Food and Drug Administration (FDA) Registration Service
Obtaining FDA Registration in the Philippines is essential for businesses aiming to manufacture, import, export, market, sell, or distribute health-related products such as food, drugs, cosmetics, medical devices, and other health products. This process ensures that products meet the safety, efficacy, and quality standards set by the Food and Drug Administration (FDA).
Obtaining a License to Operate (LTO)
We begin by helping you obtain the required License to Operate (LTO), which is mandatory for legal operation under FDA regulations. This step ensures that your business is authorized to manufacture, import, or distribute FDA-regulated products in the Philippines.
Determining Product Type and Registration Requirements
We assist you in identifying the correct product category and the specific FDA registration certificate needed, such as the Certificate of Product Registration (CPR) or Certificate of Medical Device Registration (CMDR).
Document Preparation
We guide you in preparing all necessary documents required for submission, including application forms, product labels, certificates of analysis, and product samples, ensuring you meet FDA standards.
Registration on FDA’s Online Portal
Once documents are ready, we help you navigate the FDA’s eSubmissions Portal, submitting all required materials for pre-assessment and facilitating the application process efficiently.
Payment and Submission of Samples
We ensure that you make the necessary payments for registration and assist in submitting samples and laboratory test results if required, ensuring all FDA compliance standards are met before proceeding to evaluation and approval.
FDA Certificate of Product Registration (CPR) Issuance
If approved, you receive the FDA Certificate of Product Registration, allowing you to legally market and distribute your product in the Philippines. This official certification confirms your product’s compliance with FDA regulations.
Ensure your business meets all health and safety standards with FDA Registration!
We can simplify your FDA Registration process, ensuring your business meets all the requirements to operate legally in the Philippines. Whether you’re in the food, drug, cosmetic, or medical device industry, securing FDA approval opens the door to regulatory compliance and smooth market entry.
Specialized Knowledge
and Resources
We offer tailored consulting for industries with complex or rare licenses, leveraging our strong network and relationships to ensure a smooth approval process.
Cost-Effective
and Scalable Services
Our strong reputation with regulatory authorities and proven success ensure your secondary license applications are processed efficiently and without issues.
Comprehensive Reporting
and Documentation
We maintain clear communication with regular status updates and handle all documentation preparation and submission, ensuring accuracy and compliance.
Reputation and
Credibility
Our strong reputation with regulatory authorities and proven success ensure your license applications are processed efficiently and without issues.
FREE 30 MINS CONSULTATION
Ready to Process Your FDA Registration?
Get your FDA Registration with FilePino to ensure compliance with health and safety standards, making it easier than ever to bring your products to market in the Philippines.
FDA Registration FAQs
What is FDA Registration in the Philippines?
FDA Registration is the process of getting approval from the Food and Drug Administration (FDA) for businesses involved in manufacturing, importing, or distributing food, drugs, medical devices, or cosmetics in the Philippines.
Why is FDA Registration necessary?
FDA Registration ensures that products meet safety, quality, and regulatory standards, protecting consumers and allowing businesses to legally market their products in the Philippines.
What types of businesses need FDA Registration?
Businesses that manufacture, import, export, or distribute food, drugs, cosmetics, medical devices, or health supplements need FDA Registration.
What are the requirements for FDA Registration?
FDA Registration requirements typically include business permits, product information, manufacturing or importation licenses, quality control systems, and labelling compliance with FDA standards.
How long does FDA Registration take?
FDA Registration processing typically takes 2 to 3 months, depending on the complexity of the application and the completeness of submitted documents.
How much does FDA Registration cost?
The cost of FDA Registration varies depending on the type of product and the application fee set by the FDA. It’s important to consult the FDA website for specific fees.
What happens if a business fails to register with FDA?
Failure to register with the FDA can lead to penalties, fines, product seizures, or the suspension of business operations. It is crucial to comply with FDA regulations to avoid legal issues.
