Through the ups and downs of 2023, the cycle of 2024 has officially started. A number of new laws of survival are gradually established, the medical device industry “time for change” has arrived.
In 2024, these changes will take place in the medical industry:
01
From 1 June, 103 kinds of devices “real name” management
In February last year, the State Drug Administration (SDA), the National Health Commission (NHC), and the National Health Insurance Administration (NHIA) issued the “Announcement on the Third Batch of Implementation of Unique Identification of Medical Devices”.
According to the level of risk and regulatory needs, some single-use products with large clinical demand, centralised volume purchasing selected products, medical beauty related products and other Class II medical devices were identified as the third batch of medical devices with unique labelling.
A total of 103 types of medical devices are included in this unique labelling implementation, including ultrasound surgical equipment, laser surgical equipment and accessories, high-frequency/radiofrequency surgical equipment and accessories, active equipment for endoscopic surgery, neurological and cardiovascular surgical instruments – cardiovascular interventional devices, orthopaedic surgical instruments, diagnostic X-ray machines, phototherapy equipment, pacing system analysis equipment, syringe pumps, clinical laboratory instruments and so on.
According to the Announcement, for medical devices included in the third batch of the implementation catalogue, the registrant shall carry out the following work in an orderly manner in accordance with the timeframe requirements:
Medical devices produced from 1 June 2024 shall have the unique marking of medical devices; products previously produced for the third batch of implementation of unique marking may not have unique marking. The date of production shall be based on the medical device label.
If applying for registration from 1 June 2024, the applicant for registration shall submit the product identification of the smallest sales unit of its product in the registration management system; if the registration has been accepted or approved before 1 June 2024, the registrant shall submit the product identification of the smallest sales unit of its product in the registration management system when the product is renewed or changed for registration.
Product identification is not a matter of registration review, and individual changes in product identification do not fall within the scope of registration changes.
For medical devices produced from 1 June 2024, before they are put on the market and sold, the registrant shall upload the product identification of the smallest sales unit, the higher level of packaging and related data to the database of unique identification of medical devices in accordance with the requirements of the relevant standards or specifications, to ensure that the data are true, accurate, complete and traceable.
For medical devices that have maintained information in the classification and code database of medical consumables of the State Medical Insurance Bureau for medical insurance, it is necessary to supplement and improve the classification and code fields of medical consumables of medical insurance in the unique identification database, and at the same time, improve the information related to the unique identification of medical devices in the maintenance of the classification and code database of medical consumables of medical insurance and confirm the consistency of the data with that of the unique identification database of medical devices.
02
May-June, the fourth batch of consumables state procurement results landed on the market
On 30 November last year, the fourth batch of consumables state procurement announced the proposed winning results. Recently, Beijing, Shanxi, Inner Mongolia and other places released the Notice on the Determination of the Agreement Purchasing Volume for the Selected Products in the Centralised Banded Purchasing of Medical Consumables for National Organisations, which requires local medical institutions to determine the agreement purchasing products as well as the purchasing volume.
According to the requirements, the NHPA, together with relevant departments, will guide localities and selected enterprises to do a good job in landing and implementing the selected results, so as to ensure that patients across the country can use the selected products in May-June 2024 after price reductions.
Calculated on the basis of the pre-collected price, the market size of the collected products is about 15.5 billion yuan, including 6.5 billion yuan for 11 varieties of IOL consumables and 9 billion yuan for 19 varieties of sports medicine consumables. With the implementation of the collected price, it will further stimulate the expansion of the market scale of IOL and sports medicine.
03
May-June, 32 + 29 provinces consumables collection results implementation
On 15 January, Zhejiang Medical Insurance Bureau issued the Notice on the Announcement of the Selection Results of the Interprovincial Union’s Centralised Banded Purchasing of Coronary Intravascular Ultrasound Diagnostic Catheters and Infusion Pumps. The centralised banded purchasing cycle for both types of consumables is 3 years, calculated from the actual implementation date of the selected results in the alliance area. The first year’s agreed purchasing volume will be implemented from May-June 2024, and the specific implementation date will be determined by the alliance region.
The two types of consumables collection and procurement led by Zhejiang this time cover 32 and 29 provinces respectively.
According to the official website of Zhejiang Medical Insurance Bureau, there are 67 enterprises actively participating in this alliance procurement site, the average reduction of coronary intravascular ultrasound diagnostic catheter collection compared with the historical price of about 53%, the alliance area annual savings of nearly 1.3 billion yuan; infusion pump collection compared with the historical price of an average reduction of about 76%, the alliance area annual savings of nearly 6.66 billion yuan.
04
Medical anti-corruption continues with heavier penalties for medical bribery
On July 21 last year, according to the official website of the National Health Commission, the deployment of a one-year national pharmaceutical field corruption issues focused on rectification work. 28 July, the discipline inspection and supervision organs to cooperate with the national pharmaceutical field corruption issues focused on rectification work mobilisation and deployment video conference was held, put forward to in-depth development of the pharmaceutical industry in the whole field, the whole chain, the whole coverage of the systematic governance.
Currently there are five months to go before the end of the centralised rectification work.2023 In the second half of the year, the pharmaceutical anti-corruption storm swept across the country at high pressure, creating an extremely strong impact on the industry. Since the beginning of the year, the state multi-departmental meeting mentioned pharmaceutical anti-corruption, anti-corruption granularity will continue to escalate in the new year.
On 29 December last year, the seventh meeting of the Standing Committee of the Fourteenth National People’s Congress adopted the “Amendments to the Criminal Law of the People’s Republic of China (XII)”, which will come into force from 1 March 2024 onwards.
The amendment explicitly increases criminal liability for some serious bribery situations. Article 390 of the Criminal Law was amended to read: “Anyone who commits the offence of active bribery shall be sentenced to fixed-term imprisonment of not more than three years or criminal detention, and shall be fined; if the circumstances are serious and the bribe is used to obtain an undue advantage, or if the national interest suffers a significant loss, he shall be sentenced to fixed-term imprisonment of not less than three years but not more than ten years, and shall be fined; if the circumstances are particularly serious or if the national interest suffers a significant loss, he shall be sentenced to fixed-term imprisonment of not less than ten years or life imprisonment. more than ten years’ fixed-term imprisonment or life imprisonment, and a fine or confiscation of property.”
The amendment mentions that those who pay bribes in the areas of ecological environment, financial and fiscal affairs, safety production, food and drugs, disaster prevention and relief, social security, education and medical care, etc., and who carry out illegal and criminal activities will be given heavier penalties.
05
National Inspection of Large Hospitals Launched
At the end of last year, the National Health Commission issued the Large Hospital Inspection Work Programme (Year 2023-2026). In principle, the scope of this inspection is for public hospitals (including Chinese medicine hospitals) of level 2 (with reference to level 2 management) and above. Socially-run hospitals are implemented with reference in accordance with the management principles.
The National Health and Wellness Commission is responsible for the inspection of hospitals under the Commission (management) and for inspecting and guiding the inspection of hospitals in each province. Provinces, autonomous regions, municipalities directly under the Central Government and Xinjiang Production and Construction Corps Health Commission in accordance with the principle of territorial management, unified organisation and hierarchical responsibility, to carry out hospital inspection work in a planned and step-by-step manner.
In January this year, for the second level (with reference to the second level of management) and above public Chinese medicine hospitals (including Chinese and Western medicine combined hospitals and ethnic minority medical hospitals) has been initiated, Sichuan, Hebei and other provinces have also issued a letter, one after another, to start the inspection of large hospitals.
Focused inspection:
1. Whether to develop and implement the centralised rectification work, the “nine guidelines” and the action plan for clean practice of specific measures to improve the practical, targeted, easy to operate rules and regulations, and the establishment of a long-term mechanism.
2. Whether the centralised rectification work has achieved the “six in place” of ideological initiation, self-examination and self-correction, transfer of clues, verification of problems, organisational handling and establishment of mechanisms. Whether to strengthen the supervision of the “key minority” and key positions. Whether to adhere to the principles of “punish to prevent, treat to save, reflect strict control and love, leniency and strictness, and accurately use the “four forms” to carry out the work.
3. Whether to strengthen the supervision of accepting commercial commissions, participating in fraudulent insurance fraud, over-diagnosis and treatment, illegally accepting donations, disclosing patients’ privacy, profit-making referrals, undermining the fairness of medical treatment, accepting “red packets” from the patient side, and accepting kickbacks from the enterprise, etc., which are in violation of the “nine guidelines” and the “clean practice”. Supervision of clean practice behaviours.
4. Whether to establish and improve the monitoring and early warning system and regulatory mechanism covering key positions, key personnel, key medical behaviours, important medicines and consumables, large-scale medical equipment, infrastructure construction, large-scale repair projects and other key nodes, and to properly deal with problems and make continuous improvements.
5. Whether to implement the integrity of medical research and related codes of conduct, and strengthen the supervision of research integrity.
06
From 1 February, encourage the development of these medical devices
On 29 December last year, the National Development and Reform Commission (NDRC) issued the Guidance Catalogue for Industrial Structure Adjustment (2024 edition). The new version of the catalogue will come into force on February 1, 2024, and the Guidance Catalogue for Industrial Structure Adjustment (2019 edition) will be repealed at the same time.
In the field of medicine, the innovative development of high-end medical devices is encouraged.
Specifically, it includes: new gene, protein and cell diagnostic equipment, new medical diagnostic equipment and reagents, high-performance medical imaging equipment, high-end radiotherapy equipment, life support equipment for acute and critical illnesses, artificial intelligence-assisted medical equipment, mobile and remote diagnostic and treatment equipment, high-end rehabilitation aids, high-end implantable and interventional products, surgical robots, and other high-end surgical equipment and consumables, biomedical materials, additive manufacturing technology development and application. technology development and application.
In addition, intelligent medical treatment, medical image auxiliary diagnostic system, medical robot, wearable devices, etc. are also included in the encouraged catalogue.
07
By the end of June, the construction of close-knit county medical communities will be comprehensively pushed forward
At the end of last year, the National Health Commission and other 10 departments jointly issued the Guiding Opinions on Comprehensively Promoting the Construction of Close-knit County Medical and Healthcare Communities.
It mentions that: by the end of June 2024, the construction of close-knit county medical communities will be comprehensively pushed forward on a provincial basis; by the end of 2025, significant progress will be made in the construction of county medical communities, and we will strive for the completion of close-knit county medical communities with reasonable layouts, unified management of human and financial resources, clear powers and responsibilities, efficient operation, division of labour, continuity of services, and sharing of information in more than 90% of the counties (municipalities) nationwide; and by 2027, the construction of close-knit county medical communities will be comprehensively promoted. By 2027, close-knit county medical communities will basically achieve full coverage.
The Circular points out that it is necessary to improve the grassroots telemedicine service network, realise remote consultation, diagnosis and training with higher-level hospitals, and promote mutual recognition of grassroots examination, higher-level diagnosis and results. Taking the province as a unit, the telemedicine service will cover more than 80% of township health hospitals and community health service centres in 2023, and basically achieve full coverage in 2025, and promote the extension of coverage to the village level.
Driven by the construction of county medical communities across the country, the market demand for grassroots device procurement is rapidly increasing, and the competition for the sinking market is escalating hotly.
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Post time: Feb-28-2024