Overview of the main requirements for medical device design control in the three major markets: FDA, EU and China

Design Control in medical device development refers to a series of organized and planned management and technical activities that ensure the product meets predefined performance requirements, safety, effectiveness, and regulatory requirements throughout the design and production phases.

Design control plays a crucial role in the quality management system for medical devices, especially when ensuring compliance with standards and regulations such as the FDA (U.S. Food and Drug Administration), EU MDR (Medical Device Regulation),NMPA GMP and ISO 13485.

FDA (U.S. Food and Drug Administration):

Current good manufacturing practice (CGMP) requirements are set forth in this quality system regulation. 

The requirements in this part govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use. 

The requirements in this part are intended to ensure that finished devices will be safe and effective and otherwise in compliance with the Federal Food, Drug, and Cosmetic Act (the act). 

EU MDR (Medical Device Regulation):

REGULATION (EU) 2017/745

When placing their devices on the market or putting them into service, manufacturers shall ensure that they have been designed and manufactured in accordance with the requirements of this Regulation.

China NMPA GMP：

Regulations on the Supervision and Administration of Medical Devices

Article 2 These Regulations shall apply to the development, production, operation, use and supervision and administration of medical devices within the territory of the People's Republic of China.

Article 13 Product filing management shall be implemented for Class I medical devices, and product registration management shall be implemented for Class II and Class III medical devices.

Registrants and registrants of medical devices shall strengthen the quality management of the entire life cycle of medical devices, and shall bear legal responsibility for the safety and effectiveness of medical devices throughout the entire process of development, production, operation and use.

Medical Device Production Quality Management Standards

Article 2 Medical device manufacturers (hereinafter referred to as enterprises) shall comply with the requirements of these standards in the process of design, development, production, sales and after-sales service of medical devices. For details on design control, please refer to Chapter 6 Design and Development