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Overview of new policies and development expectations for China medical device industry in 2025

Looking back at 2024, the medical device industry is changing with each passing day.

Volume-based procurement is still being intensively promoted, and many so-called “collective procurement restricted areas” have been breached one after another, and the implementation of the selected results has also ushered in comprehensive supervision; various new medical policies have been introduced one after another, and measures such as consumables traceability codes, direct settlement between medical insurance and enterprises, and mutual recognition of inspection results have accurately sniped the old malpractices in the field of medical devices, and official industry regulations are also being updated simultaneously.

Medical anti-corruption is still powerful, and the bidding process closely related to medical devices has been named many times by the Central Commission for Discipline Inspection. Grassroots corruption, fraud and insurance fraud have also been focused on; the large-scale equipment update launched in early 2024 is about to enter the volume period, and the temporarily delayed procurement demand will be quickly marketed this year.

2025 has arrived, and a new industry cycle has begun.

1. Intensive implementation + strict management and execution
2. The consumables traceability code is rolled out nationwide, and the price monitoring mechanism is upgraded
3. Direct settlement and prepayment are accelerated, and the collection environment of the pharmaceutical and medical device industry is improved


4. In August 2024, the General Department of the State Drug Administration publicly solicited opinions on the “Medical Device Management Law of the People’s Republic of China (Draft for Comments)”. The “Draft Opinion” has 11 chapters and 190 articles, covering all aspects of medical device research and development, production, operation, and use, as well as standards, classification, warnings, recalls, etc. (See: “Medical Device Management Law (Draft for Comments) Released | Attached Full Text + Highlights”). At present, the “Draft Opinion” has completed feedback and is expected to be officially implemented in 2025.
In addition, the latest revised “Medical Device Supervision and Management Regulations” will be implemented on January 20, 2025
5. The 2025 National Health and Health Work Conference was held in Beijing. It was mentioned that 2025 is the final year of the “14th Five-Year Plan”. We must strengthen the construction of clean government and vigorously deepen the rectification of unhealthy practices and corruption around the people.
6. With the vast overseas market space and the increasing domestic competition pressure, going overseas has become the best solution for medical device companies to expand their business growth, and it is also the only way for leading brands to go international and global.

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Post time: Jan-06-2025