, please contact Law firm Veat. Thank you. Law firm Veat