FDA Eligibility for Your Business
The Food and Drug Administration (FDA) regulates a wide range of consumer products in the Philippines. If your business falls into any of the categories below, you’ll need to obtain the necessary FDA approvals.
Food and Beverages
Includes processed food, supplements, bottled drinks, and imported food items. Requires FDA registration for each product and an LTO for the business.
Drugs and Pharmaceuticals
Covers over-the-counter and prescription drugs, vaccines, and biologics. Requires Good Manufacturing Practice (GMP) Compliance, LTO, and product registrations.
Household or Urban Hazardous Substances
Includes cleaning products, disinfectants, and pest control items. Products must be properly labeled, tested, and registered with the FDA.
Cosmetic Products
Applies to skincare, makeup, fragrances, and other beauty products. Requires product notification with the FDA and compliance with labeling and safety guidelines.
Medical Devices
Covers a wide range from surgical instruments to diagnostic kits. Requires classification, registration, and FDA evaluation based on product risk level.
Toys and Childcare Products
Intended for items tailored towards children below 14 years old. Must meet safety and labeling standards, and register under the FDA’s Center for Device Regulation.
Types of FDA Certificates in the Philippines
The Philippine FDA issues different types of certificates depending on your business activities and product categories.
Certificate of Product Registration (CPR)
Required for regulated products such as food supplements, processed food, drugs, and household hazardous substances.
Certificate of Product Notification (CPN)
Applies to low-risk cosmetic products like lotions, lipsticks, and soaps. Instead of full registration, businesses submit a product notification to the FDA.
Certificate of Medical Device Registration (CMDR)
Issued for medical devices categorized as Class B to D, such as blood pressure monitors or surgical instruments. These devices require FDA evaluation and approval through CMDR before distribution or sale.
Requirements for a FDA-Licensed Product Holder
To register your products with the FDA in the Philippines, you must first decide on a product holder. This must be a locally registered company with an FDA License to Operate (LTO).
A. Register a Company
Set up a local entity to hold the License to Operate (LTO) and register products under your name. Your company must have the right business classification, meet FDA facility and documentation requirements.
B. Use Emerhub as the Licensed Product Holder
Emerhub can act as your FDA-licensed distributor, holding the LTO and registering products on your behalf.
C. Appoint a Local Exclusive Distributor
You can assign a single local distributor in the Philippines to hold the license and register your products. This is the simplest option but limits flexibility, as your product registrations and market access are tied to one distributor.
Not sure what’s the best choice for your company? Schedule a call to discuss it with one of our consultants.
FDA Registration Process with Emerhub
1
Initial Setup and Acquiring a License to Operate (LTO)
Before registering your products with the FDA, it is important for you to secure an FDA License to Operate (LTO). We’ll handle the LTO application process, from preparing documentation to coordinating with facilities so your operation meets FDA standards from the start.
2
Classifying Products and Compiling Documentation
Each product type will have different requirements and processes, so we will classify your products in line with the FDA’s specifications and gather all the necessary documentation, including technical specifications, labels, and certificates.
3
Registering on the ePortal
We’ll create your company’s ePortal account, update your information, submit your FDA application, and manage all submissions on your behalf, ensuring that everything is on track and properly managed.
4
Product Evaluation and Facility Inspection
Upon submission, the FDA will review your product information and conduct an inspection of your facilities. Our team will coordinate with the FDA officers and help address any complications or feedback to avoid any delays.
5
Certificate Issuance and Continued Compliance
After a successful evaluation, you’ll receive your Certificate of Product Registration (CPR). We will continue to provide support to help you remain compliant with the FDA’s regulations, including renewal timelines, labelling updates, and product recalls.
Have questions or need more information?
Why Partner with Emerhub for Your FDA Registration in the Philippines?
14 Years of Local Expertise
Backed by years of local regulatory expertise, we’ll help you navigate the complexities of FDA licensing and product registration with confidence.
On-the-Ground Support
With a team based in the Philippines, we’ll work closely with FDA regulators to keep your application on track and align with local expectations.
Trusted Professional Network
We work with experienced regulatory consultants, chemists, and legal professionals to ensure your products meet all technical and legal standards.
FAQs on FDA Registration in the Philippines
A foreign company cannot directly apply for FDA registration in the Philippines. They must appoint a local authorized distributor or establish a local entity in the Philippines to apply for FDA licenses.
An LTO’s validity depends on the size of the business, as follows:
- 3 years for small companies
- 6 years for medium-sized companies
- Up to 12 years for large companies (especially for medical device companies)
Yes, each formulation, flavor, packaging size, or variant generally requires a separate product registration from the FDA.
Yes, if you are an authorized distributor or importer with a valid LTO, you can register the product on behalf of the foreign manufacturer. This requires proper authorization with a distributor agreement or authorization letter.
A Certificate of Free Sale is a document that proves the product is legally sold or distributed in its country of origin and is required for imported product registrations in the Philippines.
Yes, if you are selling FDA-regulated products online, you will still need the proper licenses and product registrations. Online sellers must comply with the same regulations as physical stores.
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Schedule a call with an Emerhub consultant in the Philippines
Need help navigating FDA compliance in the Philippines? Share your product details with us, and we’ll guide you through every step.
Email Us
philippines@emerhub.com
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+63 945 726 2635
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