Peruvian Regulators Push for Reduced Medical Device Approval Timeframes
EMERGO SUMMARY OF KEY POINTS:
- Peruvian regulators are attempting to speed up medical device review and approval timeframes.
- DIGEMID has also updated regulations concerning distribution, clinical evaluation and risk management reports.
The Peruvian government has rolled out a raft of updates to the country’s medical device regulatory system, including an initiative to reduce approval timeframes for all device classes.
Issued by Peru’s medical device market regulator DIGEMID, the updates (link in Spanish) encompass not only review timeframes but also distribution, clinical trial and risk management reporting requirements.
Highlights of DIGEMID updates to Peruvian regulations
Notable among DIGEMID’s updates are the following:
- Reduced official review timeframes for all classes of devices by 30 days, resulting hopefully in faster reviews and approvals
- Simplified requirements for distributors to obtain importation certificates
- Removal of requirements for Peruvian market applicants to provide manufacturing flow charts and disposal method information in their registration documentation
- Acceptance of clinical trial reports in lieu of clinical trial data for higher-risk device applications (now part of formal Peruvian regulation)
- Required inclusion of risk management reports in medium- and high-risk device applications (now part of formal Peruvian regulation)