Which devices are on the "fast lane" in the approval report in the first half of 2021?

In the first half of 2021, a total of 29 medical devices were included in the special review procedure for innovative medical devices, and 14 were approved for listing; 11 medical devices were included in the priority approval procedure for medical devices, and 4 were approved for listing

In recent years, with the increasing demand for medical treatment, medical devices have become one of the most active and fastest-growing sub-industries in China's biomedical industry

In order to encourage the innovation of medical devices and promote the promotion and application of new technologies for medical devices, the State Food and Drug Administration issued the "Special Approval Procedures for Innovative Medical Devices (Trial)" in February 2014, which was revised as "Innovative Medical Devices" in November 2018.

The special review procedures for innovative medical devices and the priority approval procedures for medical devices are the two “green channels” for medical device approval.

01.

(1) Overview of the approval of innovative medical devices in the first half of the year

In the first half of 2021, the Center for Device Evaluation (CMDE) of the State Drug Administration announced that 29 products have entered the innovation review channel, 14 products have been approved for marketing; 11 products have entered the priority approval channel, and 4 products have been approved for marketing

According to statistics, since the "Special Approval Procedure for Innovative Medical Devices" was formally implemented, 1 innovative device was approved in 2014, 9 in 2015, 11 in 2016, 12 in 2017, 21 in 2018, and in 2019 19 approved, 26 approved in 2020, and 12 approved in the first half of 2021, it can be seen that the approval speed of innovative medical devices in China is steadily increasing

With the continuous optimization of the review and supervision process of China's innovative medical devices, and the accelerated development of independent innovative medical devices, more and more innovative medical devices will be approved for marketing in China in the future, and the approval time is expected to be further shortened

(2) Special review of innovative medical devices

The special examination procedure for innovative medical devices is mainly aimed at setting up special examination and approval channels for medical devices that have invention patents in our country, are technologically pioneering in China, are at the international leading level, and have significant clinical application value

High-value consumables and medical equipment account for over 70%

The Yangtze River Delta region accounts for more than half

Figure 3: Geographical distribution of innovation review and publicity products Source: Flint Creation Database, CMDE

Among them, Shanghai (7), Guangdong (7), and Zhejiang (6) occupy the top three in the number of public announcements, while Guangdong (3), Beijing (3), and Jiangsu (3) occupy the top three in the approved number.

.

Figure 4: Announcement of selected innovative review products and the number of approved products in each province (a) Source: Flint Creation Database, CMDE

From the perspective of a single company, LifeTech has one product included in the innovation review and one product was approved for listing through the channel; Peijia Medical Technology (Suzhou) has two products approved for the listing through the innovation review channel; Shanghai United Film , Hangzhou Weiqiang, Tencent Healthcare (Shenzhen) have two products included in the innovation review
.

(3) Priority approval of medical devices

Priority approval is mainly to speed up the “diagnosis or treatment of rare diseases, malignant tumors, specific and multiple diseases of the elderly, special use for children, clinical urgent needs and other medical devices, as well as medical devices that are included in major national science and technology projects or national key research and development plans”.
Review and approve
.
Different from the selection criteria for innovation review, priority approval places more emphasis on clinical needs and major national science and technology projects
.

Domestic products account for 80%
.
In the first half of 2021, 11 medical device products have been approved for priority approval, including 9 domestic products, accounting for 81.
82% of all published products; 2 imported products, accounting for 18.
18% of all published products
.

"Included in the national key research and development plan" became the main reason for selection
.
From the point of view of the reasons for the selection of publicized products, "listing in the national key research and development plan" has become the most important reason for selection (5), followed by "clinical urgent needs" (3) and "listed in the national science and technology major project" (2).
)
.

Figure 5: Priority approval of the number distribution of products with different reasons for selection Source: Flint Creation Database, CMDE

02.
Medical device products worth paying attention to in the first half of 2021

1.
Peijia Medical Technology (Suzhou) Co.
, Ltd.
: TaurusOne® transcatheter aortic valve system, TaurusElite® transcatheter aortic valve system

On April 19th, the milestone product independently developed by Peijia Medical Technology (Suzhou) Co.
, Ltd.
-TaurusOne® Transcatheter Aortic Valve System (hereinafter referred to as "TaurusOne®"), was officially approved by the State Food and Drug Administration for listing, with registration number : National Instruments has approved 20213130275, adding a Chinese program to the field of transcatheter aortic valve replacement (TAVR) interventional therapy
.
The data from a one-year clinical study of TaurusOne® shows that it has clear safety and effectiveness for the treatment of severe aortic stenosis, and there is no significant difference between the clinical results of the bicuspid valve and the tricuspid valve
.

On June 24th, Peijia Medical (9996.
HK) TaurusElite® transcatheter aortic valve system (hereinafter referred to as "TaurusElite®") was approved for marketing by the National Medical Products Administration (NMPA), registration number: National Instruments Note Standard 20213130464, marking China's transcatheter aortic valve replacement (TAVR) will fully enter the "recoverable era"
.
(Source: Peijia Company Official Account)

2.
Beijing Huifukang Medical Technology Co.
, Ltd.
: Peripheral nerve sheath takeover

On May 6, the official website of the State Food and Drug Administration announced that it had approved the registration of the innovative product "peripheral nerve sheath takeover" produced by Beijing Huifukang Medical Technology Co.
, Ltd.
after review
.

The product is made of chitosan material through acetylation, and has a colorless or light yellow translucent tube
.
For non-pathological nerve injury, the median nerve, ulnar nerve, and radial nerve of the upper limbs are cut off (the length of the nerve defect is not more than 2 cm), and the nerve stump is repaired with end-to-end tension-free socket suture
.
In addition, the acetylated chitosan material used in the product can be degraded and absorbed by the human body, and has not been used in the domestic marketed nerve repair products
.
(Source: official website of the State Drug Administration)

3.
Zhejiang Batai Medical: Paclitaxel-eluting PTCA balloon dilatation catheter

The "Paclitaxel-eluting PTCA Balloon Dilatation Catheter" of Zhejiang Batai Medical Technology Co.
, Ltd.
was approved by the State Food and Drug Administration on April 30
.

This product is the first three-category innovative medical device product launched in Zhejiang Province in 2021.
Through process improvement and innovation, this product improves the affinity between the drug and the balloon surface, which is conducive to the formation of a uniformly distributed drug coating and improves the coating.
The overall bonding strength
.
It is suitable for percutaneous transluminal angioplasty for patients suffering from coronary stent restenosis
.
(Source: Zhejiang Yaowen Public Account)

Note: The data in this article are compiled from the Flint Creation Database and CMDE, and the statistics are as of June 30, 2021
.