Medical equipment standards are technical documents that need to be complied with in the production, operation and use of the whole life cycle of medical device, and one of the important signs of the development level of the medical device industry. Actively participating in international standardization of medical device is the only way for the development and international development and internationalness of my country's medical device industry, and it is also an important manifestation of the influence of the standard influence of medical device in my country. In recent years, especially in 2021, the international standardization of medical devices in my country has made major breakthroughs.
Leading international standards for the formulation of epidemic prevention and control equipment
At the beginning of 2020, after the epidemic of new coronary pneumonia, high -flow respiratory therapy equipment became one of the important medical equipment for patients to treat patients, and the demand was explosive. For a while, many manufacturers were put into operation, but at that time there were no special standards for such products at home and abroad.
In order to regulate production and ensure the safety of patients' use of weapon, my country immediately organizes the national anesthesia and respiratory equipment standardization technical committee (SAC/TC116) to convene relevant domestic experts to set up a project team to investigate the high -flow respiratory treatment equipment in clinical use during the epidemic situation. Specific problems, safety protection scenarios that may be involved; based on international standardization work experience in the field of breathing anesthesia, combined with the research on international standard systems and industrial development, in March 2020, ISO/TC121 (international standardized organization/anesthesia and breathing equipment standardization Technical Committee) Application for formulating new international standards for high -flow respiratory treatment equipment for high -flow respiratory treatment equipment. In June of the same year, the International Standardized Organization (ISO) and the International Electricity Commission (IEC) each passed the new project with a high approval rate, respectively, as the convener of the project team. SAC/TC116 carefully organized, actively promoted, drafted standards, and organized 5 international work group meetings to discuss standard text through ISO/TC121/SC3 Secretariat.
It takes only 14 months to release it, 10 months earlier than the original plan. This standard is the first international standard project of the new crown pneumonia's epidemic prevention and control medical device proposed by my country, which fills the blank of international standards for such products, further improves the international standard system in the field of anesthesia and breathing equipment. The safety and effective treatment of equipment and promotion of international circulation have played a positive role, providing technical support for the global epidemic prevention and control, and contributing Chinese wisdom. The release of this standard not only reflects the recognition of international standards formulated by the International Standardized Organization, but also reflects the improvement of my country's medical device technology innovation capabilities.
my country's device industry standards have completed international transformation for the first time
Cardiac block is used to treat blood vessel interventional medical devices with congenital heart disease such as heart room septal defects and ventricular septal defects. In recent years, domestic cardiac blocks have dominated in the domestic market and gradually entered the international market.
In order to better regulate and promote the development of the heart blocking device industry, the drug regulatory department in my country released YY/T 1553-2017 "Cardiovascular Plane Consulture" in 2017. In the same year, my country filed an application for ISO to transform this standard into international standards. The application was approved and approved by the 2017 annual meeting of the International Standardized Organization/Surgical Plant Intriplative Equipment and Improving Device Standardization Technical Committee (ISO/TC150). In March 2021, during the voting phase of the International Standard (DIS), the draft standard was fully voted and did not receive technical modification opinions. It reflects the recognition of each member's technical indicators.
In November 2021, the first international standard ISO 22679-2021 "Cardiovascular implantation-heart blocking device\\ my country has played a leading role in the formulation of this international standard, demonstrating my country's technical characteristics and regulatory advantages in the field of heart blocking device products, and accumulated work experience for my country's medical device industry standards.
my country's dominant international standard projects are continuously increasing
After the accumulation and efforts in recent years, the international standardization of medical device in my country has continued to develop in depth. In 2021, in addition to the two international standards of the "Special Requirements for Basic Safety and Basic Performance of High Dental Respiratory Treatment Equipment\\ , "Part 15 of the Medical Insteadr: Disposal Using Lights Diseases\\ The international standards enter the corresponding stage as planned. In addition, my country has also proposed the "Energy Imaging Performance Evaluation Method of Computer Body Photography Equipment\\
The international standardization work of my country's medical device is gradually completing the role change from "learners" to "participants" to "leaders". The research results of standardization of medical devices shared with other countries and regions to expand the influence of medical device standards in my country; at the same time, the theory and methods of international standards were used to guide the construction of my country's medical device standard system to achieve standardized "win -win cooperation".
For the first time and undertake the new IMDRF standard project
In order to thoroughly study the international standards of medical device in various countries and regions, under the leadership of the State Drug Administration, the State Drug Administration's Medical Device Standard Management Center (hereinafter referred to as the standard management center) represents my country New work project (I MDRF )- "Update the International Standard List recognized by I MDRF members in 2014". The project passed at the 13th management committee meeting held in March 2018 and was approved by the joint chairman of the IMDRF Standard Working Group. The project has realized the historic breakthroughs of my country from participating in the development of international standards for leading medical devices. It is a new progress in my country's continuous and in -depth promotion of medical device standards management experience.
During the project, the standard management center actively played the role of joint chairman, and organized a working group to study the relevant policies of the international standards of IMDRF's recognition of the IMDRF members and the use of standards for medical device regulators. In September 2019, the project research results "Analysis Report on Standards and Usage" and "IMDRF Member Acknowledged International Standard List" passed on the 16th management committee of IMDRF. The project's comprehensive study of policies and regulations, procedures, and specific standards that members of the IMDRF members recognize international standards have an important role in promoting the development of global medical device supervision and convergence. At the same time, my country has also actively participated in the drafting of IMDRF's "Standards used by Optimization of Medical Device Supervision" guidelines, promoting my country's medical device standard management experience, and striving to enhance the influence and discourse rights of international standardization of medical device in my country.
In 2021, the international standardization of medical devices in my country has achieved gratifying results. In the next step, it is necessary to accelerate the cultivation of talents in international standardization and improve the enthusiasm of enterprises to participate in international standardization. Explore my country's independently formulated medical device standards to the international, and make greater contributions to improving the level of international standardization of medical device in my country.
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