With the Philippines’ vast consumer market, you can seize growth opportunities in manufacturing, importing, exporting, and advertising your products. However, to ensure product safety and validate claims, registration with the FDA is essential.
- What is FDA?
- How to Apply for a License to Operate?
- How to Apply for a Certificate of Product Registration?
- How to Apply for a Certificate of Medical Device Notification and Certificate of Medical Device Notification
- How to Apply for a Cosmetic Product Notification?
- How Long is the Validity of the Licenses and Permits?
- What We Offer
- Frequently Asked Questions
Food and Drug Administration
The FDA is responsible for the licensing, monitoring, and regulation of the following products that will go out in the market:
- Food
- Food Supplements
- Drugs
- Cosmetics
- Household/Urban Hazardous Products
- Medical Devices
- In-Vitro Diagnostics
License To Operate (LTO) Application
Any establishment involved in the manufacture, importation, exportation, sale, distribution, transfer, promotion, or advertising of health products is required to secure an LTO from the FDA. This ensures that businesses are compliant with the regulatory standards set by the FDA.
Before introducing a product to the Philippine market, foreign entities must first review the FDA’s specific requirements for product certification. One of the initial steps is to obtain the LTO, a mandatory certification issued by the FDA that grants permission to operate within the country.
Depending on the nature of the business, an establishment must apply for the appropriate LTO, whether as an Importer, Distributor, Wholesaler, or Manufacturer.
After acquiring an LTO, the entity is required to apply for the following depending on the classification of the products they intend to introduce:
- Certificate of Product Registration (CPR) – Drug, Food, and Household/Urban Hazardous Product
- Certificate of Medical Device Notification (CMDN) / Certificate of Medical Device Registration (CMDR) / In-Vitro Diagnostic/Device Registration (IVDR)
- Cosmetic Product Notification (CPN)
Requirements for LTO Registration
When applying for a License to operate, it is necessary to prepare the following documentary requirements:
- Accomplished Application Form
- Proof of Business Registration
- Site Master File (for manufacturers of drugs, devices, and cosmetics)
- Risk Management Plan
- Proof of Payment of Fees
Certificate of Product Registration (CPR) Application
Before applying for a CPR, you must ensure that your company has successfully obtained an LTO. If you have multiple products to introduce, they must be registered individually based on their individual variant and dosage strengths, etc. These products will have their own registration number.
Requirements for CPR Application
An establishment must ensure to prepare the following documentary pre-requisites when applying for a CPR:
- Accomplished Application Form
- Clear and complete loose labels or artwork of all packaging sizes
- Pictures of the product from all angles
- If applicable, justification of label claims (i.e., nutritional facts, Halal logo, nutritional and health claims)
- Product sample in actual commercial presentation (for food supplements)
- Proof of payment of fees
Certificate of Medical Device Notification (CDMN) / Certificate of Medical Device Registration (CDMR) / In-Vitro Diagnostic/Device Registration (IVDR)
Registering a medical device with the Food and Drug Administration ensures that the device is safe, effective, and meets the required standards for use in the Philippine market. Registration for all categories of medical devices requires a License to Operate (LTO) from the FDA.
Requirements for CMDN/CMDR/IVDR Application
An entity must ensure to prepare the following documentary pre-requisites when applying for a CPR:
- Accomplished Application Form
- Clear and complete loose labels or artwork
- Pictures of the product from all angles
- Certificate of Analysis
- Proof of payment of fees
Cosmetic Product Notification (CPN) Application
CPN is almost similar to CPR, as this also requires a valid LTO. However, unlike the CPR, which applies to a wide range of products such as food and drugs, the CPN is specifically for establishments dealing with cosmetic products.
Requirements for CPN Application
Applying for Cosmetic Product Notifications requires several technical requirements, such as the following:
- Certificate of Manufacturer
- Certificate of Free Sale or Good Manufacturing Practice Certificate
Names, functions, and percentage of each ingredient in the product formulation - Clear and complete loose labels or artworks of all packaging sizes and commercial product packaging
- Proof of payment of fees
Product Licenses/Permits Renewal
You may renew your licenses/permits upon expiration. However, note that the validity of the licenses and permits that the FDA issues will depend on the product classification and registration.
Below are the duration of the initial licenses and permits product validity per classification:
License to Operate (LTO)
- Foods Establishment – 2 years
- Cosmetic Establishment – 1 year
- Medical Device Establishment – 2 years
- Drug Establishment – 2 years
Certificate of Product Registration (CPR)
- Foods – 5 years
- Food Supplements – 2 years
- Medical Devices – 1 year
- Drug Products 1 to 2 years
Cosmetic Product Notification (CPN)
- Cosmetic Products – 1 year
What We Offer
Our experienced FDA consultants are closely involved in product registration, classification, investigational device submissions, and procurement of forms for licensing. We will be able to help you with acquiring the following licenses/certificates from the FDA:
- License to Operate (LTO)
- Certificate of Product Registration (CPR)
- Cosmetic Product Notification (CPN)
- Certificate of Medical Device Notification (CDMN) / Certificate of Medical Device Registration (CDMR) / In-Vitro Diagnostic/Device Registration (IVDR)
- Variation of License to Operate (Major and Minor Variation)
- Variation of Product Registration (Drug, Food and Medical Device)
Aside from obtaining FDA licenses and certificates, our firm also helps with the renewal of permits/licenses and securing compliance with the FDA’s specifications on production facilities.
Frequently Asked Questions
What are the licenses and certificates foreign investors are required to obtain from the FDA in the Philippines?
Foreign investors and enterprises aiming to import, export, distribute, market, advertise, or manufacture regulated products in the Philippines must obtain the appropriate licenses and certificates from the Philippine Food and Drug Administration (FDA), depending on the nature of their business and the type of products involved. These include:
- License to Operate (LTO)
- Certificate of Product Registration (CPR)
- Cosmetic Product Notification (CPN)
- Certificate of Medical Device Notification (CDMN) / Certificate of Medical Device Registration (CDMR) / In-Vitro Diagnostic/Device Registration (IVDR)
What are the requirements for obtaining the license to operate (LTO) under FDA registration in the Philippines?
The requirements for obtaining the LTO under the FDA registration in the Philippines are the following:
- Accomplished Application Form
- Proof of Business Registration
- Site Master File (for manufacturers of drugs, devices, and cosmetics)
- Risk Management Plan
- Proof of payment of fees
When is the certificate of product registration (CPR) issued under the FDA registration in the Philippines?
The CPR under FDA registration is issued only to establishments with a valid LTO in the Philippines after submitting complete documents, passing evaluation, and meeting safety, quality, and efficacy standards.