DRAFT FOR COMMENTS: REQUIREMENTS FOR NEW IN VITRO DIAGNOSTIC MEDICAL DEVICES FOR SARS-COV-2
The Philippines Food and Drug Administration (FDA) is asking for input from manufacturers, traders, and distributors (importers/exporters/wholesalers) of IVD Medical Devices (IVDMDs) on the requirements for the Special Certification of new medical technology equipment and devices.
All new medical technology equipment and devices to be used for the diagnosis/screening, confirmatory, and monitoring/surveillance of SARS-CoV-2 infection shall require an FDA Special Certification prior to the manufacture, import, export, sale, or offer for sale.
Here are the requirements for the application of FDA Special Certification for emerging new IVDMD products for SARS-CoV-2 infection:
- Letter of intent
- Govt. issued certificate attesting to the status of the manufacturer’s competence, a Quality Systems Certificate of approval, or a compliance certificate for ISO 13485. If imported, the said document shall be accompanied by an original copy of a notarized declaration from the legal manufacturer or product owner.
- Original copy of a notarized declaration from the legal manufacturer or product owner for imported IVD, CPR, or any equivalent document issued by the National Regulatory Agency (NRA)/ accredited notified body in the country of origin.
- Clinical studies and performance evaluations are preferably conducted by National Regulatory Authorities or independent parties.
- Product profile
- Complete Product labels