With FDA Circular No. 2021-021, PFDA will start to regulate medical device retailers. Any establishment that sells or offers to sell medical devices directly to the general public fall is considered a medical device retailer. The regulation specified the establishments covered by the requirements, clarified licensing of drug outlets which are also medical device retailers, provided the specific requirements for qualified persons, and post-licensing inspections.
The scope of the regulation will be as follows:
The establishments above that are not required to secure an LTO can still, however, be held liable if found selling or offering to sell unregistered/unnotified medical devices. Other salient points of the guideline are listed below:
- 1. The requirements for the LTO, post-licensing, and qualified persons are as stipulated in AO No. 2020-0017.
- 2. Separate LTO will be required for drug retailers who are also engaged in medical device retail.
- 3. For retailers of ophthalmic lenses, prisms, contact lenses and their accessories and solutions, low vision aids, and similar appliances and devices wherein dispensing are governed by RA 8050 or the “Revised Optometry Law of 1995”, the Qualiﬁed Person shall be an optometrist.
- 4. The licensing fees will be ₱ 2,000 valid for 2 years for the initial application, ₱ 3,000 valid for 3 years for the renewal, and ₱ 500 for variation application. All of which will incur 1% legal research fee or ₱ 10, whichever is higher.
- 5. Only medical devices with CMDR or CMDN can be sold by the retailers.
- 6. Prescription medical devices shall only be sold when a valid prescription is presented. Ophthalmic products, as in item 3, can only be dispensed by a registered optometrist.
- 7. Online sale of prescription medical devices is not allowed. Advertisements are permissible provided that there are no links to the online purchase platform.
- 8. Retailers must immediately cease the sale of products that are been banned or withdrawn for health and safety issues in the country of origin and those that are declared by FDA to be unregistered, counterfeit, injurious, unsafe, or dangerous.
- 9. Medical device establishments that are already licensed by PFDA as manufacturers, importers, or distributors, but intending to sell to the general public must submit a minor variation application for additional activity.
Affected establishments are given two years from the effectiveness of the regulation to comply with these requirements. It is yet to take effect 15 days after publication in a major newspaper and upon filing 3 copies with the University of the Philippines Law Center.