Healthcare has reached the trillion-dollar mark in the U.S. now. According to Statista, the entire U.S. healthcare industry will see a growth of 5% per year till 2024; and the fastest growing segments are MedTech and healthcare. No wonder why many businesses consider entering the U.S. to expand their market. However, medical businesses looking to enter the U.S. market need FDA registration to start with. Given the complexity of FDA registration and compliance issues, one can hire regulatory compliance consultants for FDA registration or take the DIY route. If you are not aware of FDA registration basics, read on!
FDA (Food and Drug Administration) Basics You Should Know:
- The FDA is a U.S. government agency and regulates various products, including food, human and animal drugs, vaccines, biological products, medical devices, cosmetics, health supplements, and tobacco products.
- The FDA works closely with manufacturers and may recall products it finds non-compliant with FDA rules and regulations and might issue safety communication to alert the public if there are adverse events.
- It is mandatory to register a business with the FDA if it involves manufacturing, repacking, or relabeling animal drug products and medical devices in the U.S. All domestic and foreign companies need to list all the drug products they market commercially.
Businesses That Require FDA Registration
FDA registration is mandatory for all domestic and Non-U.S establishments that
- Pack, prepare or process food products.
- Manufacture or assemble or sterilize medical devices.
- Involved in distribution, development, and processing of medical devices.
- Manufacture or repack drugs or relabel drugs.
- Manufacture tobacco products
All non-U.S medical businesses need to have a U.S. Agent for representing them in the U.S.
Why An FDA Registration Is A Must?
The FDA safeguards public health issues in the U.S. The agency’s responsibilities include:
- Protection of public health by securing the safety, usefulness, and security of human and animal drugs, medical devices, vaccines, and life science products.
- Informing the public with precise, science-based information ensuring the safe and appropriate use of medical products and foods
- Proper labeling of food products to ensure safety.
- Regulating and eliminating risks from radiating electronic products
- Regulating and ensuring the safety of tobacco products
Over 3 billion prescriptions are generated for pharmaceuticals each year in the U.S., and millions buy medical devices for health issues. Though medications and medical devices have their inherent risks, the FDA makes sure that risks are minimized and under control. An FDA registration keeps the companies under the FDA scanner. A registered establishment gets a unique registration number from FDA. FDA uses this number to track the business for inspections, exams, screening of imported products, and other activities. Therefore FDA registration is mandatory for medical establishments, U.S. or non-U.S. Without FDA registration, you won’t have legal permission to sell, distribute, import, or export FDA-regulated commodities.
Is It Easy To Get FDA Registration?
The FDA requires all registration and listing information to be submitted electronically. It is done in two steps. To register a medical device, you have to deposit the annual registration user fee. After paying the fee, you can complete the next step. For the newcomers, FDA rules and regulations may be overwhelming and confusing. Non-US manufacturers and exporters can consider seeking experts’ help for FDA registration. Regulatory compliance consultants are experienced experts and can guide you through the complex process of FDA registration by helping you with elements, the compulsory formats, and submission details. If you are struggling with FDA registration procedures, taking professional help will ensure you do things correctly and speed up the process.
How Long It Takes For FDA Registration?
FDA registration, when done through an FDA agent, can usually take 2/3 working days.
FDA Registration Is Not FDA Approval
There may be a misconception regarding FDA registration. Often, companies claim to sell medical devices carrying FDA registration certificates. But FDA does not issue registration certificates to registered companies.