Us Fda Registration Services By Royalcert India
Price:
Get Latest Price
In Stock
Product Overview
Key Features
Compliance with US FDA regulations is the surest way to dramatically increase the value of your products and to expand to the global market.
However, the FDA can also cause serious financial consequences as well as irrevocable damages on the corporate image if not complied within a timely manner. Particularly the last year's imports alone, the FDA had refused more than 15,500 products from abroad, and this strict screening process is expected to continue.
QVC through our alliance partners assists medical device manufacturers seeking Food and Drug Administration (FDA) approval to sell their products in the United States. One of the first steps for medical device companies who manufacture Class 2 medical devices (and a small number of Class 1 and 3 devices) is to file a Premarket Notification, also known as a FDA 510(k) submission, with the Food and Drug Administration. Technically, the FDA does not "approve" Class 1 and 2 medical devices for sale in the US; they give "clearance" for them to be sold. To be cleared for sale by the FDA, the first step is to identify a Predicate Device(s), which is a medical device already cleared by the FDA and is similar to the one for which FDA approval is being sought.
In general, manufacturers introducing Class 2 medical devices to the US must submit a 510(k) to the FDA. A 510(k) is also required for manufacturers changing the intended use of their medical device.
However, the FDA can also cause serious financial consequences as well as irrevocable damages on the corporate image if not complied within a timely manner. Particularly the last year's imports alone, the FDA had refused more than 15,500 products from abroad, and this strict screening process is expected to continue.
QVC through our alliance partners assists medical device manufacturers seeking Food and Drug Administration (FDA) approval to sell their products in the United States. One of the first steps for medical device companies who manufacture Class 2 medical devices (and a small number of Class 1 and 3 devices) is to file a Premarket Notification, also known as a FDA 510(k) submission, with the Food and Drug Administration. Technically, the FDA does not "approve" Class 1 and 2 medical devices for sale in the US; they give "clearance" for them to be sold. To be cleared for sale by the FDA, the first step is to identify a Predicate Device(s), which is a medical device already cleared by the FDA and is similar to the one for which FDA approval is being sought.
In general, manufacturers introducing Class 2 medical devices to the US must submit a 510(k) to the FDA. A 510(k) is also required for manufacturers changing the intended use of their medical device.
Company Details
Royalcert India, Registered in 2013 at New Delhi in Delhi, is a leading service provider of ISO Certification Consultants in India. Royalcert India is one of Trade India's verified and trusted names for listed services. With extensive experience in the field of ISO Certification Consultants, Royalcert India has made a reputed name for itself in the market with satisfactory CE Marking Certification Services, GMP Certification Services, HACCP Certification Services, etc.
Focusing on a customer-centric approach, Royalcert India has a pan-India presence and caters to a huge consumer base throughout the country. Get ISO Certification Consultants from Royalcert India at Trade India quality-assured services.
Focusing on a customer-centric approach, Royalcert India has a pan-India presence and caters to a huge consumer base throughout the country. Get ISO Certification Consultants from Royalcert India at Trade India quality-assured services.
Business Type
Service Provider
Related Products
US FDA Registration - Comprehensive Service for Food and Drug Compliance | Prompt, Professional Support with No Hidden Charges
Cdg Inspection Ltd.
Mumbai, Maharashtra
Explore Related Categories
Seller Details
New Delhi, Delhi
Proprietor
Mrs. Nishi Shekhar
Address
Plot No-220, Jaina Tower 1,Near District Centre Janakpuri, New Delhi, Delhi, 110058, India
Report incorrect details
