Peru Blog Posts

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.
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Peru Amends, Formalizes Medical Device Regulations

DIGEMID, Peru’s medical device market regulator, has published amendments to the country’s law covering pharmaceutical and device regulatory requirements that better reflect guidelines of the International Medical Device Regulators Forum, or IMDRF.

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Peruvian Regulators Place New Requirements on Medical Devices with PVC Components

DIGEMID, Peru’s medical device market regulatory agency, has rolled out new disclosure and labeling rules for medical devices that contain polyvinyl chloride (PVC) or PVC that contains DEHP (di-(2-ethylhexyl)phthalate).

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