Securing a License to Operate (LTO) from the Philippine Food and Drug Administration (FDA) is an important step for businesses dealing with medical products, such as drugs and medical devices. AO 2024-0015 has expanded the types of businesses that require an FDA LTO and made slight changes to the application process. Read more to discover what an FDA LTO for Medical Products is, the application requirements, and how to apply and renew your license.
Understanding the FDA LTO for Medical Products
The FDA’s License to Operate (LTO) is a mandatory authorization for businesses involved in manufacturing, importing, exporting, distributing, or selling medical products in the Philippines. Overseen by the FDA under the Department of Health, the LTO ensures that establishments meet safety, quality, and regulatory standards.
It’s not a personal license for healthcare professionals but a permit for facilities handling health products, such as drugs, medical devices, or in-vitro diagnostics.
What Businesses Require an FDA LTO for Medical Products
To operate legally, your business must obtain a Medical License to Operate (LTO) from the Philippine FDA if it engages in any of the following activities:
- Producing medical products: This includes manufacturing drugs, medical devices, or cosmetics locally, whether for widespread distribution or specialized medical purposes.
- Importing or exporting health products: This covers bringing regulated products into the Philippines or shipping them abroad, including bulk shipments for distribution.
- Wholesaling or distributing pharmaceuticals and medical supplies: This applies to businesses supplying hospitals, clinics, pharmacies, or retail outlets.
- Running a pharmacy or retail store: This includes independent drugstores or retail outlets within larger facilities selling FDA-regulated products.
- Operating online platforms selling regulated items: This encompasses e-commerce websites, social media sellers, or online marketplaces offering health products.
Since November 2024, Administrative Order 2024-0015 has expanded the scope of businesses requiring an FDA LTO, including:
- Dental laboratories: Facilities producing dentures, crowns, or orthodontic devices are now classified as medical device manufacturers.
- Optical laboratories: Businesses grinding, edging, or coating prescription lenses must now secure an LTO.
- 3D printing facilities: Companies using 3D printing to create medical device components, such as custom implants or prosthetics, are now under FDA regulation.
- Home test kit assemblers: Businesses assembling or repackaging diagnostic test kits are now considered manufacturers or repackers.
- Cold chain logistics providers: Third-party logistics firms managing temperature-sensitive FDA-regulated products must now obtain an LTO.
Even online businesses without physical storefronts must secure an LTO if they sell regulated products. Non-compliance can lead to penalties, including fines, business closure, or product seizure.
Application Requirements for FDA LTO Application
Requirements vary slightly depending on your business type (e.g., drug manufacturer vs. medical device distributor), but the core documents include:
- FDA e-Portal Account
Sign up your business and submit documents through the online e-Portal system. - Petition Form & Affidavit
Submit a fully completed, notarized form without any corrections or erasures. - Business Registration Proof (DTI/SEC)
Provide DTI registration for sole proprietorships or SEC documents for corporations/partnerships, including a Secretary’s Certificate if required. - Local Business Permit
Include a valid Mayor’s Permit reflecting the exact registered business name and address. - Franchise Documents (if applicable)
If relevant, submit the franchise agreement and proof of the franchisor’s registration. - Pharmacist Qualifications
Provide the pharmacist’s board certificate, PRC ID, PTR, list of duties, and FDA-accredited seminar certificates. - Product List
Detail all products, including both generic and brand names. - Proof of Premises
Submit a notarized lease agreement, ownership documents, or Certificate of Occupancy. - HOA Clearance (if applicable)
Include clearance from the homeowners’ association, if required for the location.
- Establishment Photo
Provide a clear photo of the business’s front exterior, displaying the registered business name. - Location Plan
Include a location sketch with landmarks and a floor plan with measurements. - Licensing Fees
Pay a base fee plus additional costs to cover inspection expenses.
Ensure all documents are uploaded in the PDF format. Although online applications are convenient, you must still ensure your requirements are complete, accurate, and fully compliant to avoid complications.
Applying via the FDA e-Portal
The FDA has streamlined the LTO process through its e-Portal. Here’s how to apply:
- Register for an FDA e-Portal Account
Input your business details and assign an authorized representative. - Compile Required Documents
Convert all documents to PDF, ensuring they are clear and, where needed, duly signed. - File Your Application Online
Log in to the FDA e-Portal, choose the appropriate application type (initial, renewal, or modification), and submit your documents with the required forms. - Pay the Application Fees
The system will issue a payment order, which you can settle via FDA-approved payment methods. - Undergo Facility Inspections (if required)
Manufacturers may face inspections to ensure compliance with standards like Good Manufacturing Practice (GMP) or Good Distribution Practice (GDP). - Complete Product Testing (if needed)
Manufacturers may need to submit products for laboratory tests to verify safety, quality, and efficacy. - Fulfill Additional Requirements (if applicable)
Extra steps or documents may be necessary based on your business type and operations. - Await FDA Assessment
The FDA will review your application and may request further clarification or additional documents. - Download Your Medical LTO
Once approved, retrieve your LTO from the e-Portal and consider printing it for display at your business location.
Business Registration Philippines can provide professional assistance by helping you gather the required documents and process your application.
Maintaining and Renewing Your FDA LTO
Once granted, your LTO isn’t a one-and-done deal. LTOs typically last 1–3 years before they must be renewed. For renewals:
- Submit Early: Apply at least 90 days before expiration via the e-Portal to avoid penalties.
- Update Documents: Provide updated financials, personnel records, and compliance reports.
- Pay Renewal Fees: Fees are similar to initial applications but may vary based on business scope.
Non-compliance, such as failing inspections or missing renewal deadlines, can lead to suspension or revocation.
Final Thoughts
Obtaining and maintaining an FDA License to Operate is required for any business involved in manufacturing, storing, and distributing medical products. Carefully check if your business needs this license, gather the required documentation based on your operations, apply on the e-Portal, and then receive your LTO. Don’t forget to renew it at least 90 days before its expiration date. If you have any questions or need assistance with your application, Business Registration is here to help.
Are You Applying for Your FDA License to Operate for Medical Products?
Securing all the legal requirements your business needs can be a complex and challenging process. With numerous permits and licenses required by different government agencies, it’s easy to miss a document or forget to renew it. Unfortunately, this can lead to costly fines or even force your operations to shut down.
Thankfully, the Business Registration Philippines team provides comprehensive support for your business registration, so you don’t have to stress over the paperwork. We’ll handle the applications and renewals so you can focus on what matters most – running your business and achieving financial success.
Contact us today to schedule an initial consultation with one of our experts:
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