Reminder on unauthorized online sale and distribution of health products
In the midst of the COVID-19 situation, there is a whole spectrum of health products sold in different online platforms meant for the mitigation of the pandemic. Last March 20, 2020, PFDA issued FDA Circular No. 2020-010 entitled “Prohibition of Online Selling of Unregistered/ Unnotified Medical Devices”. This is a reminder to the public to make sure that the health product or medical device they are purchasing has proper authorization from FDA through the product CPR, CMDR or CMDN and establishment’s license to operate (LTO). This circular also instructs all FDA Regional Field Offices and Regulatory Enforcement Units to deliver due diligence by exhaustive monitoring of all online platforms to ensure full compliance of this circular. Immediate regulatory and enforcement actions must be taken as necessary. The public can also report the sale or distribution of unregistered medical device through the online reporting facility, eReport, which can be accessed at www.fda.gov.ph/ereport.
Manufacture of PPEs, Ventilators and Respirators within and after the Duration of the COVID-19 Pandemic
FDA Circular No. 2020-014, entitled “Interim Guidelines on the Manufacture of Personal Protective Equipment (PPE), Ventilators, and Respirators in Light of COVID-19 Situation” was released last April 8, 2020. This tackles the authorization on the sales and distribution of the said supplies before and after the COVID-19 situation.
Interested manufacturers must possess an LTO as a medical device manufacturer from PFDA as per AO 2016-003 (guidance for LTO application). FDA Circular No. 2020-006 and 006A emphasized that transactions related to COVID-19 response will be prioritized including LTO application. With a valid LTO, the manufacturer can now supply PPEs, ventilators, and respirators without the need to apply for a CMDR or CMDN within the duration of the pandemic.
The manufacture of the said supplies must be guided by the Philippine National Standards or applicable international standards such as ISO or IEC. Testing of the finished product to shall be done by the appropriate accredited laboratory by the Philippine Accreditation Bureau to ensure the quality and safety.
After lifting of the State of Public Health Emergency throughout the Philippines and manufacturer decides to continue to manufacture the aforementioned supplies for commercial use, their products will need to apply for a CMDN or CMDR to PFDA within three (3) months.
1. FDA Circular No. 2020-010