National Food and Drug Administration: Important medical device documents issued

1

All cities involved

On March 30, the National Medical Products Administration and the National Standardization Administration issued the "Opinions on Further Promoting the High-Quality Development of Medical Device Standardization".

The key points of Cyber ​​Blue Equipment are as follows:

▍Key 1: By 2025, my country will basically establish a full life cycle system for medical devices

The document pointed out that by 2025, it will be basically completed to meet my country's medical device development, production, operation, use, supervision and management needs for the entire life cycle management, meet the new requirements of strictly abiding by the safety bottom line and boost the quality and high line, and be in line with international standards and have Chinese characteristics.

▍Key 2: Comprehensive evaluation of mandatory medical device standards

Research and formulate general principles and basic requirements for the construction of the standard system, rationally plan the layout of the standard system, and scientifically formulate standard plans around the major deployment of medical device supervision and industrial development.

▍Key 3: Encourage the development and revision of recommended industry standards in emerging technology fields and urgently needed by supervision

Optimizing recommended standards, focusing on supporting the formulation and revision of recommended national standards that are basic and common, supporting compulsory national standards, and leading the industry; encourage the formulation and revision of recommended industry standards in emerging technology fields and urgently needed by supervision.

Improve medical device terminology definitions, marking and identification, risk management, quality management, clinical evaluation management, usability engineering, statistical technology, digital security and other basic standards covering the entire life cycle of medical devices.

▍Key 4: Active medical devices will focus on

Strengthen the development of active medical device standards.

Improve medical respiratory and anesthesia equipment, disinfection and sterilization equipment, oral digital equipment, medical body circulation equipment, radiotherapy and nuclear medicine equipment, medical ultrasound equipment, physical therapy equipment, medical laboratory equipment, medical X-ray diagnostic equipment, and medical laser equipment , Medical radio frequency equipment and other high-end medical equipment related standards.

▍Key 5: Strengthen the development of passive medical device standards

Strengthen the development of standards for passive medical devices.

Establish a standard system for preclinical animal testing.

▍Key 6: Strengthen the development of in vitro diagnostic reagent standards

Accelerate the development of standards for diagnostic reagents and related methods for high-risk infectious diseases, and carry out research on in vitro diagnostic reagent standards related to the prevention and control of the new crown pneumonia epidemic.

2

The new "Regulations" will be formally implemented soon

A few days ago, the State Council Information Office held a regular policy briefing to introduce the "Regulations on the Supervision and Administration of Medical Devices" (hereinafter referred to as the "Regulations").

According to Xu Jinghe, deputy director of the State Drug Administration, the biggest features of the Regulations can be summarized in four words: one is "new", adding many new systems, new mechanisms, and new methods to improve governance; the second is "excellent".

▍Key 1: Pilot medical device registrant system, covering 22 provincial-level regions

Beginning in 2018, the State Food and Drug Administration launched a pilot program for the medical device registrant system, and the scope of the pilot program has reached 22 provinces, autonomous regions, and municipalities directly under the Central Government.

▍Key 2: Announcement of the number of national medical device manufacturers and operating companies

According to data released by the State Food and Drug Administration, there are currently more than 25,000 medical device manufacturers and more than 897,000 operating companies across the country.

The number of national medical device registration certificates reached 139,000, the number of registered medical devices reached 115,000, and the number of innovative medical devices approved for marketing reached 103.

▍Key 3: Prioritize review and approval of innovative medical devices

According to Wang Zhenjiang, director of the Legislative Third Bureau of the Ministry of Justice, three aspects have been focused on during the revision of the Regulations: First, encourage innovation and promote high-quality industrial development.

▍Key 4: Step by step implementation of the unique identification system for medical devices, giving "electronic ID cards"

Scientific supervision, promote the modernization of the supervision system and supervision capabilities.
The "Regulations" further enriched the supervision methods and stipulated extended inspection measures.
When necessary, relevant units that provide products or services for the development, production, operation, and use of medical devices can be inspected, which further reflects the full supervision of medical devices.
It stipulates the step-by-step implementation of a unique identification system for medical devices, assigning "electronic ID cards" to medical devices, and strengthening the management of the entire life cycle from source production to clinical application.

▍Key 5: Quality problems, a fine of up to 30 times the value of the goods can be imposed

Increase the cost of violations and severely punish violations.
The "Regulations" set different levels of penalties according to the degree of social harm of illegal acts.
For illegal acts involving quality and safety, a fine of up to 30 times the value of the goods can be imposed.
Increase the "Punishment to Person" measures, and impose punishments such as confiscation of income, fines, and prohibition of related activities for five years to lifelong on relevant responsible personnel of units that seriously violate the law.

▍Key 6: Simplify and optimize the clinical evaluation system for medical devices

The new "Regulations" made the following provisions on the clinical evaluation system: First, for non-clinical evaluations that can prove safe and effective, they are exempt from clinical evaluations.
The second is to carry out clinical evaluation can take the following paths, including carrying out clinical trials, through the analysis and evaluation of the clinical literature and clinical data of the same variety of medical devices.
The third is that when the clinical evaluation of medical devices is carried out further, the clinical literature and clinical data are not enough to confirm the product safety and effective medical devices, and clinical trials should be carried out.
The fourth is to optimize the clinical trial review procedures, and the implementation of clinical trials has been changed from "express permission" to "implicit permission" in the past.

In the current practice of medical device review and approval, only about 12.
5% ​​of the entire review is required for clinical trials; about 42.
5% for other clinical evaluations; and about 42.
5% of those that are exempted from clinical evaluations Accounted for 45%.
The reform of this classified management system is conducive to further saving resources, improving efficiency, encouraging innovation, and better meeting the public's need for machinery.