The beauty industry, especially the field involving the use of photoelectric equipment and related consumables, is facing increasingly stringent regulatory oversight from countries around the world. As a product that comes into direct contact with the skin and is related to energy transmission, the safety, labeling, ingredient use, and production conditions of photon cold gel may be subject to constraints under relevant regulations (such as medical device regulations, cosmetics regulations).
Brand owners and manufacturers must keep pace with and strictly comply with these regulations to ensure product compliance, avoid legal risks, and overcome market barriers. Pingchuang Medical Group attaches great importance to regulatory compliance and has established a comprehensive system to keep pace with the regulations of the beauty industry, ensuring the continuous production of compliant photon cold gel products.
The foundation of regulatory compliance is the accurate definition of product attributes. The regulatory classification of photon cold gel in different countries or regions may vary, depending on its intended use, claimed efficacy, and whether it is used in conjunction with specific medical devices. It may be considered a medical device (usually with a lower risk level) or a cosmetic. Pingchuang Medical's regulatory team will assist customers in accurately defining the attributes of the product based on its specific circumstances and the regulations of the target market, which is a prerequisite for following the correct regulatory path.
Continuous tracking and interpretation of regulatory updates is the core work. The regulations in the beauty industry (whether medical devices or cosmetics) are in a state of dynamic change. New lists of banned/limited ingredients, labeling requirements, testing methods standards, registration/filed procedures, etc., may be introduced continuously. The regulatory team of Pingchuang Medical closely monitors the official releases of the China NMPA, the European Commission (CE-related), the U.S. FDA, and other key markets through various channels, timely obtaining the latest regulatory information and providing professional interpretations, assessing their potential impact on the photoconductive gel products.
Integrating regulatory requirements into the entire product development and production process. During the formula development stage, the regulatory team reviews whether the raw materials to be used meet the regulatory requirements of the target market, avoids the use of banned substances, and ensures that the concentration of limited substances is within the permitted range. In the packaging design stage, it reviews whether the content of the label identification is complete, accurate, and compliant (such as ingredient lists, usage instructions, warnings, manufacturer information, certification marks, etc.). In the production process, it ensures that the production environment (100,000-level clean room), hygiene conditions, and quality management system (ISO 13485/ISO 22716) meet the requirements of the relevant regulations for production conditions.
Supporting necessary testing and certification. According to the regulatory requirements of the target market, Pingchuang Medical can carry out or assist customers in completing necessary safety tests (such as skin irritation, sensitization tests, based on relevant standards such as ISO 10993) and performance tests. It can also use its own internationally standardized system and technical document foundation to support customers in applying for the required market access certification (such as the CE mark) or completing registration/filed procedures (such as the EU CPNP notification).
Establishing a comprehensive record and traceability system. Following the GMP regulations, Pingchuang Medical maintains complete records of all stages of the production, inspection, and release of photoconductive gel. This is not only a requirement of the regulations themselves but also provides a basis for responding to possible market supervision inspections or product traceability.
Actively communicate with customers about compliance matters. When changes in regulations may affect customers' products, Pingchuang Medical will promptly notify customers and provide compliance advice. In ODM collaborations, the regulatory team will participate throughout the process to ensure that customized products meet regulatory requirements from the very beginning.
For brand owners and professionals in the beauty industry, compliance with regulations is a bottom line that cannot be touched. Choosing a partner like Pingchuang Medical, which actively keeps up with industry regulations, has professional interpretation capabilities, and integrates compliance into the entire product lifecycle, is crucial. Pingchuang Medical's commitment and practice to ensure the compliance of the photon cold gel products provides a solid guarantee for customers to operate safely and smoothly in the global market, allowing customers to focus more on their business development itself.
