New regulations on medical devices are introduced, and special customized devices have high requirements

According to the official website of the State Food and Drug Administration, in order to meet the rare and special personalized needs in clinical practice, standardize the supervision and management of customized medical devices, and ensure the safety and effectiveness of customized medical devices, the National Medical Products Administration and the National Health Commission jointly issued the "Notice on the Issuance of the <Regulations on the Supervision and Management of Customized Medical Devices (Trial)>" (hereinafter referred to as the "Regulations").

The "Regulations" are divided into six chapters, including general principles, filing management, design and processing, use management, supervision and management, and supplementary provisions, with a total of 35 articles, which clarify the definition, filing, design, processing, use, supervision and management of customized medical devices.

Definition of personalized medical devices

Personalized medical devices refer to medical devices designed and manufactured by medical device manufacturers according to the clinical needs proposed by authorized medical personnel of medical institutions to meet the personalized requirements of patients when the products already on the market in China cannot meet the clinical needs. They are divided into customized medical devices and patient-matched medical devices.

Therefore, customized medical devices have the following characteristics:

First, they are used to diagnose and treat rare and special lesions. The expected number of users is very small, and there are not enough population samples to conduct clinical trials; second, the products already on the market in my country are difficult to meet clinical needs; third, they are proposed by clinicians and designed and produced to meet special clinical needs; fourth, they are used for a specific patient and are expected to improve the diagnosis and treatment effect.

Therefore, patient-matched medical devices can essentially be regarded as specific specifications and models of standardized products.

At the same time, their design and production must be kept within the verified and confirmed range, and used for patient populations that can be clinically studied. Such as customized dentures, hard gas permeable contact lenses for corneal reshaping, orthopedic surgical guides, etc. Patient-matched medical devices should be registered or filed in accordance with the provisions of the "Medical Device Registration Management Measures" and the "In Vitro Diagnostic Reagent Registration Management Measures", and the registered/filed product specifications and models are all possible production size ranges.