Direct to Consumer Retailers will Have Additional Requirements

On October 7, 2021, the Philippines FDA released FDA Circular No.2021-0021 | Guidelines on the Licensing of Retailers of Medical Devices in the Philippines. The new regulations apply to establishments that provide medical devices Direct to Consumers (DTC) including pharmacies and eCommerce storefronts. These establishments will now need to apply for a License to Operate (LTO) and staff a qualified person in accordance with AO No. 2020-0017. Establishments already registered with the FDA will need to amend their LTO to include the activity of a “retailer.” The FDA-issued LTO will then need to be displayed inside the establishment.

Entities Affected by the New Requirements

Establishment such as retail stores, clinics (except “those covered by the one stop shop licensing system”), sellers of online shopping website, social media platforms and/or tv shopping companies, operator of medical device vending machines, optical shops, drug outlets, such as drugstores, or boticas, and retail outlets for non-prescription drugs (RONPD). This circular shall not cover grocery stores, supermarkets, convenience stores, chandler, kiosks and other similar stores (AO 2020-0017).

Fees at the time of publishing are as follows:

Do’s and Don’ts

The guidance reiterates that retailers are only allowed to sell registered medical devices intended for home use and with a Certificate of Medical Device Notification (CMDN) or Certificate of Medical Device Registration (CMDR). Retailers of prescription devices, such as pharmacies, must only sell to customers with valid prescriptions issued by an authorized professional. Retailers of ophthalmic lenses, prisms, contact lenses and their accessories and solutions, low vision aids, etc. governed by RA 8050 or the “Revised Optometry Law of 1995,” will need to have an optometrist as their Qualified Person. The Qualified Person will be responsible for handling Adverse Events, ensure that medical devices are issued with authorizations from FDA, ensure compliance of establishment, etc.

Online selling of prescription medical devices is prohibited. Retailers of these devices can advertisement online but are not allowed to let the consumer purchase directly. All retailers must immediately stop the sell of unlicensed medical devices that have been banned or declared unregistered or counterfeit by the FDA. Establishments found in violation of these regulations will be sanctioned in accordance with the Republic Act No. 9711.

Spot Checks

The FDA will from time to time conduct spot checks on establishments falling under these requirements and will expect to see the following upon arrival:

1. Proof of Business Name registration
2. Business Permit (if establishment address is different from business name registration address)
3. Credentials of qualified person:
   1. Valid PRC ID/ Diploma for those without Board Exam
   2. Certificate of attendance to seminars on medical devices given by the academe/ industry
4. SOP
5. Relevant reference materials (Issuances related to medical devices)
6. Valid LTO
7. Copies of CMDN or CMDR
8. Risk Management Plan

Grace Period

All existing retailers prior to the issuance of this Circular shall be given a period of two (2) years from the effectivity of this Circular to comply with the provisions thereof.

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Asia Actual specializes in helping medical device manufacturers grow their sales in Asia and with experienced, bi-lingual commercial and regulatory experts on the ground in each market. Contact Asia Actual today with any questions or support requests for the Philippines.