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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USA FDA FOOD REGISTRATION What is USA FDA Food Registration? USA Food Regulatory Agency of the Department of Health and Human Services has taken steps to protect the public from the food supply and related emergencies by enforcing the Bioterrorism Act from December 12, 2003. Must submit establishment registration information, with consent to inspect the
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WHO PQS CERTIFICATION What is WHO PQS? The WHO Performance, Quality, and Safety (PQS) process prequalifies products and devices so that member states and UN purchasing agencies are assured of their suitability for use in immunization programs. The PQS process also encourages a wide range of manufacturers to apply for prequalification so that a competitive marketplace
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FCC MARK CERTIFICATION What is FCC Mark? The FCC logo or the FCC mark is a voluntary mark employed on electronic products manufactured or sold in the United States which indicates that the electromagnetic radiation from the device is below the limits specified by the Federal Communications Commission and the manufacturer has followed the requirements of the Supplier’s Declaration of Conformity authorization procedures. The FCC label
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CSA CERTIFICATION What is CSA? The CSA Group (formerly the Canadian Standards Association; CSA) is a standards organization that develops standards in 57 areas. CSA publishes standards in print and electronic form and provides training and advisory services. CSA is composed of representatives from industry, government, and consumer groups. CSA began as the Canadian Engineering Standards Association (CESA) in 1919, federally chartered
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AYUSH STANDARD MARK What is Ayush Standard Mark? Quality Council of India has been engaged for voluntary certification of quality of Ayurveda Siddha Unani (ASU) products. Through this scheme, drug manufacturers are awarded the quality seal to the products on the basis of the third-party evaluation of the quality, subject to fulfillment of the regulatory
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