Peru Unveils Update to Device Registration Requirements
Peruvian health officials have amended regulations related to medical devices in a move that could prove beneficial for foreign and domestic manufacturers.
The Dirección General de Medicamentos, Insumos y Drogas, Peru’s medical device regulator, officially released a notice last month detailing the rules, including how manufacturers should make changes to their sanitary registration.
“Changes in medical devices with sanitary registration are classified in minor and major changes, according to the level of risk to the people’s health or their impact on the quality, safety and efficacy of the medical devices,” explains Maritza Reátegui-Valdiviezo, senior partner at Muñiz, Ramírez, Pérez-Taiman & Olaya.
For minor changes to the registration, companies need to send a notice to the country’s Autoridad Nacional de Productos Farmacéuticos, Dispositivos Médicos y Productos Sanitarios and implement the change within six months. If a major change is made, the company needs to send an application justifying the adjustment, as well as documentation backing up its request.
Reátegui-Valdiviezo,adds that minor changes would include a new company name, address of the sanitary registration holder, a different technical director or an updated taxpayer number.
Other minor complementary changes and major changes will be specified in a corresponding guideline pending with the Autoridad Nacional de Productos Farmacéuticos, Dispositivos Médicos y Productos Sanitarios
Reátegui-Valdiviezo, tells IDDM that the changes will prove beneficial to industry. “It facilitates the commercialization of the products, bearing in mind that products or devices with characteristics other than those authorized by DIGEMID may not be put in circulation.” She adds that sanctions for marketing a device with a different label than the one approved have been lowered from $12,000 to $3,600. — Elizabeth Hollis