The Philippines is a signatory to the ASEAN Cosmetic Directive (ACD), a regional agreement harmonizing cosmetic product regulations across ASEAN member states. The ACD ensures that cosmetic products within the region are safe, of high quality, and adhere to standardized labeling requirements. Key poin...
We will assist you with registering your food or drug product in the Philippines. We will also be involved in procuring forms for licensing and renewal of FDA permits/licenses.
Class B, C, and D devices. Three (3) months prior to the expiration of the CMDN, the local agent will need to apply for a CMDR and the issued CMDN and proof application for CMDR shall be provided at the point of entry and/or part of bidding requirements until the CMDR is ...
Given the high compliance requirements to the FDA 21 CFR part 11, not all document signing solutions can be used by organizations. However, GlobalSign’s cloud-based electronic signing solution called GMO Sign is compliant with all subsections of 21 CFR Part 11. What is GMO Sign and is ...
Obtaining a Certificate of Medical Device Registration (CMDR) from the FDA in the Philippines is a crucial step for individuals and companies involved in importing, distributing, and selling medical devices. By understanding the requirements, following the application process diligently, and complying wi...
Exporting Disinfectants to the US, What Should be Done Background As the epidemic continues, there is a shortage of disinfection supplies in many places around the world, such as the United States. In orde…
labeling. CaraAlfaro,Pharm.D. ClinicalAnalyst DivisionofPsychiatryProducts 10/27/2010 cc:Khin/Sohn/Laughren/Alfaro NDA#200603LurasidoneClinicalReview-AddendumPage5 ScheduleofActivities Thisisarepresentationofanelectronicrecordthatwassigned electronicallyandthispageisthemanifestationoftheelectronic signature. /s/ ...
Understanding New Cosmetic Notification, Labeling and Ingredient Regulation in China’s Taiwan Region China Pesticide Regulation and Registration Cosmetic Product Registration in the Philippines Made Easy: Regulations, Requirements and Practical Advice Chinese Drug Administration & Regulation System Chinese Drug ...
Description of measures to comply with safety requirements 在紧急情况下,可以在一种情况下使用、进口和/或制造未经官方营销授权的医疗器械。在这种情况下,DIGEMID必须给予制造商批准才能这样做。当迫切需要某一特定设备用于研究和培训目的或用于严重预防和个体治疗时,就会出现这种情况。 龙德可协助您完成秘鲁产品注册。