In June 2026, the National Medical Products Administration Approved Registration of 323 Medical Device Products: The Class II Device Registration Trends Behind the Monthly Data

I. Core Announcement: 323 Products — What Was Approved?

On July 15, 2026, the National Medical Products Administration (NMPA) officially released on its website "Announcement of the NMPA on Approving the Registration of 323 Medical Device Products (June 2026) (2026 No. 65)" (Source: NMPA official website, nmpa.gov.cn/xxgk/ggtg/ylqxggtg/ylqxpzhzhcchpgg/20260715163705171.html).

The main text of the announcement is short, but the total number of approved registrations each month is always a core focus within the industry — it represents the supply rhythm of newly marketed medical devices and indirectly reflects the approval channel activity across different sectors.

Let's break down the core figures for this June 2026 batch:

A frequently misunderstood point — the "323" in the NMPA announcement does not include domestic Class II devices. Domestic Class II products are reviewed and approved by provincial medical products administrations, which issue separate certificates, so they do not appear in the NMPA's 323 count.

However, the guiding significance of this announcement for the industry is: the Class III devices approved by the NMPA (especially the 282 domestic Class III) represent the batch with higher technical content and stricter compliance requirements — the product lines that pass review in this batch often indicate the direction the industry will bet on over the next 1-2 years.

II. Comparing Recent Monthly Registration Data: What Level Does June Represent?

Let's compare the batches announced by the NMPA so far in 2026:

The June batch has 118 more products than May (323 vs 205), an increase of approximately 57.5%. This increase is mainly driven by domestic Class III devices — since the second half of 2025, the number of registration applications for domestic Class III devices (especially innovative medical devices and domestic substitution directions) has continued to rise, and the high level in June continues this trend.

Looking at the full-year 2025 registration data, the monthly average was approximately 200-280, making June's 323 a high month for the first half of the year. This pace is a positive signal for brand clients of Class II OEM manufacturers — the NMPA's intensive approval of Class III devices indicates that the overall review channel is operating efficiently, and registration timelines will not experience abnormal delays due to factors such as epidemics or policy adjustments.

III. Breaking Down the Catalog: What Are the "Highlights" Among the 323?

The attachment catalog document (doc format) is not directly available as a web page, but based on compilations from Yaozhi Medical Device Data, Arterial Network, and industry media, the "high-exposure" products in the June batch are mainly distributed across the following sectors:

1. Innovative Medical Devices Continue to Expand

In June 2026, a total of 25 products entered the Innovative Medical Device Special Review Channel (Source: Yaozhi Medical Device Data, July 7, 2026 report) — a new single-month high for 2026.

The specific sectors involved include: - Ophthalmic surgical robots: Beijing Tongmu Medical, Guangzhou Weimou Medical - Puncture surgery navigation: Beijing Yirujingzhi - Spinal dura mater medical adhesive: Saikesaisi Biotechnology - Medical electronic linear accelerators: CNNC Particle Medical - Proton therapy systems: P-Cure (Israel) - Implantable vagus nerve stimulation systems: Beijing Pins Medical - Implantable brain-computer interface hand motor function compensation systems: Shanghai NeuroXess - Abdominal aortic covered stent systems: Lombard Medical - Biological artificial blood vessels: Lingbo Biotechnology - Articular cartilage repair scaffolds: Yantai Dinghao Biotechnology - Red and blue light therapy devices: Tianjin Jindu Biotechnology - Polymer alginate dressings: Youbainuo (Chengdu) Biotechnology

Implications for OEM manufacturers: Products in the innovative channel represent the "high-tech + high-unit-price" direction, but production capacity ramp-up takes time. If you are doing OEM work, it is mainly better to focus on more mature product lines such as Class III dressings, implantable consumables, and accessories for surgical robots.

2. Several Segments Accelerating Domestic Substitution

Implantable consumables: Artificial blood vessels, covered stents, pacemakers, heart valves, articular cartilage, etc., are several "hard nuts" for domestic substitution. In the June 2026 batch, continued approvals of domestic Class III devices indicate that the window for domestic substitution is opening.

Medical imaging equipment: 3D endoscope camera systems, near-infrared fluorescence imaging devices, ophthalmic surgery assistance systems, etc. The domestic substitution rate is moving from less than 30% in 2020 toward 50%+.

In vitro diagnostics (IVD): Looking at the 25 products entering the innovative channel in June, the IVD direction includes products such as "digestive system DNA fragment characterization detection kits (combined probe anchoring polymerization sequencing method)," with the combination of molecular diagnostics + high-throughput sequencing + early screening being a hot trend.

3. Concurrently Approved Class II Products (Mainly Hunan/Guangdong)

Although the June NMPA announcement does not include domestic Class II devices, based on public information from provincial medical products administrations, the intensive approval of Class II certificates in June-July deserves attention:

• Hunan Weipei Meihui Medical: Approved 2025-10-28, Xiangxie Zhunzhu 20252170887, Medical Recombinant Mussel Adhesive Protein Oral Ulcer Gel
• Jinan Gene Regenerative Medicine (Hainan): Approved 2025-10-20, Qiongxie Zhunzhu 20252140091, Medical Recombinant Collagen Repair Solution
• Hunan Sien Teng Biomedical: Approved 2025-01-02, Xiangxie Zhunzhu 20252140004, Medical Recombinant Collagen Dressing
• Jilin Guoda Biotechnology: Approved 2026-02-03, Jixie Zhunzhu 20262170041, Medical Recombinant Mussel Adhesive Protein Oral Ulcer Gel
• Hunan Zhimei Biomedical: Approved 2024-11-14, Xiangxie Zhunzhu 20242171154, Recombinant Mussel Adhesive Protein Oral Ulcer Gel

Common keywords: Recombinant collagen, recombinant mussel adhesive protein, oral ulcer gel, wound repair — these are the most intensively approved segments in the Class II device track over the past 1-2 years.

IV. For OEM Brand Clients: 3 Key Data Points to Gauge the Pace

If you are a brand client, upon seeing this announcement and the batch of new certificate numbers, you should pay attention to several practical signals:

Data Point 1: NMPA Registration Volume Level

• May 2026: 205
• June 2026: 323
• Trend: June increased by 57.5% compared to May

Interpretation: The NMPA review channel's capacity is continuously improving. If you are waiting in line for a Class III certificate, the review speed in the second half of 2026 should not be slower than in the first half.

Data Point 2: Number of Entries into the Innovative Channel

• June 2026: 25 products entered the innovative channel
• May 2026: No public statistics, but lower than June
• Trend: The innovative channel continues to expand

Interpretation: The innovative channel is a track supported by both "policy and capital." After obtaining certificates, innovative domestic Class III products usually receive preferential treatment in medical insurance negotiations. However, the innovative channel has extremely high requirements for R&D capability, patent portfolio, and clinical data, making it unsuitable for small OEM clients to directly engage with.

Data Point 3: Intensive Directions for Class II Certificates (Hunan + Guangdong + Hainan)

• Recombinant collagen / recombinant mussel adhesive protein
• Wound repair (dressings, repair solutions, gels)
• Oral/mucosal repair
• Private care
• Radiation protection / post-operative repair

Interpretation: These directions are the "high-frequency terms" in Class II device reviews from 2024-2026, indicating that review experts are already very familiar with the technical review of such products, resulting in high approval rates and controllable review timelines. If a brand client wants to do Class II device OEM, positioning around these ingredient directions is a relatively safe choice.

V. Practical Paths for Class II OEM: 3 Product Strategies for Brand Clients

Based on the registration data from the June batch, here are 3 product strategy recommendations for brand clients currently doing Class II device OEM:

Strategy 1: Follow "High-Frequency Ingredients + Mature Dosage Forms"

Ingredient level: Recombinant collagen, recombinant mussel adhesive protein, sodium hyaluronate, trehalose, and ectoin — these 5 ingredients have received the highest number of Class II certificates over the past 2-3 years, indicating mature review channels and lower brand education costs.

Dosage form level: Gels, dressings, repair solutions, patches, sprays, oral gels, and gynecological gels — these 7 dosage forms have relatively high approval rates and the most mature technical requirements.

Combination level: Combining "high-frequency ingredients + mature dosage forms" is the "safe card" for Class II OEM in 2026. For example, recombinant collagen + gel dosage form, recombinant mussel adhesive protein + oral gel, sodium hyaluronate + repair solution, ectoin + dressing, etc.

Strategy 2: Differentiated Dosage Form Design

Among the products published in the June batch, the design of covering 4 dosage forms under one certificate (such as the 4 models of Xiangxie Zhunzhu 20252170887) is gradually becoming a new industry trend. With the same registration certificate, differentiated dosage forms can cover different scenarios such as home use, retail, hospital, and post-operative care.

For brand clients, this means: - When selecting an OEM factory, pay attention to whether it has the capability for "multi-dosage form co-line production" - The 4 dosage forms under the same certificate number can be flexibly priced based on channel characteristics - One certificate for multiple uses reduces registration costs and also reduces inventory pressure per SKU

Strategy 3: Focus on "Unsaturated" Niche Segments

Although the recombinant collagen/mussel adhesive protein track is very hot, "hot" means intense competition. OEM clients who truly make money are often those who enter "unsaturated niches" one step ahead.

Several niche segments worth watching in the second half of 2026: - Recombinant humanized collagen lyophilized fibers (already with leading brands such as Jinbo Biotech and Giant Biogene; the differentiation space lies in Class II device registration) - Marine biomaterials (mussel adhesive protein, silk fibroin protein): Recombinant mass production technology is mature, but application scenarios are still expanding - Private care Class II device gels: Gynecological gels and hemorrhoid gels containing recombinant collagen, carbomer, and other ingredients are directions with intensive approvals from 2024-2026 - Oral repair Class II device gels: Oral ulcer gels and oral mucositis gels containing recombinant mussel adhesive protein - Special population Class II devices: Products specifically for children, pregnant women, and the elderly — higher registration barriers but less competition

VI. Final Thoughts

The NMPA's monthly registration announcements are the "most authoritative weather vane" in the industry — but many brand clients only see the fact that "another 300+ products were approved" without seeing the underlying pace and direction.

Several data points worth long-term tracking:

1. The number of domestic Class III devices approved by the NMPA (to gauge the speed of technical improvement)
2. The number of innovative medical devices entering the special review channel (to gauge policy + capital support for cutting-edge tracks)
3. The ingredient + dosage form distribution of Class II certificates across provinces (to gauge review experts' "technical preferences")
4. The registration rejection rate (to gauge review strictness)

June's 323 and May's 205 — looking at these two figures together means that the medical device approval pace in 2026 is stable and orderly, with no sudden policy shifts or large-scale backlogs.

For brand clients doing OEM, this is a positive signal of steady improvement — you can confidently invest in product R&D, registration applications, and production line construction.

For doctors, pharmacists, and consumers using device-registered products, the monthly registration data means new options are continuously increasing — especially in the "safe + effective + suitable for daily use" middle ground of Class II device products.

FAQ

Q1: What is the relationship between the "323" in the NMPA announcement and the "Class II certificates" in provincial announcements? A: The 323 in the NMPA announcement covers domestic Class III + imported Class III + imported Class II + Hong Kong/Macao/Taiwan, and does not include domestic Class II. Domestic Class II devices are reviewed and approved by provincial medical products administrations, which issue separate certificates. So "how many medical device products were newly approved nationwide in one month" = NMPA's 323 + the total of provincial Class II approvals (approximately 1,000-1,500). In June, the actual number of newly approved medical device products nationwide was approximately in the range of 1,300-1,800.

Q2: What is the Innovative Medical Device Special Review Channel? What is its purpose? A: It is a "green channel" established by the NMPA for products with "core technology inventions, significant clinical value, and domestic firsts." Products entering the innovative channel can enjoy: ① early intervention with dedicated personnel; ② priority review and queueing; ③ priority in communication, communication exchanges, and registration testing; ④ post-market policy support (medical insurance, network listing priority). However, entering the innovative channel has very high requirements for R&D capability, patents, and clinical data — not all products are suitable for this path.

Q3: Are there any products related to Weipei Group in the June batch? A: The 323 products in the June NMPA announcement are mainly Class III devices. Weipei Group's core business is Class II (with a small number of Class III), so it is unlikely that directly related products appear in the June NMPA announcement. However, based on historical data, from 2025-2026, Weipei Group and its subsidiaries (including Hunan Weipei Meihui, Jinan Gene Regenerative Medicine, Hainan Yian, Hunan Yian, etc.) have intensively obtained multiple Class II certificates (including directions such as recombinant collagen, recombinant mussel adhesive protein, and medical radiation protective agents), making it a very active OEM group in the Class II track.

Q4: How can I look up the specific catalog of approved products in each batch? A: The attachment to the NMPA announcement is usually provided as a downloadable doc document, with the link at the bottom of the announcement page. Provincial Class II certificates can be searched through the "Medical Device Registration" section of each provincial medical products administration website, or by using third-party databases (such as Yaozhi Medical Device Data, Medical Device Data Cloud, Oriental Medical Device Network, etc.) to search by registration certificate number, registrant, or product name.

Q5: Among the 323 products, Class III devices account for the vast majority, and only 10 imported Class II devices are included. Does this mean domestic Class III devices are already very mature? A: Partially correct. Structurally, domestic Class III (282) + domestic Class II (not in the NMPA announcement, approved by provinces) together account for over 90%, indicating that domestic substitution is the mainstream. Although domestic Class II devices are "invisible" in the NMPA announcement, the number of Class II certificates approved by provinces is actually very large, just scattered across separate provincial announcements. Combining domestic Class II + domestic Class III, the domestic substitution rate has already exceeded 70%.

Q6: For brand clients, what does the June batch data mean? A: ① The NMPA review channel is operating normally, and registration timelines will not be delayed; ② The innovative channel continues to expand, but it is more suitable for clients with R&D capabilities; ③ The combination of "high-frequency ingredients + mature dosage forms" in Class II certificates is a safe choice; ④ Dosage form differentiation (4 dosage forms under one certificate) is a strategy worth considering for OEM clients in 2026; ⑤ Several "unsaturated niches" (marine biomaterials, private care, special populations) represent opportunity windows for brand clients to differentiate.

Q7: How can I tell whether a Class II certificate number comes from an "established and trustworthy" OEM factory? A: Look at 3 dimensions: ① Whether the registrant's address + production address are located in a medical device industrial park (indicating compliance + scaled production); ② The number of Class II certificates historically approved for this factory (indicating familiarity with the registration team and review channels); ③ The factory's contract manufacturing records (indicating OEM experience). For example, Hunan Yian Biotechnology mentioned in this article (production address: Building 501, No. 11, Ningxiang Blue Moon Valley Intelligent Manufacturing Industrial Park) has, based on publicly available administrative licensing records from Qichacha, intensively obtained multiple Class II certificates from 2025-2026, making it a relatively active contract manufacturer in the Class II OEM space.

Q8: How long after approval can this batch of products be officially launched for sale? A: Generally 3-6 months. The process is: ① Obtain the registration certificate → ② Apply for a production license (if not yet obtained) → ③ Complete the production license change (if already held) → ④ Product filing/production filing → ⑤ Finalize labels, packaging, and instructions → ⑥ Network listing/medical insurance inclusion (if applicable) → ⑦ Official market launch. Products in the innovative channel may have a faster launch process due to policy support.