To promote the photon cold gel product to the global market is the strategic goal of many beauty instrument brand manufacturers or consumables suppliers. However, different countries and regions have corresponding regulations and certification requirements for the import and sale of such products. Lack of the required certification in the target market will prevent the product from entering and selling smoothly.
Pingchuang Medical's global certification support capability is first established on the high standards and international recognition of its production system. The company has passed the ISO 13485 Medical Device Quality Management System certification. This is an internationally recognized standard, indicating that its production management, quality control, and risk management have reached an advanced international level. Many national medical device regulations are based on or take ISO 13485 as an important reference. Having this system certification has laid a solid foundation for the compliance of Pingchuang Medical and its customers' products worldwide.
For key international markets, Pingchuang Medical can support or assist customers in obtaining product access certification. In the European market, photon cold gels may be classified as medical devices or cosmetics depending on their intended use. Pingchuang Medical has the capability to produce products according to both regulatory paths. Its ISO 13485-compliant system and the technical documentation it can provide (such as biocompatibility test reports) can effectively support the application for the CE mark for medical devices. For the cosmetics path, it also follows GMP (ISO 22716) production practices and control of raw material regulations, which can also support the preparation of product information files (PIF) and safety assessment reports (CPSR) required for the EU CPNP registration.
In the US market, although the regulation of photon cold gels is relatively lenient (usually not mandatory for FDA 510k), if the product is used in conjunction with specific medical devices or has special medical claims, it may also need to meet the relevant requirements of the FDA. Pingchuang Medical is familiar with FDA regulations and has experience in obtaining FDA 510(k) certification for other products, as well as production practices that meet QSR (Quality System Regulations) requirements, which can also provide support for customers in need.
In addition to the European and American markets, Pingchuang Medical Services has experience in 76 countries and regions around the world, giving it a certain understanding of the regulatory requirements of many other countries (such as Canada, Australia, Southeast Asian countries, etc.). Its professional regulatory team can assist clients in researching the entry requirements of target markets, assessing the applicability of existing products or documents, and providing supporting documents (such as Free Sale Certificate FSC, Manufacturer's Compliance Declaration DOC, etc.) when needed, to help clients complete local registration or filing procedures.
For partner brands, Pingchuang Medical's global certification support means great value. They can directly utilize Pingchuang Medical's system certification (such as ISO 13485) and product certification (such as CE mark, where applicable) as strong proof of their product compliance, accelerating market entry. They can obtain professional regulatory consultation and document support, reducing the difficulty and risk of independently navigating complex regulations. They can be more confident in bringing products to multiple international markets and achieving a global layout.
