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The Food and Drug Administration (USFDA) is a federal agency of the United States Department of Health and Human Services. FDA registration is the basic requirement for domestic and foreign organization who wants to manufacture or Sale Medical device, PPE`s, Food and Drugs in the USA. AMSPL helps you to get USFDA registration, provide guidance with FDA requirements for your industry specific products. Hereu2019s the complete process on how AMSPL helps in getting USFDA certification.
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AARANYA MANAGEMENT SERVICES PVT. LTD. USFDA CERTIFICATION USFDA CERTIFICATION FOR GLOBAL TRADE
The Food and Drug Administration (USFDA) is a federal agency of the United States Department of Health and Human Services.
The Food and Drug Administration (USFDA) is a federal agency of the United States Department of Health and Human Services. It provides FDA certification for products dealing in- 01 Medical Devices 02 Food and Agro products 03 Drugs 04 Cosmetics 05 Other FDA-Regulated Products
Who Needs USFDA Certification Companies who are involved in manufacturing, testing, packing, labeling, sterilization or import of medical devices are required to register their facility and list their devices with the FDA.
Process to get USFDA Certification 5 Steps to USFDA Certification 5 4 3 2 1 Upon successful, registration FDA will assign the operator number immediately.. Once the PCN is received, AMSPL will send you the draft medical device registration document for your review and approval After payment to the FDA, it will take about 5 to 6 business days for obtaining PCN (Payment Confirmation Number). The GDUFA cover sheet will have the PIN number and wire transfer details of the FDA After receipt of the completed medical device registration form, we will create a GDUFA cover sheet for making the FDA fee payment. It takes approximately 60 business days to obtain the registration number from the FDA after operation number is generated.
CONTACT US CORPORATE OFFICE B-1, Duggal colony,Khanpur, New Delhi – 110062 Mob:+91 98180 66855,+91 99539 86222 E-mail:info@aaranayacertification.com Visit our website for more details @ www.aaranyacertification.com BRANCH OFFICE #10, 1st cross, TCP Layout,Horamavu Agra Road, Horamavu,Bengaluru, Karnataka 560043 E-mail:office@aaranayacertification.com
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