In Peru, Medical Devices are regulated by the General Directorate of Medicines, Supplies and Drugs (DIGEMID) under the Ministry of Health. All products must be registered with DIGEMID before being marketed in Peru. Medical devices are divided into four classes (I, II, III, IV) based on risk level. To register a medical or IVD device, the manufacturer must have an office or a local distributor in Peru registered with the Ministry of Health.

Our country specific (*) services in Peru include:

Medical Device specific regulation strategy reports, Medical Device Registration with DIGEMID, Peruvian Representative and certification holder for Medical Device manufacturers, DIGEMID Technical dossier Preparation, GMP audit compliance 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 Peru!

(*) Peruvian 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 services.