In Peru, the institution responsible for the regulation of medical devices is the Dirección General de Medicamentos, Insumos y Drogas (DIGEMID). Medical devices in Peru are classified into four different classes depending on their associated risk:
- Class I — Low risk medical devices
- Class II — Moderate risk medical devices
- Class III — High risk medical devices
- Class IV — Critical risk medical devices
With RegDesk Alerts you can always track changes and we warned when something changed in regulatory of Peru.
All medical devices must be registered with DIGEMID in order for manufacturers to be able to market them in Peru. The registration process takes about 4 to 5 months on average, although the exact length greatly depends on the classification of the device. Lower risk medical devices are usually approved more quickly, while devices associated with a higher risk tend to take longer. Once a registration application is approved, the registration certificate is valid for 5 years. If manufacturers intend to continue to market their device in Peru after this period, they are required to submit a renewal application.
For manufacturers that are based outside of Peru, it is also required to appoint an Authorized Representative, or a Peru Registration Holder (PRH), in order to successfully register a device with DIGEMID. PRHs handle medical device registrations and must be mentioned on the labels of the devices for which they are responsible.
Device manufacturers applying for registration in Peru must provide the following information:
- Detailed information regarding the device and its components
- Information on packaging and labeling
- All test results for the device
- Certificate of Free Sale (CFS) or Certificate to Foreign Government (CFG), if applicable
Under urgent conditions, it is possible to use, import, and/or manufacture medical devices without official marketing authorization under one condition. In this case, DIGEMID would have to give the manufacturer approval to do so. Situations like this occur when there is an urgent need for a given device for research and training purposes or for serious prevention and individual treatment.
Latest Regulatory Affairs Updates in Peru
On June 5, 2017, DIGEMID published a Decree (document is written in Spanish) that includes the following changes:
- Requirements for obtaining importation certificates for manufacturers have been simplified.
- Risk management reports for moderate to high risk medical devices are now required.
- Official review timeframes for all medical device classes have been lowered by 30 days.