Certifications

The FDA (U.S. Food and Drug Administration) certification is a critical approval process for products related to food, drugs, medical devices, cosmetics, and other consumer goods in the United States. It ensures that these products meet specific safety, efficacy, and quality standards before they can be marketed to the public. One Day Biotech continues to make efforts for strict quality control, through which it obtained FDA certification in 2020.

CE certification is a mandatory conformity mark for products sold within the European Economic Area (EEA). This indicates that the product meets the essential health, safety and environmental protection requirements established by European directives and regulations. The CE marking is recognized throughout the EEA and is often required for products sold outside the EEA. One Day Biotech is making continuous efforts for strict quality control, through which it obtained CE certification in 2021 and exports its products to 30 countries.

ISO certification refers to the process by which a company or organization is certified to meet the standards set by the International Organization for Standardization (ISO). ISO is an independent, non-governmental international organization that develops and publishes standards to ensure the quality, safety, efficiency and interoperability of products, services and systems across a variety of industries.

The term "GMP" stands for Good Manufacturing Practice, which refers to standards for the manufacturing and quality control of health functional foods. These standards ensure the production of safe and high-quality health functional foods that consumers can trust. GMP covers systematic guidelines for the entire process, from the structure and facilities of the workplace to the purchase of raw materials, production, packaging, and shipment, focusing on both production and quality.

The China NMPA Certification is an accreditation issued by the National Medical Products Administration (NMPA) of China. It authorizes the distribution and use of products such as pharmaceuticals, medical devices, cosmetics, and health supplements related to health and safety within the Chinese market. The certification evaluates the quality, safety, and efficacy of the products, which must comply with Chinese standards and regulations to be approved. NMPA certification goes beyond merely granting market access; it demonstrates that the products meet globally recognized quality standards, earning trust on an international scale.

The Ukraine Polytechmed Certification is a certification system that verifies that medical devices, pharmaceuticals, and health-related products meet the regulatory requirements and quality standards of Ukraine. This certification is a mandatory process for companies intending to manufacture, import, distribute, or use such products in Ukraine, ensuring their safety and efficacy.

The Thailand Medical Device Certification is a system implemented by the Thai Food and Drug Administration (TFDA), which operates under the Ministry of Public Health. It is required for the manufacture, import, and distribution of medical devices within Thailand. This certification confirms that the medical devices meet Thailand's legal requirements, ensuring their safety, quality, and performance.

The Taiwan QSD Certification is an accreditation issued by the Taiwan Food and Drug Administration (TFDA). It verifies that medical device manufacturers comply with Taiwan's regulatory requirements and maintain a quality management system. The QSD (Quality System Documentation) certification is a mandatory requirement for registering and distributing medical devices in the Taiwanese market. It ensures product safety and quality through rigorous evaluation.