The Philippines regulatory system is currently in a transition period. Manufacturers will need to first determine whether their device is on the list of medical devices (FDA Circular 2014-005) requiring a Certificate of Product Registration (CPR) issued by the CDRRHR. If the product is not included in the list, the company shall classify the device based on the intended use and classification rules of the ASEAN Medical Device Directive (MDD). Typically, several factors can affect classification such as level of risk, delivery method, and the degree of invasiveness in the human body.
Products are classified into one of the following, from lowest to highest risk:
Additionally, Class A devices will apply for notification (a CMDN), while Classes B, C, and D will apply for registration (a CMDR). These are to be renewed every 5 years and are also listed on the Philippines FDA website.
Philippines Specific Cases
Certain medical devices that fall within the following categories are exempted from a CMDN or CMDR but still need a Medical Device Listing:
Donated and/or Novel
IVD are categorized separately from other medical devices and are further subdivided into one of the following, from lowest to highest risk:
Risk is determined by intended use, the expertise of the intended user, the importance of the resulting information of the diagnostic, and the impact of the test results. For example, a pregnancy test is Class B whereas an HIV Blood Test is Class D.
As the risk increases, more documentation may be required. For more details, contact Asia Actual.
Contact Asia Actual for more information about the Philippines classification system.
Guidance Document Name
Ministerial Regulations, Medical Device Products required Listing Approval
Outlines classification criteria for a Class 1, Listing category.