Medical Device Registration Our in-house experts can offer the outstanding professional support in polishing the tailored ASEAN Common Submission Dossier Template (CSDT) and liaising with PFDA personnel to have your devices registered in the Philippines. ...
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.
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...
For the latest information regarding the medical device registration process in the Philippines, clickhere. Grow With Us Asia Actualspecializes in helping medical device manufacturers grow their sales in Asia with experienced, bi-lingual commercial and regulatory experts on the ground in each market. ...
Hangzhou Certificate Bidder Enterprise Management Co., Ltd. is a medical device registration company. It is an integrated service platform for medical device registration, clinical trial and licensing. The company provides customers with one-class medica
5 Common Medical Device Regulatory Compliance Problems Make all of your medical device creation processes easier with Qualio From conception to registration, Qualio can help throughout every step of the process of building and launching a medical device. Our quality management system was designed with...
FDA医疗器械注册网站(CDRH Medical Device Registration and Listing):https://www.fda.gov/medical-devices/device-registration-and-listing在这个网站上,您可以找到关于医疗器械注册和上市的信息,包括注册要求和指南。 请注意,这些网站可能只是FDA注册过程中的一部分资源,具体的注册要求和流程可能因产品类型、目的和其他...
21cfr part807.40(a)规定任何从事生产、准备、组合或加工成品医疗器械并将产品进口到美国的美国海外厂商都需要进行工厂注册(establishmentregistration)和医疗器械列示(medicaldevicelisting)。生产商在进行工厂注册时需要在注册列示系统(furls系统)以电子形式向fda申报美国代理人信息,包括的美国代理人信息包括姓名、地址、电话...
要进行电子阴道显微镜的FDA注册(FDA Medical Device Registration),需要满足以下条件和要求: 产品分类和风险等级:确定电子阴道显微镜的正确产品分类和风险等级,这将决定适用的预市通道和申请程序。产品分类和风险等级将基于器械的用途、设计特性、预期用途和潜在风险等因素确定。
The FDA Certificate of Product Registration (CPR) is a requirement if you plan to sell any of the following items in the Philippines: Food products (beverages, water, canned goods, etc.) Food Supplements Medicines, Over-The-Counter Drugs, and other Pharmaceutical products ...