[Situation and suggestions on IVD industrial standards]

Area of Science:

• Biomedical Engineering
• Regulatory Science
• Quality Management

Background:

• Industrial standards are crucial for the safety and efficacy of in vitro diagnostic (IVD) products.
• Effective production and regulatory supervision rely on robust professional standards.
• The development of IVD standards requires a systematic and collaborative approach.

Purpose of the Study:

• To introduce the working procedures for in vitro diagnostic (IVD) product industrial standards.
• To emphasize the significance of professional standards in IVD manufacturing and oversight.
• To identify challenges and propose solutions for enhancing the IVD standards development process.

Main Methods:

• Review of the working procedures for IVD industrial standards.
• Analysis of the progress in IVD standard development over the past 10 years.
• Identification of problems and formulation of countermeasures related to project setting, participation, standard materials, personnel training, and work cycles.

Main Results:

• Key aspects of the IVD industrial standards working procedure are detailed.
• The importance of professional standards for IVD production and supervision is underscored.
• Specific issues in project setting, participation, standard materials, personnel training, and work cycles were identified.

Conclusions:

• Addressing identified problems in project setting, participation, standard materials, personnel training, and work cycles is essential.
• The proposed countermeasures offer a roadmap for the future development of IVD standards.
• Continuous improvement in the IVD standards framework will support the advancement of the IVD industry.