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1 day ago · Validity Extension of Existing License to Operate (LTO) / Certificate of Product Registration (CPR)/ Certificate of Notification (CPN) issued by the Food and Drug Administration (FDA) Download 2021
4 days ago · Current and valid DOH License to Operate, if hospital DSWD License to Operate and Certification of Accreditation, if non-government organization; and FDA Certificate of Product Registration (for medicines)
5 days ago · A Certificate of Product Registration (CPR) is a document issued by the fda license to operate that certifies the safety and efficacy of a medical device or product for commercial distribution in the Philippines. To obtain a CPR, businesses must submit detailed information about the product, including its composition, manufacturing process, and ...
4 days ago · Wait for the SEC to review the documents and issue the License to Do Business. 6. Obtaining Local Business Permits. Action: Secure necessary local government permits to operate legally. Process: Barangay Clearance: Apply for a Barangay Clearance from the barangay where the principal office is located.
1 day ago · The final FDA rule changes the paradigm. By explicitly defining LDTs as a type of in-vitro diagnostic tests, it becomes subject to FDA enforcement both pre- and post-market. The rule affects commercialization through requirements for an expanded level of evidence demonstrating safety and efficacy. Diagnostic manufacturers will need to consider ...
19 hours ago · 1. Classification of Medical Devices. The FDA classifies medical devices, including those used in aesthetic procedures, into three categories based on their risk level: Class I: Low-risk devices, such as tongue depressors and bandages. Class II: Moderate-risk devices, such as laser hair removal systems and some dermal fillers.
5 days ago · The new guidelines, which took effect on 13 January 2022, dubbed as Transportation Accreditation, Permits and Pass for Ports or TAPPP rationalizes the existing process in consideration of RA 11032 or the Ease of Doing Business and Efficient Gov't Service Delivery Act. TAPPP is recognized in all ports nationwide.
