Question 1

Can I export products even if I don’t have a local subsidiary?

Accepted Answer

Yes, VAVLON acts as your local importer in the Philippines and handles all legal obligations on your behalf, so you can export safely without having to establish a separate subsidiary or obtain a license.

Question 2

Do I need FDA approval to send samples?

Accepted Answer

Small quantities of non-commercial samples or samples for trade shows can be imported under a separate exemption procedure. The required documentation varies depending on the quantity and purpose, so we recommend consulting with us in advance.

Question 3

Why are both FDA certification and IOR required?

Accepted Answer

FDA certification is a prerequisite for local distribution and marketing, while IOR (Importer of Record) is a mandatory procedure to legally import products into the Philippines by acting as the importer for formal customs clearance.

Question 4

Can’t I get certified through an existing buyer?

Accepted Answer

Certification under a buyer’s name risks losing brand control, as the rights are vested in the buyer. VAVLON provides direct distribution infrastructure for your brand through a non-assignment agreement.

Question 5

How long does it take to obtain a CPN for cosmetics?

Accepted Answer

It generally takes about 25 to 30 business days (5 to 6 weeks) from the date of submission to the FDA.
This timeline is subject to change depending on local circumstances.

Question 6

Is the registration process the same for functional cosmetics?

Accepted Answer

The Philippines does not have a separate system for functional cosmetics, so the process is the same as for general cosmetics.
However, additional efficacy data may be required for certain claims.

Question 7

Do I need to redesign the product packaging?

Accepted Answer

Regulatory compliance can be achieved by affixing an overlay label sticker containing the required information to the existing packaging.

Question 8

We are planning to establish a Philippine subsidiary. Is it possible to transfer the certification we have already obtained?

Accepted Answer

According to FDA regulations, certification cannot be transferred. However, when establishing a local subsidiary, you can obtain a new certification under that entity.

Question 9

Are product labeling regulations strict?

Accepted Answer

Yes, they are very strict. English labeling is mandatory, and the list of ingredients, nutritional information, precautions, and importer information must strictly comply with Philippine FDA regulations.

Question 10

Is a shelf-life study required for food supplements?

Accepted Answer

Yes, you must submit research data that includes at least six months of data; Shelf life justification cannot be used.
This can be conducted cost-effectively through a local testing laboratory in the Philippines. (Please inquire separately.)

Question 11

Can we submit the product as a general food item instead of a food supplement?

Accepted Answer

The Philippine FDA distinguishes between general foods and dietary supplements based on the product’s form, method of consumption, and full list of ingredients.
Even if a product is registered as a general food in your country, it may be classified as a dietary supplement under local regulations.

Question 12

How are medical devices classified by class?

Accepted Answer

They are classified into four risk-based classes, A through D, with A representing the lowest risk and D the highest.
Classification criteria are defined based on the product’s functions, and the required documentation varies by class.

Question 13

Are beauty devices considered medical devices?

Accepted Answer

Devices equipped with functions such as LED, vibration, heat, or plasma are classified as Class B or C medical devices.
Beauty devices cannot be imported or distributed as general electronic devices.

Question 14

Is pesticide registered like cosmetics?

Accepted Answer

No. Household/urban pesticides (HUP) are hazardous-class products requiring an MSDS and efficacy data in addition.

Question 15

What is required for toy safety certification?

Accepted Answer

Test reports compliant with international safety standards (such as PNS/ISO 8124) are essential, and if the product contains PVC, phthalate test results must be included.

Question 16

What products are considered childcare products?

Accepted Answer

This refers to childcare products that come into direct contact with an infant’s mouth, such as baby bottles, sippy cups, rubber pacifiers, teething toys, and bottles.

Question 17

Do toys not intended for children also require certification?

Accepted Answer

For products intended for use by those 14 years of age or older, for personal collection, or for exhibition at trade shows and non-sale items, you can apply for a “Certificate of Exemption” to clear customs and distribute the products without certification.

Question 18

Do animal foods also require FDA registration?

Accepted Answer

No. Animal foods (such as feed and treats) fall under the jurisdiction of the Bureau of Animal Industry (BAI) within the Department of Agriculture, not the FDA, and follow a separate BAI registration process.

Question 19

What is the validity period of the certificate?

Accepted Answer

The validity period is up to one year, and the certificate expires on December 31 of each year, regardless of when during the year the certification is obtained.
Pre-applications for renewal for the following year can be submitted starting October 21 of the current year.

Question 20

Do music recordings (CDs, USB drives, etc.) require FDA certification?

Accepted Answer

No. Music recordings fall under the jurisdiction of the Optical Media Board (OMB), not the FDA, and require OMB approval for each shipment.

Question 21

Can I know duty rates in advance?

Accepted Answer

Yes, you can check the standard customs duty rate using the HS Code.
If there is a free trade agreement between your country and the Philippines, and you can provide proof of origin from your country, you may be eligible for preferential tariff treatment.

Question 22

How should I set the Commercial Invoice price?

Accepted Answer

If you have a buyer, set it to the supply contract price. For sales on platforms such as TikTok Shop or Shopee, we recommend setting it at 60–70% of the current market price to eliminate the risk of an undervaluation penalty.

Question 23

How much is the undervaluation penalty?

Accepted Answer

You must pay a penalty equal to 250% of the appropriate Commercial Invoice Value. Failure to pay may result in measures such as product seizure or destruction.

Question 24

How are the costs for import/export customs clearance paid?

Accepted Answer

We will invoice you in advance for the estimated costs (international freight, customs duties and taxes, all import/export clearance fees, IOR service fees + *20% contingency fee). Payment in USD or PHP is available.

Once all import/export procedures are completed, we will refund the remaining amount along with a settlement statement and relevant supporting documents.
Alternatively, you may choose to accumulate the remaining amount as a credit to use for your next export.

*The contingency fee is set aside to prevent customs delays in the event of unforeseen additional costs during the clearance process; any remaining balance will be fully refunded.

Question 25

How long does it take to ship via sea freight (LCL/FCL)?

Accepted Answer

For example, if shipment depart from Busan, Korea.

- Goods must be delivered to the Busan Port warehouse at least 3 business days prior to shipment
- Approximately 4 days from Busan to Manila
- Customs clearance takes approximately 5 business days on average
- Same-day delivery to the final destination after customs clearance

In total, you can expect the process to take about 3 weeks, including weekends, from the time the goods leave the manufacturer in Korea to their arrival at the final destination.
It is recommended that you prepare all import/export documents in advance before delivering the goods to the warehouse at Busan Port.

Question 26

How long does it take to ship by air?

Accepted Answer

For example, if shipment depart from Incheon, Korea.

- Delivered to the Incheon Airport warehouse at least 2 business days prior to shipment
- Takes approximately 4 hours from Busan to Manila
- Customs clearance takes approximately 7 business days on average
- Same-day delivery to the final destination after customs clearance

Taking all this into account, you can expect the process to take about 2.5 weeks, including weekends, from the time the goods leave the Korean manufacturer’s facility to their arrival at the final destination.
You must prepare all import/export documents in advance before delivering the goods to the Incheon Airport warehouse to prevent delays in customs clearance.
Since air freight is relatively more expensive than sea freight, we do not recommend it unless the shipment volume is very small.

Question 27

When are settlements deposited?

Accepted Answer

If the account was opened through VAVLON’s Philippine subsidiary, the funds will be remitted on a monthly basis after deducting the management fee.

Question 28

Can I use just the warehouse/fulfillment services separately?

Accepted Answer

For goods imported into the Philippines through official customs clearance, only warehouse and fulfillment services are available.
We are unable to provide services for smuggled goods.

How It Works

Diagnosis

Documentation & Strategy

Submission & Monitoring

Approval & Export

Required Documents

Cosmetics Required Documents

FAQ

Can I export products even if I don’t have a local subsidiary?

Do I need FDA approval to send samples?

Why are both FDA certification and IOR required?

Can’t I get certified through an existing buyer?