FDA Registration

FDA Registration

FDA Registration

 was started to ensure medical product and food exported from the country are safe,of good quality, and are good and effective. FDA  registration activities in India include: fda registration

1.Inspecting medical products and foods  facilitities that get exported

2.Engaging with Indian regulatory authorities to build confidence and quality

3.Partnering with Indian counterpart agencies on bilateral initiatives

4.Assisting and training Indian regulators, Indian pharmaceutical and foods industries and stakeholders on developing and maintaining the quality, safety and effectiveness of medical products and foods

5.Building and strengthening relationships with the government of India by supporting the mission of the other countries as well. fda registration

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The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) directs the Food and Drug Administration (FDA), as the food regulatory agency of the Department of Health and Human Services, to take steps to protect the public from a threatened or actual terrorist attack on the U.S. food supply and other food-related emergencies. fda registrationfda registration

To carry out certain provisions of the Bioterrorism Act, FDA  registration established regulations requiring that:

  • Food facilities register with FDA, and fda registration
  • FDA be given advance notice on shipments of imported food.

These regulations became effective on December 12, 2003.fda registration

The FDA Food Safety Modernization Act (FSMA), enacted on January 4, 2011, amended section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), in relevant part, to require that facilities engaged in manufacturing, processing, packing, or holding food for consumption in the United States submit additional registration information to FDA, including an assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the FD&C Act.

 

Section 415 of the FD&C Act ,as amended by FSMA, also requires food facilities required to register with FDA to renew such registrations every other year, and provides FDA registration with authority to suspend the registration of a food facility in certain circumstances. Specifically, if FDA registration determines that food manufactured, processed, packed, received, or held by a registered food facility has a reasonable probability of causing serious adverse health consequences or death to humans or animals

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Online registration

Copyright filing requirements in India
Applicant’s particulars
-Name
-Address
-Citizenship
-For corporate entities
-Country of incorporation
-Nature of entity
Clear specimen of the work
-electronic form
-physical form
5 copies

Copyright particulars
-form
-Statement of particulars in triplicate
-Statement of further particulars in triplicate
-A no objection certificate
-Copyright notice
-Under certificate of posting
-Copy of work in triplicate
-Power of attorney

STEP 1
Check Eligibility

STEP 2
Central
SIGN UP has to be done by the FBO to create User name and Password

State
SIGN UP has to be done by the FBO to create User name and Password
FBO must have a valid Email id AND Mobile number to login as a GUEST user. Login details shall be created automatically by the system and mailed to the FBO

Registration
SIGN UP has to be done by the FBO to create User name and Password
Either valid email id OR Mobile Number is required to login. Login details shall be created automatically by the system and mailed/SMS to the FBO

STEP 3
Please read the fee structure/Payment Mode and supporting documents required list before filing application. The portal shall save all the information that you may capture till the time you have saved it. The application will saved as an INCOMPLETE APPLICATION. You can later on proceed the application to complete it.

STEP 4
Food Business Operator has to login in FLRS to apply for Renewal, Modification, Duplicate License /Registration Certificate. FBO can Surrender / transfer (only in case of death of License/fda Registration certificate holder) the License /Registration certificate without any fee with fda registration

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Establishment Registration
“Owners or operators of places of business (also called establishments or facilities) that are involved in the production and distribution of medical devices intended for use in the United States (U.S.) are required to register annually with the FDA registration . This process is known as establishment registration.

FDA form
http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM081806.pdf

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