BOC, FDA ease PPE import requirements

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The Bureau of Customs (BOC) said foreign donations of personal protective equipment (PPE) such as face masks, shoe covers, gloves, head covers and gowns are exempt from having to secure Food and Drug Administration (FDA) clearance.

According to FDA, BOC said other medical device establishments that use face masks in the performance of their duties and are strictly for company use are allowed to make direct importation without any certification from the FDA.

As a general rule, importers of all products are required to obtain appropriate marketing authorization from the FDA in the form of either a Certificate of Product Notification or Certificate of Product Registration (CPN/CPR), depending on the health risk of their products prior to customs release.

But BOC said the exemptions are being made in consideration of efforts to stop the coronavirus disease (COVID-19) outbreak in the Philippines.

Importations of PPEs for commercial purposes will be exempt from presentation of a CPN/CPR prior to customs release provided importers are able to provide a copy of the License to Operate and proof of application for product notification with the FDA.

BOC and FDA have assured that both agencies are prioritizing the expeditious facilitation of PPEs for donation and commercial purposes, the customs bureau said.

Aside from this, BOC earlier said it is already allowing provisional goods declaration for imported donations.

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21 COMMENTS

  1. Sir

    Good Day!

    I would to make an inquiry pertaining to the importation of PPEs nowadays. I am not a holder of any LTO for importation duly issued by your office. i am planning to import PPEs for my personal, duty work and family use this coming days. Do I need to apply this product of notification with your office? How and where do i need to transact?

    looking for your positive response on this matter.

    thank you and keep safe!

  2. Hello, I was about to open an import export company but was stopped by the ECQ. I want to import surgical mask, I have supplier,for commercial use. Is the customs completly free for surgical mask now how is there any taxes I still need to pay upon receiving the items in Manila airport? Unfortunatly I guess I will have to use an other company and share the profit for usimg their import licence.

  3. Hi

    What if i import a non medical mask like a reusbale cotton mask from
    China, 10,000pcs only what do i need to clear custom clearance in airport, its air freight shipment

  4. Hi, this was very informative. However i just wanted to proper understand in importing or ordering surgical masks in bulk.
    I was thinking to order 500pcs of surgical masks for personal use. Will there be any problems once i order it? Do i need any certificates and licenses for that? – planning to order from alibaba.

    Thank you in advance

  5. Good Day Sir,
    I’m planning to import face masks for business purposes, may I ask if there are any clearance needed by the BOC? Your reply is kindly appreciated. Thank you.

  7. We would like to renew oir Import license which expire last year.What is the
    process for renwal and what docs are needed?Thanks

  8. Hi may I ask if ever I will try to import face shield from overseas,do I need to present LTO?im a small time online seller only. I will order 70kg only

  9. Hello there Lisa. Thank you for your good work.
    I would like to ask if it’s allowed to import gloves, Face-mask and faceshield?

    Thank you again

    • Thanks, Thierry. Yes, imports of commodities you asked about are allowed. If you wait for the Bayanihan 2 Law to be signed by our President (which should be very, very soon), those commodities may be imported tax-free.

  10. May I also inquire if the only requirement for the said business purposes import of face shields, face mask and etc will require from FDA a Letter to Operate and accreditation from BOC?

Comments are closed.