The State Food and Drug Administration recently issued a notice that the 2021 “National Medical Device Safety Publicity Week” will be held from the 19th to the 23rd of this month, aiming to promote innovation and high-quality development of the medical device industry, popularize knowledge on the safe use of medical devices, and better meet public health needs. It is reported that this “National Medical Device Safety Publicity Week” with the theme of “Safe Device Use, Innovation and Development” will focus on four aspects: displaying the achievements of medical devices in the century since the founding of the Party, publicizing and implementing the “Regulations on the Supervision and Administration of Medical Devices” and its supporting regulations, promoting technological innovation and high-quality development of medical devices, and carrying out popularization of medical device knowledge.
The event will combine online and offline publicity, linkage between national and provincial drug regulatory authorities, and extensive participation from relevant directly affiliated units, industry associations, related enterprises, e-commerce platforms, and the general public to jointly promote the implementation of the “Regulations on the Supervision and Administration of Medical Devices” and its supporting documents, popularize medical device safety knowledge, and bring a unique feast of popular science on medical device safety.
What are the highlights of this year’s National Medical Device Safety Awareness Week? Let’s take a look!
——The launching ceremony of the 2021 “National Medical Device Safety Publicity Week”
On July 19, the launching ceremony of the 2021 “National Medical Device Safety Publicity Week” will be held in Beijing. At that time, relevant departments of the State Council, local governments, industry enterprises, news media, social organizations and representatives from all walks of life will gather together to witness the launch of this publicity week.
——”Wenhuiyuan Salon”——Medical device registration and supervision symposium
The promulgation and implementation of the “Regulations on the Supervision and Administration of Medical Devices” have put forward new requirements for the registration and supervision of medical devices. During the publicity week, the State Food and Drug Administration and provincial regulatory personnel, experts and scholars in the field of medical devices, representatives of medical device industry associations and enterprises will hold discussions to discuss issues such as new systems, new mechanisms, and new methods related to the Regulations to promote the healthy development of the industry.
——Public welfare training of “Regulations on the Supervision and Administration of Medical Devices”
The public welfare training on the “Regulations on the Supervision and Administration of Medical Devices” will be conducted through online live broadcasts for registrants, filers and grassroots regulatory personnel in various provinces. Training will mainly be conducted on the revision of the “Regulations”, the design of the registration management system, and the design of the post-market supervision system.
——Visit the China Medical Device Museum
The China Medical Device Museum plays an important role in displaying the historical achievements of medical devices and promoting the cultural promotion and educational dissemination of medical devices. On July 20, medical device regulators, business representatives, and news media will enter the China Medical Device Museum to gain an in-depth understanding of the little-known moving stories behind the development of my country’s medical device technology and regulatory development, inherit red beliefs, and strengthen ideals and beliefs.
——”Safe weapons into the community” activity
How to measure blood pressure accurately? How to use blood glucose meter correctly? How long does it take for the mask to be replaced? These questions will be answered during the “Safe Weapons in the Community” event. At that time, the event will invite experts to explain to the public the correct use and precautions of common household medical devices. At the same time, publicity materials on medical device adverse events will be distributed to the public, and questions related to medical device adverse events will be answered and consulted.
——Seminar on the comprehensive implementation of the registrant system
The “Regulations on the Supervision and Administration of Medical Devices” fully implements the registrant system. At the seminar, some provincial food and drug administrations, industry associations, and some enterprises will discuss the overall situation of the registrant system pilot, introduce the results achieved after the registrant system pilot in the Yangtze River Delta region, and share experience in implementing the main responsibilities of the product life cycle and promoting industrial innovation and development.
——Medical device production quality management standard experience exchange meeting
In order to further strengthen the supervision and management of medical device production and standardize the quality management of medical device production, the medical device supervision departments of the State Food and Drug Administration and provincial food and drug administrations and 100 companies will jointly communicate and share experiences on issues related to quality management of medical device manufacturers.
——Medical device online sales supervision and publicity
In recent years, online sales of medical devices have received more and more attention. At this publicity week, relevant provincial and municipal regulatory authorities and online platform companies will conduct exchanges and discussions on medical device online sales supervision regulations, policies, and regulatory work, as well as the medical device “net cleanup” operation, the medical device online sales industry situation, and the construction of a medical device online sales monitoring platform.
——Public publicity and implementation of medical device registration methods
On July 21, the State Food and Drug Administration will organize registrants, filers and grassroots regulatory personnel in various provinces to carry out publicity and implementation of medical device registration methods. Promote the drafting background and revision status of the “Medical Device Registration and Management Measures” and “In Vitro Diagnostic Reagents Registration Management Measures”, and interpret the specific provisions.
——Medical device adverse event monitoring symposium
Medical device adverse event monitoring plays an important role in controlling risks. During the publicity week, the State Food and Drug Administration, the Drug Evaluation Center of the State Food and Drug Administration, provincial monitoring agencies, relevant personnel of medical institutions and medical device registrants will hold discussions on the impact of the implementation of the “Medical Device Supervision and Administration Regulations” on the monitoring of medical device adverse events, as well as the next step of monitoring work.
——Medical device inspection work series activities
The series of medical device inspection activities will be carried out in a combination of online and offline activities. The offline event invited experts to give lectures on assisted reproductive products, wearable devices, life support products, nucleic acid testing products, blood screening data analysis, etc., and to visit the laboratory of the Medical Device Testing Institute of the Central Medical Examination Institute. The online event focused on interpreting the “Opinions of the National Standardization Management Committee of the State Food and Drug Administration on Further Promoting the High-Quality Development of Medical Device Standardization Work” and introduced the progress of medical device standards, classification, naming, definition of attributes of drug-device combination products, and ideas for next steps.
——Working meeting to promote capacity building of medical device inspection team
During the publicity week, some provincial inspection agency representatives, inspector representatives, and enterprise representatives will visit the training base, conduct discussions and exchanges, and experience the process of regulatory inspections promoting the development of the medical device industry since the implementation of the Medical Device Production Quality Management Standards. They will understand the establishment and operation of the enterprise’s quality management system at close range, enhance the scientific inspection capabilities of inspectors, improve the level of enterprises in establishing and operating quality management systems, and promote the high-quality development of the medical device industry.
——Medical device science knowledge promotion
The publicity week will also carry out online publicity on popular science knowledge about commonly used medical devices at home. Promote knowledge about the purchase and use of oxygen concentrators and blood oximeters to the public. Help the public understand the importance of medical device supervision in promoting high-quality development of the industry and ensuring the safety of devices used by the public.
——Medical Device Innovation and Development Symposium
The symposium will introduce the progress of supporting the innovative development of medical devices, discuss with enterprises the implementation of innovative medical device policies, understand the difficulties encountered by enterprises, and discuss the next work plan. The symposium aims to encourage the development of the medical device industry and the application of new technologies, promote the transformation and application of scientific achievements, create a high-quality integrated development platform, provide more high-quality services for corporate R&D innovation, and serve the innovative development of the pharmaceutical industry.
——Online sales of medical devices publicity and education activities
How do consumers check seller qualifications? How to purchase qualified products? How to use medical equipment correctly? These questions will be answered through the online publicity and education column for online shopping of medical devices. At the same time, the event will also collaborate offline with communities related to large chain pharmacies to carry out community safety equipment and health education activities, and organize a variety of activities such as expert consultation, popular science displays, and interactive games.