*DIGEMID requires Certificates of Free Sale from recognized countries - France, Netherlands, UK, USA, Canada, Japan, Switzerland, Germany, Spain, Australia, Denmark, Italy, Norway, Belgium, Sweden, South Korea, Portugal, Ireland. If device does not have CFS from a recognized country, additional ispections might be required.
MDRC assists medical device companies worldwide with registration, representation, quality system compliance and distribution in Peru shown below.
Determining the proper classification for your medical device is critical to ensuring a smooth registration process. We have many years' experience with Peruvian medical device classification.
Companies without an establishment in Peru are required to appoint an authorized representative (Peru Registration Holder - PRH) as an in-country representative and liaison with DIGEMID. Having an independent firm control the registration for your device(s) is critical if you will not have a direct sales office in Peru. We will help you find a reliable Peru Registration Holder.
Technical File provides proof that your product is safe and effective. MDRC will prepare your Technical File in accordance with DIGEMID regulatory requirements. We will also advise you on device labeling requirements and IFU in accordance with Peruvian regulations.
While your registration is being finalized, our distribution specialists can help you find and evaluate Peruvian distributors. This will increase the chances of finding a partner who is qualified and able to effectively market your products in Peru.
| Validity | 5 years |
| Language | Documents and Labeling must be in Spanish |
| Postmarket Surveillance | Must report adverse events and device recalls. Post market studies |
| Expected Time | Class I devices: 60 days. Class II devices: 90 days. Class III and IV devices: 120 days. However, actual review time may be longer. |
*DIGEMID requires Certificates of Free Sale from recognized countries - France, Netherlands, UK, USA, Canada, Japan, Switzerland, Germany, Spain, Australia, Denmark, Italy, Norway, Belgium, Sweden, South Korea, Portugal, Ireland. If device does not have CFS from a recognized country, additional ispections might be required.
MDRC assists medical device companies worldwide with registration, representation, quality system compliance and distribution in Peru shown below.
Determining the proper classification for your medical device is critical to ensuring a smooth registration process. We have many years' experience with Peruvian medical device classification.
Companies without an establishment in Peru are required to appoint an authorized representative (Peru Registration Holder - PRH) as an in-country representative and liaison with DIGEMID. Having an independent firm control the registration for your device(s) is critical if you will not have a direct sales office in Peru. We will help you find a reliable Peru Registration Holder.
Technical File provides proof that your product is safe and effective. MDRC will prepare your Technical File in accordance with DIGEMID regulatory requirements. We will also advise you on device labeling requirements and IFU in accordance with Peruvian regulations.
While your registration is being finalized, our distribution specialists can help you find and evaluate Peruvian distributors. This will increase the chances of finding a partner who is qualified and able to effectively market your products in Peru.
