On November 25, Aipeng Medical announced that the company's wholly-owned subsidiary, Aipeng Medical Technology (Hunan) Co.
, Ltd.
, recently obtained the "Medical Device Registration Certificate"
issued by the Hunan Provincial Drug Administration.
The product name is fixed holding anti-snoring device, the scope of application can extend the patient's jaw forward, used for the adjuvant treatment
of sleep snoring or obstructive apnea.
For this approval, Aipeng Medical said that the approval of the registration certificate for fixed maintenance anti-snoring device has enriched the company's product categories in the sleep field, which can better open the market, which is conducive to further improving the company's market expansion ability and will have a positive impact
on the company's future operation.
Coincidentally, before that, Antu Biotech also issued an announcement that the company recently received a medical device registration certificate issued by the State Medical Products Administration, product name: Mycoplasma pneumoniae/Chlamydidium pneumoniae/adenovirus nucleic acid detection kit (PCR-fluorescent probe method).
It is understood that the acquisition of the above-mentioned medical device registration certificate has also further enriched the menu of Antu Biologics, continuously met market demand, and is an effective supplement
to the company's existing molecular diagnostic products.
For many enterprises to frequently obtain registration certificates for medical devices, analysts pointed out that it is mainly due to the current promotion of multiple benefits such as encouraging innovative medical devices, easing the marginal of centralized procurement policies, and supporting equipment renewal with financial discount loans, the development of the medical device board industry has begun to accelerate
.
At present, with the enthusiasm of enterprises for R&D, the increasing investment in R&D, and the acceleration of review and approval, medical device innovation is also accelerating
.
Recently, a number of domestic innovative medical devices have also been approved for marketing
.
For example, on November 14, the State Medical Products Administration approved the registration application for artificial bone repair materials submitted by Wuhan Asia Biomaterials Co.
, Ltd.
, which is the first medical device
with artificial biological activity multi-level structure artificial bone repair materials approved for marketing in China 。 This multi-stage structural artificial bone repair material medical device with artificial biological activity jointly developed by the biological materials and medical device regulatory scientific transformation team of Huazhong University of Science and Technology and Wuhan Asia Biomaterials Co.
, Ltd.
, from key raw materials to technology produced nationwide, has been proved by multi-center clinical trials that the bone graft fusion rate is as high as 100%, showing excellent safety and reliability, and obvious price advantages
.
After the product registration application was approved, Wuhan Asia Biomaterials Co.
, Ltd.
immediately submitted the change of production license to the Hubei Provincial Food and Drug Administration, and obtained the production license
at the same time.
It is understood that the product will be put into large-scale production at the end of this month and applied to clinical practice, which is expected to play a leading role in the high-quality development of the high-end medical device industry in Hubei Province, thereby attracting more high-end medical device enterprises to settle in Hubei and innovate and develop
.
On November 10, the National Medical Products Administration released a dynamic display that the innovative medical device "left atrial appendage occluder system" produced by Hangzhou Denuo Electrophysiology Medical Technology Co.
, Ltd.
was approved
.
According to reports, the product is suitable for patients
with non-valvular atrial fibrillation who are at risk of stroke and long-term oral anticoagulation therapy is contraindicated.
It is worth mentioning that the design of the sealing disc and anchor disc of the product adopts an innovative patented design, which makes full use of the adaptability of the nitinol wire braided structure, which can meet the clinical sealing needs
of different forms of left atrial appendage to a certain extent.
Industry analysts believe that in view of the current policy determination of the pharmaceutical industry to collect and control fees, "innovation" will be the main theme
of the development of the domestic equipment industry for a long time.
It is understood that as early as 2018, the State Food and Drug Administration revised and issued the Special Review Procedure for Innovative Medical Devices; The Regulations on the Supervision and Administration of Medical Devices, which came into effect on June 1, 2021, propose to give priority to the review and approval
of innovative medical devices.
In addition, in the "Medical Equipment Industry Development Plan (2021-2025)" issued by the Ministry of Industry and Information Technology, it is also proposed that by 2025, 6 to 8 domestic device companies will be promoted to the top
50 in the global medical device industry.
In general, the domestic medical device innovation market has a broad space for growth, and at present, in innovative medical devices, industry analysts believe that subdivisions such as vascular intervention, orthopedic instruments, surgical robots and other subdivisions may contain more investment opportunities, and related companies can increase attention
.
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