Medical Device (MD) registration is an administrative procedure whereby the National Regulatory Authority grants authorization for the nationwide marketing and distribution of a product, based on the assessment of the evidence supporting its quality, safety, and effectiveness. It is equivalent to marketing authorization.

MD registrations have a validity period of five years.

A medical device is any instrument, apparatus, implement, equipment, in vitro reagent or calibrator, software application, material, or another similar or related article, intended by the manufacturer for use in humans, alone or in combination, to one or more of the following specific purposes:

• Register your business as a pharmaceutical establishment (droguería): Establishments of manufacture, import, export, distribution, and commercialization must be registered with DIGEMID.

• Alternatively, you can appoint a Perú Registration Holder (PRH) as Pharma Consulting to manage your registration applications, and act on your behalf with our National Regulatory Authority. Click here to know more about our holder service.

Some class I medical devices, biomedical equipment, and orthopedic products are not subject to registration in our country. However, you need to obtain official authorization before marketing. Please contact us to get your products assessed.