All medical devices in the Philippines, whether manufactured outside or inside the country, should be registered with the Center for Device Regulation, Radiation, Health and Research(CDRRHR) of the Philippines Food and Drug Administration(FDA). All the medical devices available in the Philippines are classified and grouped into four different classes – Class A, Class B, Class C, and Class D.
The categorization of the devices is done based on medical risk; the lowest risk is classified as Class A and the highest is Class D. While Class B is for low to moderate risk, Class C is for moderate to high risk. While the registration of Class A medical devices is done through an online ‘e-notification portal system’, the registration of the other classes and IVD medical devices is done through an electronic mail system.
There are a few things that you should be aware of while registering medical devices with FDA Philippines and that is what we will be discussing in depth through this article.
Who Can Register Medical Devices In The Philippines?
License to Operate(LTO) is a mandatory document that any company should obtain in the Philippines to register a medical device with the country’s FDA. However, under the current circumstances, only the companies operating from within the country can apply for a License to Operate, which is problematic for foreign manufacturers. But there are a few ways through which the companies can overcome this issue. They are;
- Setting up a legal subsidiary entity
This is one way through which foreign manufacturers can obtain an LTO in the Philippines. While doing so, keep in mind the fact that the laws in the country demand a domestic corporation with more than 40% foreign equity to have a minimum capital of $2000,000. This method is also said to be quite complex and time-consuming.
This brings us to the second method, which is;
- Appointing a local distributor
You can also appoint a local distributor who has an LTO to regulate your medical devices in the country.
- Appointing an Independent third-party
This is yet another method that you can follow in order to register medical devices in the Philippines. Make sure that you find an independent third party in the country with a valid LTO to register your medical devices.
Documents required to register medical devices in the Philippines
Different documents are needed to require a medical device with the FDA of the Philippines. While the list is the same for almost all types of medical devices, it can differ in the case of medical devices for in-vitro diagnostics. Keeping that difference in mind, some of the general documents that are needed for almost all kinds of registration are;
- A device description
- Documents regarding any pre-clinical studios
- Device labelling
- Instructions for use
- Risk analysis
- Any kind of existing regulatory approval or market authorization
- Manufacturer’s compliance with ISO 13485
How to register medical devices with the FDA Philippines?
For medical devices that fall under Class A, the registration can be completed through the ‘e-notification portal system’ and for those falling under Class B, C, and D, the registration is completed via electronic mail. As for Class A medical devices, you will have to enter all the necessary details in the portal, which will undergo a pre-assessment. If all the documents are valid and acceptable, it will generate an order of payment. 5 days is the maximum time given to make the payment and complete the registration of the class A medical device.
As for mClass B, C, D, and IVD medical devices, you should make the payment once you receive an acknowledgment receipt via email. After the payment is made, the proof of the payment should be emailed so that the application is accepted. If all the documentation is correct, then the FDA CDRRHR will issue the Product Approval Licence which is also known as Market authorization.
Fee and timeline
You are expected to pay a fixed fee for all new medical device registration and going by the general trend, it will take anywhere between 6 to 9 months to complete a new registration. Also, if any additional documents need to be submitted, the FDA CDRRHR will allow an additional 30 days to submit them. Note that there are no additional fees levied for submitting extra documents.
Conclusion
So, if you are looking to register a medical device with the FDA Philippines, there are different agencies and consultancies that offer you easy and stress-free consultation and assistance with the process. However, it can also be done without the help of such agencies too, if you are ready to invest some time into the process. Also,. Make sure that you go through all the concerned official websites and be aware of the changes regarding the process after the pandemic, 9f any such changes are put in place.
