PFDA updates its regulation on authorizations required for marketing PPEs, ventilators, and respirators with addition of importation guidelines. FDA Circular No. 2020-018 effectively repeals previous FDA Circular No. 2020-014. Apart from the LTO, importers and manufacturers of PPEs are now required to apply for notifications prior to sales and distribution whereas for ventilators and respirators, application for registration is only required once of the state of public health emergency in the country is lifted.
By August 26, 2020, all importers and manufacturers of medical devices used in the COVID-19 response previously allowed to market the said supplies without CPR or CMDN are required to submit corresponding applications. Otherwise, due regulatory sanctions will be incurred.
For customs release, LTO of the importer remains to be the sole requirement for PPEs, ventilators, and respirators for commercial use. Donations of the same items do not require customs clearance including masks that are strictly for company use.