PFDA recently released the list of regulated medical devices used for COVID-19 response included in the List of VAT- Exempt Health Products as per Republic Act No. 11534 or the CREATE Act. Stakeholders can access the list in this FDA Verification Portal List (Medical Devices Directly Used for COVID-19 Treatment).
CREATE Act was signed into law last 26 March 2021 as response to the COVID-19 pandemic. The law focused on amending the old tax code to lower corporate income taxes and provide financial incentives to better attract local and foreign investments. Among the provisions of this law is the VAT on the sale or importation of:
- drugs and medicines for cancer, mental illness, tuberculosis, and kidney diseases.
- equipment and raw materials to produce personal protective equipment for COVID-19 prevention; and
- all drugs, vaccines and medical devices used for the treatment of COVID-19.
For medical devices, the list of exempt medical devices contains 48 items falling into four categories:
The full financial implication of the regulation needs to thorough evaluation for each company to maximize the financial incentives stipulated by this issuance. You may consult our business and finance teams for this or check-out the following for more details: