Why do Medical Devices Need to be Registered?
To engage in any of the following activities: manufacturing, importing, exporting, selling, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of health products— establishments, including retailers of medical devices—must obtain a License to Operate (LTO), according to the Food and Drug Administration (FDA).
As shown on their website, here’s the list of retailers covered by this FDA ordinance:
1. Retail stores for medical devices
2. Clinics that sell products classified as medical devices except those that are covered by the DOH One Stop Shop Licensing System
3. Sellers using online shopping websites, social media platforms, and/or TV shopping companies in selling or offering to sell medical devices directly to the general public
4. Operator of medical device vending machine
5. Optical shops
6. Drug outlets, such as drugstores, or boticas, and retail outlets for non-prescription drugs (RONPD) that also sell or offer to sell medical devices
But why does this matter? Here are the main reasons why medical devices need to be registered.
Here are 3 reasons to register your medical device
1. For safety reasons
Safety is paramount. Having your medical device registered ensures that it won’t produce unwanted side effects when used for the purpose it’s intended for, as outlined in its official instructions. Additionally, it eradicates the possibility of your device having any hidden toxic properties that can cause harm to people.
2. Quality assurance
Registering your medical device guarantees its quality once circulated in the market. Quality indicates that all set standards have been met and your device has the precise amount of active ingredient stated on the label. The device registration certifies the serviceability to maintain its therapeutic benefits, appearance, and efficacy for its prescribed shelf life.
3. Matter of efficacy
No one wants to have a bogus device to be used on them. Efficacy refers to your device’s ability to produce an intended outcome, specifically, the extent to which disease is prevented or treated in humans, or how it affects the anatomy or any function of an animal or human body.
Considering these, the registration ordinance ensures that your device is a tool for making a genuine difference in people’s health.
Want to register your device but don’t know how?
You will have to submit various documents that will help the government to inspect your device. For starters, take a look at this to know the fees you will need to pay the government:
Initial: ₱2,000.00 valid for 2 years
Renewal: ₱3,000.00 valid for 3 years
Fee for variation of LTO: ₱500.00
Legal Research Fee: additional 1%
Medical registration of devices can take time but you can speed up the process by partnering with Pharmacopoeia Consultancy. Our team of experts can walk you through each step, ensuring that your device reaches the market efficiently and compliantly.
Resources
https://www.fda.gov.ph/wp-content/uploads/2021/08/Bureau-Circular-No.-05-s.-1997.pdf
Noemi Moreno
