Customizing and developing self-branded photon cold gels through the ODM (Original Design Manufacturer) model is a choice for many beauty instrument brand manufacturers and salons. However, as a product that directly contacts the skin and interacts with photoelectric energy, the safety and regulatory compliance of photon cold gels are crucial.
Once safety issues or non-compliance with regulatory requirements arise, it not only harms consumer health but can also bring catastrophic consequences to the brand. So, how to ensure the safety and compliance of the final product during ODM cooperation? Choosing a partner like Pingchuang Medical, which has a sound quality system and regulatory awareness, and entrusting them to strictly control the quality, is the key.
The first line of defense for ensuring safety and compliance is the selection and control of raw materials. In ODM projects, whether the formula is specified by the customer or jointly developed, Pingchuang Medical insists on conducting strict safety assessments of all raw materials to be used. Priority is given to raw materials with a safe usage history and those that meet medical grade or high-quality cosmetic grade standards. Suppliers are subject to qualification audits, and incoming raw materials are inspected. For certain novel or special ingredients requested by the customer, a careful safety, stability, and regulatory compliance assessment is conducted to ensure that they do not pose potential risks and comply with the regulations of the target market (such as lists of prohibited/limited substances).
The second line of defense is the safety considerations in formula design. The research and development team at Pingchuang Medical always puts safety first in ODM formula design. In addition to raw material selection, they also pay attention to the compatibility stability between various ingredients to avoid the formation of harmful by-products; precisely control the pH value within the skin's suitable range; adopt a mild and effective preservative system and strictly control the concentration; strive for a simple formula and avoid unnecessary additives. For claims such as hypoallergenic or suitable for sensitive skin, more stringent formula review and necessary testing and verification are conducted.
The third line of defense is the strict control of the production process. The ODM photon cold gel products of Pingchuang Medical are produced in a 100,000-class clean room, following GMP operational specifications. Strict environmental control, personnel management, equipment cleaning and disinfection, and production process monitoring are implemented to maximize the prevention of product contamination by microorganisms or impurities during production. Standardized operational procedures ensure the stability and consistency of product quality between batches.
The fourth checkpoint is a comprehensive product inspection and release. For ODM customized products, Pingchuang Medical will also conduct strict factory inspections according to the preset quality standards. The inspection items cover appearance, physical and chemical indicators (pH, viscosity), and microbiological limits. For products that need to meet specific regulatory requirements (such as CE certification), additional tests such as biocompatibility tests (including cytotoxicity, skin irritation, sensitization tests, etc.) will be conducted or assisted in completing by the customer. Only when all inspection items are passed, the product will be released.
The fifth checkpoint is the review and support for regulatory compliance. Pingchuang Medical's regulatory team will participate in ODM projects, reviewing the formula ingredients, labeling, and promotional claims for regulatory compliance to ensure they meet the relevant regulatory requirements of the target market (such as China, the EU, the United States, etc.) (which may involve medical device or cosmetic regulations). Regulatory consulting can be provided to customers, and assistance can be offered in preparing relevant registration, filing, or certification documents when needed.
By establishing strict quality control mechanisms at multiple stages including raw materials, formula design, production process, product inspection, and regulatory compliance, Pingchuang Medical is committed to ensuring the safety and compliance of its ODM optical gel products. By choosing to collaborate with Pingchuang Medical for ODM, customers can entrust the responsibility of safety and compliance to a professional partner, thus focusing more on product market strategy and brand building without worrying about potential safety and regulatory risks. Pingchuang Medical takes care of the quality control, making your ODM journey more reassuring and smooth.
