Medical Device Product Manufacture Approval

In accordance with Article 6 of the Medical Device Act, the medical device manufacturer must be audited for intended product manufacture approval, and appropriate facilities and a quality control system. Since BionTech acquired the 889th manufacturing business license in 2000, the BionTech has obtained 28 alkaline Water Ionizer product licenses by 2014.

US Food and Drug Administration Medical Device Manufacturer and Device Registration

FDA Center of Device and Radiological Health (CODH) in the United States oversees and regulates the pre market approval for the medical devices within the United States. All medical device manufacturers, distributors, and importers must be approved and certified by FDA. BionTech has been approved in 2005, and registered all of its Water Ionizers products.

Medical Device Manufactur & Quality Control Standard Certified

Medical device GMP (Good Manufacturing Practice) is a system that ensures manufactur and sales of outstanding, quality-guaranteed products, through regulating equipments relate to overall manufacturing process including facility structure and equipment, purchase of materials, designing, manufacturing, packagin, and installing of the product. BionTech first obtained the certification in 2005, and has been maintaining certificate's effectiveness through 3-stage regular audits.

Quality Management System

ISO (International Organisation of Standardization) 9001 addresses quality management by providing quality certification standard. An independent certification party objectively performs audits to check how each product and service provided to customers has satisfied basic requirement, and thereby verifies the product's credibility. BionTech was certified in 2008.

Environment Management System

ISO 14001 addresses environmental management by setting criteria for an environment management system that can evaluate how eco-friendly and effective each company's harmful elements and to control their environmental impact during the manufacturLing process. BionTech was certified in 2008.

Custom Approved Registered Exporter

The Customs Act for the Implementation of Free Trade Agreements is a system in which the Customs provides simplified process of certificate issuance for those exporters whose satisfaction of Preference Criterion regarding the export goods have been verified, in accordance with Paragraph 2, Article 7 of the Enforcement Rule of the Act on Special cases of the Customs Act. BionTech obtained product category certification in 2013.

European Conformity Certified

CE mark is a mandatory conformity certification marking for products exported to EU (European Union) member countries, in accordance with EU regulations, CE marking of a product shows that the product complies with each EU country's certificatin systems and technology regulations regarding safet, health, environment and protection of consumers. BionTech obtained the product category certification in 1998, and every new products exported to Europe mandatorily have CE marking.

North America Electrical and Electronic Product Safety Certified

NRTL (Nationally Recognized Testing Laborator) program is a part of OSHA (Occupational Safety and Health Administration) regulation that provides safety standards for products in North America. The NRTL's mark on the product assures the user that the specific product complies to minimum requirements for electric product safety standards in North America, and it has been simplified to one NRT-marks after the North American Free Trade Agreement (NAFTA). Biontech obtained the product category and NRT certificates in 1998, and has been maintaining the certificate through regular audits. 

International Electrotechnical Commission for Electrical Equipment Certified

Established and operated by IECEE (International Electrotechnical Commission for Electrical Equipment), CB schemes multilateral agreement for international certification of electrical and electronic product. A single safety certification in accordance with IEC international standards in a member country is mutually recognised by among the member countries. Many countries centred around Europe has adopted IEC standard as national safety standards, and BionTech obtained product category certificate in 2010.

German Certification

Japan PSE (Product Safety Electrical Appliance & Materials) Certified

PSE certification is a mandatory conformity assessment conducted under Japanese Electrical Appliance and Material Safety Law, managed by the Ministry of Economy, Trade and Industry of Japan. A person who manufactures or imports applicable products with intention of exporting to Japan must verify that the specific product satisfies related safety standards and regulations, and obtain PSE mark accordingly. BionTech obtained PSE DIAMOND certificate in 2006.