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?
- Who Needs FDA Registration?
- 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 Food and Drug Administration (FDA) of the Philippines is the primary government agency responsible for protecting public health by ensuring the safety, quality, and efficacy of health-related products. The FDA carries out the licensing and monitoring of establishments involved in the manufacture, importation, distribution, and sale of regulated products.
Who Needs FDA Registration?
Businesses involved in the manufacture, importation, exportation, distribution, sale, promotion, transfer, or advertising of regulated health products in the Philippines may be required to comply with FDA requirements.
These products include food, food supplements, drugs, cosmetics, household/urban hazardous products, medical devices, and in-vitro diagnostic devices. FDA compliance generally applies at two levels:
- License to Operate (LTO): required for the business or establishment handling regulated products
- Product Registration or Notification: required for the product itself, depending on its classification, such as CPR, CMDN, CMDR, IVDR, or CPN
- In summary, a business may need an LTO, while the product it handles may separately require the appropriate FDA registration or notification.
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 on FDA Registration in the Philippines
Who needs FDA compliance in the Philippines?
Businesses that manufacture, import, export, distribute, sell, promote, transfer, or advertise regulated health products in the Philippines may need to comply with FDA requirements. This applies to both local and foreign entities, depending on their business activity and product type.
What products are regulated by the Philippine FDA?
The Philippine FDA regulates food, food supplements, drugs, cosmetics, household/urban hazardous products, medical devices, and in-vitro diagnostic devices. If your product falls under any of these categories, FDA compliance may be required before it can be introduced to the market.
What is the difference between a License to Operate (LTO) and product registration?
A License to Operate (LTO) applies to the business or establishment, while product registration or notification applies to the product itself. In many cases, a company must first secure the appropriate LTO before applying for a product-specific approval. Businesses should determine both the correct establishment license and the proper product authorization.
Do foreign companies need FDA approvals to sell products in the Philippines?
Yes, foreign companies seeking to introduce regulated products into the Philippine market may need FDA approvals, depending on the nature of their operations and products. This may include an LTO for the local establishment or authorized entity, as well as the relevant product registration or notification.
Do multiple products need separate FDA registrations?
Yes, in many cases, multiple products must be registered separately. Different variants, dosage strengths, or product presentations may require their own application and registration number.
How long are FDA licenses and product approvals valid?
Validity periods depend on the type of license or product authorization. Based on the webpage content, LTO validity may range from 1 to 2 years depending on the establishment type, while product approvals such as CPR and CPN have their own validity periods.