In the Philippines, Medical Devices are regulated by Food and Drug Administration (FDA) under the Department of Health. Medical products whether they are manufactured or imported into the Philippines must be registered with the FDA. Medical devices in the Philippines are divided into 4 classes (1, 2, 3, and 4) based on risk level. To register a medical device, a company must have a local distributor in the Philippines registered with the Department of Health.

Our country specific (*) services in the Philippines include:

Medical Device specific regulation strategy reports, Medical Device Registration with the FDA, Philippian Representative and certification holder for Medical Device manufacturers, FDA Technical Dossier preparation and Arazy Group unique line of GlobaR - Global Regulatory Hub™ products.

GlobaR Dossier™
GlobaR - One World Process™
GlobaR Submission Center ™
Universal Authorized Representative™
 
Please fill in the following form and submit your inquiry or discuss it with one of our online specialists. Let's get your products registered in the Philippines!

(*) Philippian Regulatory Affairs services are part of the diverse professional consulting services provided by Arazy Group and can be found thorough this web site and inquired on through our form or online chat service.