ISO 17065:2012 – PRODUCT CERTIFICATION BODIES ACCREDITATION What is ISO 17065? ISO 17065 is a Product Certification Bodies Accreditation Standard. As the name says it loud and clear, this standard is for the bodies that are certifying the quality of a product. The product can either be a physical one or some process or any […]
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ISO 17020:2012 – INSPECTION BODY What is ISO 17020? ISO 17020 conformity assessment requirements for the operation of varied sorts of bodies performing inspection are developed so as to create confidence within the inspection bodies. Accreditation to inspection bodies may be a procedure by which an authoritative body provides formal recognition of technical competence for
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ISO 17021-1:2015 – CERTIFICATION BODY What is ISO 17021-1? ISO 17021-1:2015 contains principles and requirements for the competence, consistency, and impartiality of bodies providing audit and certification of all types of management systems. Certification bodies operating to ISO 17021-1:2015 do not need to offer all types of management system certification. Certification of management systems is
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SASO/SABER Certification What is SASO/SABER Certification? The Saudi Standards, Metrology, and Quality Organization (SASO) is the national standards body of Saudi Arabia. It is responsible for developing, promoting, and maintaining national standards to ensure the quality and safety of products in the Kingdom of Saudi Arabia. SASO’s main goal is to enhance the competitiveness of
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Fairtrade Certification What is Fairtrade Certification? Fairtrade Certification is a product certification within the market-based movement fair trade. The most widely used fair trade certification is FLO International’s, the International Fairtrade Certification Mark, used in Europe, Africa, Asia, Australia and New Zealand. Fair Trade Certified Mark is the North American equivalent of the International Fairtrade Certification Mark. As of January 2011, there were over 1000 companies certified to the
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UKCA MARK CERTIFICATION What is UKCA Mark Certification? The United Kingdom Conformity Assessment Mark or UKCA Mark for short is the UK equivalent of the EU CE marking. UKCA Mark is a valid indicator that a medical device conforms to relevant UK Regulations. The United Kingdom Conformity Assessment (UKCA) marking is mandatory for medical devices
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US FDA 510K What is US FDA 510K? FDA Medical Device Classification is different from the EU MDR classification. The classification method and criteria also differ. FDA 510k device classification depends on the intended use and indications of the use of the device. The US FDA has established classifications for approximately 1700 different generic types of devices and
USA FDA COSMETIC REGISTRATION What is USA FDA Cosmetic Registration? FDA Cosmetic registration (VCRP) is voluntary. Manufacturers are not required to register their facilities nor their products with the US FDA. The FDA’s voluntary cosmetic registration program is for manufacturers, packers, and distributors of cosmetic products within the United States. VCRP is also called as Voluntary Cosmetic
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USA FDA DRUG REGISTRATION What is USA FDA Drug Registration? To obtain product DRUG approval, a firm must submit a New Drug Application (NDA), or an Abbreviated New Drug Application (ANDA) to the FDA. For OTC drugs, direct registration and listing are possible. Drugs sold over the counter without prescription are called over-the-counter (OTC) drugs.
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USA FDA DEVICE REGISTRATION What is USA FDA Device Registration? Foreign and domestic establishments such as (a) Manufactures (b) Initial Exporters (c) Initial Importers of Medical Devices intended to be sold in the USA must register and list with the FDA. It is mandatory to designate FDA US agents by establishments located outside the USA for better communication with the FDA
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