I. Regulatory Boundaries: Why "Muscle-Relaxing Anti-Wrinkle" Claims Are Difficult to Sustain Under Cosmetic Registration
1.1 The Underlying Logic Behind the Cancellation of Conotoxin Peptide
The new cosmetic ingredient conotoxin peptide (National Cosmetic Raw Material Registration No. 20230010), filed by Vicky Technology, will be officially cancelled on August 31, 2026. The official reason cited is that its "actual function exceeds the scope defined for cosmetics."
This statement must be understood in the context of the Regulations on the Supervision and Administration of Cosmetics. According to Article 2 of the Regulations, cosmetics are defined as "daily-use chemical industrial products applied to the surface of the human body, such as the skin, hair, nails, and lips, by rubbing, spraying, or similar methods, for the purposes of cleansing, protection, beautification, and modification."
The key point is: the effects of cosmetics must be superficial and physical, and must not possess medical or pharmacological effects.
The core efficacy claim of conotoxin peptide is "relaxing muscles and smoothing expression lines by blocking sodium ion channels." This mechanism directly acts on neuromuscular signal transmission and exhibits clear pharmacological activity. Although the actual concentration reaching the muscle layer may be very low when applied topically due to the skin barrier, from the perspective of the ingredient's inherent functional properties, it is closer to a drug than a cosmetic ingredient.
1.2 Signals of Tightening Regulation
The cancellation of conotoxin peptide is not an isolated case. In recent years, the National Medical Products Administration (NMPA) has shown a clear trend toward stricter control over the functional boundaries of cosmetic ingredients:
- June 2023: The Guangzhou Municipal Market Supervision Administration explicitly prohibited the marketing of arginine/lysine peptides as "conotoxin peptide," with 1,480 products required to rectify their claims
- 2025 Special Rectification Campaign: 1,426 batches of general cosmetics claiming to contain conotoxin peptide were inspected, with a non-compliance rate of 77.3%
- August 2026: The registration of conotoxin peptide as a new cosmetic ingredient will be officially cancelled
This series of actions sends a clear signal: any ingredient with explicit pharmacological activity may face more rigorous scrutiny. The functional boundaries of cosmetic ingredients are being redefined, with "strict entry and strict oversight" replacing "lenient entry and strict oversight."
1.3 Far-Reaching Impact on the Industry
The cancellation of conotoxin peptide affects the entire anti-aging industry on three levels:
Brand Level: Products positioned around the "topical Botox" selling point need to urgently adjust their formulations and marketing messaging. Hanhoo's conotoxin peptide product line achieved a GMV of RMB 1.84 billion in 2025, and Marubi's Little Red Pen Eye Cream series has initiated the cancellation of its registration.
OEM/ODM Level: A large number of contract-manufactured products featuring conotoxin peptide as a key selling point need to urgently reformulate and re-register. OEM companies face multiple pressures, including formulation adjustment costs, registration lead times, and client communication.
Ingredient Level: Muscle-relaxing and neuro-modulating anti-wrinkle ingredients will all face stricter review. Arginine/lysine peptides (the already-listed ingredient long colloquially referred to as "conotoxin peptide") have also been reported to cease shipments by the end of 2026.
II. Compliance Advantages of Medical Device Registration for Anti-Aging
As the space for efficacy claims under cosmetic registration is compressed, the advantages of the medical device track become increasingly prominent.
2.1 Greater Room for Efficacy Claims
Limitations of Cosmetic Registration:
- Only claims of "cleansing, protection, beautification, and modification" are permitted
- Must not claim medical or pharmacological effects
- Must not use medical terminology such as "treatment," "repair," or "wrinkle improvement"
- The functional scope of raw materials is strictly limited to "surface effects and physical effects"
Advantages of medical device registration (Class II):
- Can claim "auxiliary wrinkle improvement," "skin repair," "wound healing," etc.
- Can use professional terms such as "medical device" and "medical grade"
- Broader selection of raw materials, including ingredients with clear biological activity
- Efficacy claims are supported by registration certificates, ensuring strong regulatory compliance
2.2 Higher Consumer Trust
The registration and approval process for medical devices is rigorous, involving multiple stages such as clinical validation, technical review, and quality system audits. Consumers naturally place greater trust in products bearing a "medical device registration certificate number."
Particularly in the anti-aging sector, consumers are becoming more rational, no longer satisfied with products featuring "concept-based additions" or "trace-level ingredients," but instead seeking products backed by real efficacy data. Medical device-registered products precisely meet this demand.
2.3 Higher Competitive Barriers
Applying for a Class II medical device registration certificate requires:
- A registration cycle of 12–18 months
- Complete clinical validation data
- A Class 100,000 cleanroom facility
- ISO 13485 quality management system certification
- Ongoing compliance with good manufacturing practices
These barriers keep a large number of small and medium-sized enterprises out of the market, making them a valuable competitive moat for companies that already hold the necessary qualifications.
2.4 Greater Policy Support
In recent years, national policy support for the medical device industry has continued to strengthen:
- Green channel for review and approval of innovative medical devices
- Pilot program for the medical device registrant system
- Policy incentives for medical device industrial parks
In contrast, the cosmetics industry faces tighter regulation and rising compliance costs.
III. Analysis of Core Anti-Aging Ingredients for Medical Device Registration
With conotoxin peptide exiting the market, which ingredients can take on anti-aging needs within the medical device framework? Below is an in-depth analysis of the four core ingredients.
3.1 Recombinant Collagen: The "All-Rounder" in the Anti-Aging Arena
Basic Information:
- Collagen obtained through expression via genetic engineering technology
- Highly consistent with the amino acid sequence of human collagen
- Excellent biocompatibility with no immune rejection response
Mechanism of Action:
- Supplements structural proteins in the skin to improve skin laxity
- Promotes fibroblast proliferation and stimulates endogenous collagen synthesis
- Provides hydration and moisture retention, improving skin barrier function
Approved Products: Multiple Class II medical device registrations featuring recombinant collagen as the core ingredient have been approved for use in:
- Wound repair following facial laser, intense pulsed light (IPL), and radiofrequency procedures
- Repair of superficial skin wounds
- Auxiliary improvement of wrinkles
Core Advantages:
- Safe and gentle with no sensitization risk
- Dual benefits of repair and anti-aging
- Policy-backed with multiple established industry standards
- Claims such as "auxiliary wrinkle improvement" and "skin repair" are permitted
Guangdong Weital's Advantages: We have completed the registration and filing of 78 Class II medical device products, with our recombinant collagen series covering multiple dosage forms including gels, dressings, and sprays to meet diverse anti-aging application scenarios.
3.2 Mussel Adhesive Protein: A Rising Star in Wound Repair and Anti-Aging
Basic Information:
- Adhesive protein extracted from mussels (blue mussels)
- Rich in DOPA (3,4-dihydroxyphenylalanine) groups with strong adhesive properties
- High bioactivity with significant repair efficacy
Mechanism of Action:
- Promotes wound healing and accelerates tissue repair
- Provides antioxidant effects by scavenging free radicals
- Hydrates and locks in moisture, improving the skin barrier
- Auxiliary improvement of wrinkle appearance
Approved Products: Mussel adhesive protein has been approved as a core ingredient in multiple Class II medical device registrations for use in:
- Skin wound repair
- Post-procedure care
- Anti-aging care
Core Advantages:
- Significant repair efficacy, particularly suited for post-procedure care scenarios
- Outstanding antioxidant properties
- Naturally derived with high safety profile
3.3 Hyaluronic Acid: A Classic Ingredient for Hydration and Filling
Basic Information:
- Naturally present in human skin, joints, and other tissues
- Extremely strong water-retention capacity (1g of hyaluronic acid can lock in 1000g of water)
- Obtained through microbial fermentation
Mechanism of action:
- Deep moisturization, improving dry skin
- Filling wrinkles, improving skin smoothness
- Promoting tissue repair
Approved products: Hyaluronic acid is one of the most widely used ingredients in Class II medical devices, with a large number of approved products for:
- Facial moisturizing care
- Wrinkle filling
- Wound repair
Core advantages:
- Mature technology with a stable supply chain
- High safety profile with extensive clinical application
- Controllable costs
3.4 Silicones: Scar Repair + Skin Smoothing
Basic information:
- Organosilicon polymers
- Good biocompatibility
- Form a breathable protective film
Mechanism of action:
- Maintain a moist wound environment
- Soften and flatten scar tissue
- Improve skin texture
Approved products: Silicone-based products are primarily used for:
- Scar repair
- Post-surgical skin smoothing
- Skin protection
Core advantages:
- Proven efficacy in scar repair
- High safety profile
- Relatively low cost
IV. From Cosmetics Registration to Medical Device Registration: The Transformation Path for OEM/ODM Enterprises
4.1 The Necessity of Transformation
The cancellation of the conotoxin peptide registration has made more companies realize that under the backdrop of tightening regulations, the space for efficacy claims under cosmetics registration is being compressed. For anti-aging products that require stronger efficacy claims, transitioning to the medical device registration track is an inevitable choice.
The necessity of transformation is reflected in: **Market Demand Drivers**: - Consumers have increasingly high efficacy requirements for anti-aging products - Concepts like "topical Botox" have already established mindshare among end consumers - Cosmetics registration (妆字号) cannot claim efficacy such as "anti-wrinkle" or "repair," making it difficult to meet market demand **Competitive Pressure Drivers**: - The cosmetics registration track is highly competitive with severe homogenization - The medical device registration track (械字号) has high entry barriers and strong competitive moats - Companies that secure medical device registration early will gain first-mover advantages **Compliance Risk Drivers**: - The functional boundaries of raw materials under cosmetics registration are being redefined - Claiming efficacy such as "anti-wrinkle" or "repair" may pose compliance risks - Medical device registration is backed by registration certificates, offering strong compliance assurance **4.2 Core Conditions for Transformation** Transitioning from cosmetics registration to medical device registration requires the following core conditions: **Hardware Requirements**: - Class 100,000 cleanroom (ISO Class 7) - Purified water system - Clean air conditioning system - Sterilization equipment **Software Requirements**: - ISO 13485 Quality Management System certification - Professional regulatory submission team - Complete clinical validation data - Ongoing Good Manufacturing Practice (GMP) compliance **Financial Requirements**: - Class II medical device registration application fee: RMB 500,000–1,000,000 per certificate - Registration timeline: 12–18 months - Cleanroom construction/renovation cost: RMB 2–5 million **4.3 Specific Transformation Pathways** **Pathway 1: Independent Registration Application** Suitable for companies with sufficient financial resources and long-term plans to establish a presence in the medical device registration track. Steps: 1. Product development and formulation design 2. Establishment of quality system (ISO 13485) 3. Cleanroom construction/renovation 4. Product registration testingPath 2: OEM/ODM Contract Manufacturing Partnership
Suitable for companies looking to quickly enter the medical device track without bearing the costs and risks of applying for a registration certificate.
Advantages:
- No need to apply for a registration certificate independently
- Rapid time-to-market
- Reduced financial risk
Guangdong Weitai already holds 78 Class II medical device registration certificates, covering core ingredients such as recombinant collagen, mussel adhesive protein, and hyaluronic acid, offering one-stop OEM/ODM contract manufacturing services to brand owners.
Path 3: Acquiring a Certified Company
Suitable for companies with strong financial resources seeking to quickly obtain qualifications and production capacity.
Advantages:
- Rapid acquisition of registration certificates and production qualifications
- Access to existing team and customer resources
Risks:
- High acquisition costs
- Integration risks
4.4 Typical Case Studies of Transformation
Case 1: A Cosmetics Brand Transitioning to Medical Device Track
Background: A cosmetics brand with "smear-on Botox" as its core selling point faced formulation adjustment pressure after conopeptide was deregistered.
Transformation strategy:
- Partnered with Guangdong Weitai, selecting recombinant collagen gel as the core product
- Leveraged Weitai's existing Class II medical device registration certificates
- Redesigned brand image and marketing strategy, shifting from "smear-on Botox" to "medical device-grade anti-aging"
Results:
- Product launched within 3 months
- Product pricing increased by 50%
- Repeat purchase rate increased by 30%
Case 2: An OEM Company Expanding into the Medical Device Track
Background: A cosmetics OEM company primarily focused on cosmetics-grade contract manufacturing, facing increased customer attrition risk after conopeptide was deregistered.
Transformation strategy:
- Invested in building a Class 100,000 cleanroom workshop
- Applied for ISO 13485 certification
- Collaborating with Guangdong Weitai to share registration certificate resources
- Gradually increasing the share of medical-device-grade (械字号) OEM business
Results:
- Completed cleanroom construction and system certification within 1 year
- Medical-device-grade business share increased from 0% to 30%
- Optimized client structure and enhanced resilience against risks
V. Guangdong Weitai's Medical-Device-Grade Anti-Aging OEM Capabilities
5.1 Qualification Advantages
Guangdong Weitai Biotechnology Co., Ltd. is a National High-Tech Enterprise (certified in 2024) and an Anhui Province "Specialized, Refined, Distinctive, and Innovative" enterprise. It holds triple production qualifications for cosmetics-grade (妆字号), medical-device-grade (械字号), and disinfection-grade (消字号) products, making it one of the few companies in the industry with full-category OEM capabilities.
Core Qualifications:
- 78 Class II medical device registration certificates
- ISO 13485 Medical Device Quality Management System certification
- ISO 22716 Cosmetic GMP certification
- U.S. GMPC certification
- 72 patents
- Contributed to the development of 3 industry standards
5.2 Product Advantages
The 78 Class II medical device products we have completed cover the following core categories:
Recombinant Collagen Series:
- Recombinant collagen repair dressings (gel/liquid/sheet mask)
- Recombinant collagen wound repair spray
- Recombinant collagen repair patches
- Suitable for post-operative wound repair after laser, IPL, and radiofrequency procedures, as well as auxiliary improvement of wrinkles
Mussel Adhesive Protein Series:
- Mussel adhesive protein repair dressings
- Mussel adhesive protein wound repair spray
- Suitable for skin wound repair and post-operative care
Hyaluronic Acid Series:
- Hyaluronic acid repair dressings
- Hyaluronic acid wound repair spray
- Suitable for facial hydration care and wound repair
Other Series:
- Silicone gel dressings (scar repair)
- Medical cold compress patches (cold therapy)
- Liquid dressings (wound protection)
5.3 Production Capacity Advantages
Guangdong Weptide operates four major production bases:
| Base | Location | Functional Focus |
|---|---|---|
| Operations Center | 8F, Baiyun Meiwan Testing Building, No. 408 Guangyun Road, Baiyun District, Guangzhou | R&D, Sales, Operations |
| Foshan Factory | No. 18 Taoyuan East Road, Songgang Songxia Industrial Park, Shishan Town, Nanhai District | Cosmetics-grade + Medical device-grade production |
| Guangzhou Factory | No. 77 Dalang North Road, Baiyunhu Street, Baiyun District | Cosmetics-grade production |
| Hunan Yian | Room 501, Building 11, Lanyue Valley Industrial Park, Xieyuan North Road, Ningxiang Economic Development Zone, Ningxiang City | Medical device-grade production (Class 100,000 cleanroom) |
| Zhaoqing Factory | No. 2 Wende Fifth Street, Zhaoqing High-tech Zone | Cosmetics-grade + Disinfectant-grade production |
Among these, the Hunan Yian base is equipped with a Class 100,000 cleanroom dedicated to the production of Class II medical devices, with an annual capacity of up to 50 million units.
5.4 Service Advantages
One-stop OEM/ODM services:
- Custom formulation: Tailored formulations developed based on brand positioning and target demographics
- Registration certificate support: Authorized use of 78 existing Class II medical device registration certificates
- Packaging design: Packaging design recommendations in compliance with medical device labeling regulations
- Filing services: Assistance with product filing and registration applications
- Production and delivery: Strict adherence to ISO 13485 system requirements to ensure consistent quality
Rapid response capability:
- Proven formulations available for immediate selection, with samples delivered within 7 days
- Custom formulations: samples delivered in 15–30 days
- Mass production lead time: 15–25 days
VI. Conclusion: The Next Big Opportunity in the Anti-Aging Market Lies in Medical Device-Grade Products
The deregistration of conotoxin peptide is, on the surface, a compliance issue for a single ingredient, but in essence, it reflects a redefinition of the functional boundaries of cosmetic ingredients by regulators. When "muscle-relaxing anti-wrinkle" claims can no longer hold within the cosmetic registration framework, the medical device track—which offers greater room for efficacy claims—is emerging as a new path for anti-aging products.
For brands, shifting to the medical device registration track means:
- Greater room for efficacy claims
- Higher consumer trust
- Lower compliance risk
- Stronger competitive barriers
For OEM companies, entering the medical device registration track means:
- Higher business thresholds and profit margins
- A higher-quality client base
- Greater resilience to risk
- A more sustainable development model
The next big opportunity in the anti-aging market is already emerging on the medical device registration track.
Guangdong Weitai, leveraging its 78 Class II medical device registration certificates, 100,000-class cleanroom workshops, and four major production bases, offers brands one-stop OEM services for medical device-grade anti-aging products—from formula customization and registration certificate authorization to production and delivery.
From "botox in a bottle" to medical device-grade anti-aging, we are ready.
FAQ: Common Questions About Medical Device-Grade Anti-Aging Products
Q1: What is the difference between medical device-grade and cosmetic-grade anti-aging products?
A: The core difference lies in the scope of efficacy claims. Cosmetic-grade products can only claim "cleansing, protection, beautification, and grooming" and cannot claim medical effects; medical device-grade products can claim effects such as "helping improve wrinkles" and "skin repair," backed by registration certificates, offering stronger compliance.
Q2: How long does it take to obtain a Class II medical device registration certificate?
A: From product development initiation to certificate issuance, the cycle is approximately 12–18 months. This includes product registration testing, clinical validation (if required), registration application, technical review, and administrative approval.
Q3: Can OEM clients use your registration certificates?
A: Yes. We offer registration certificate authorization services. Brands can directly use our existing 78 Class II medical device registration certificates to bring products to market quickly.
Q4: Are the costs of medical device-grade anti-aging products very high?
A: Production costs for medical device-grade products are indeed higher than for cosmetic-grade products, mainly due to cleanroom facilities, quality systems, and registration certificate maintenance. However, since there is greater room for efficacy claims, there is also more pricing flexibility, and profit margins are typically better than those of cosmetic-grade products.
Q5: Which is more effective for wrinkle reduction: recombinant collagen or conotoxin peptide?
A: The two work through different mechanisms. Conotoxin peptide provides immediate wrinkle reduction by blocking neuromuscular signals, but it carries compliance risks; recombinant collagen achieves long-term anti-aging effects by supplementing structural proteins and stimulating collagen synthesis, with strong compliance and high safety. Looking at long-term trends, structure-rebuilding anti-aging is a more sustainable direction.
Data sources for this article: National Medical Products Administration, Regulations on the Supervision and Administration of Cosmetics, publicly available information from Vickey Technology, and Pinguan.com
For more information on medical device OEM manufacturing and registration certificate licensing services, please contact Guangdong Weitai Biotechnology Co., Ltd.
