Tiếng Việt
The Draft Decree on Cosmetics Management developed by the Ministry of Health signals a significant shift toward a more comprehensive regulatory framework, placing greater responsibility on businesses throughout the entire product lifecycle rather than focusing solely on pre-market notification procedures.
Key regulatory trends highlighted in the draft include:
▪ Strengthening digital management and centralized cosmetic product databases;
▪ Enhancing the responsibilities of Product Responsible Persons and companies placing products on the market with respect to product quality, safety, and regulatory documentation;
▪ Standardizing requirements for Product Information Files (PIF) and supporting quality documentation;
▪ Reinforcing post-market surveillance, product traceability, and risk management activities;
▪ Improving regulatory coordination between product notification, inspections, and market surveillance authorities.
📌 As regulatory expectations continue to evolve, businesses should focus not only on obtaining product notification approval but also on establishing robust compliance systems, maintaining complete technical documentation, and ensuring readiness for inspections and post-market regulatory reviews.
At Medgate, we support cosmetic companies throughout the entire regulatory compliance process, including:
🔹 Cosmetic product notification for imported and locally manufactured products
🔹 Preparation and review of Product Information Files (PIF)
🔹 Regulatory support for Power of Attorney (POA), Certificate of Free Sale (CFS), and manufacturer documentation
🔹 Assessment of Cosmetic Good Manufacturing Practice (CGMP) compliance documentation
🔹 Post-notification variations and regulatory maintenance
🔹 Labeling review, advertising compliance, and regulatory risk assessment
🔹 Support during inspections, post-market surveillance activities, and regulatory inquiries
Ensuring regulatory compliance from the outset can help businesses minimize regulatory risks, maintain market access, and support long-term business growth
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