- Monday May 22nd, 2017
- Posted by: pharmaconsultingperu
- Category: Legislacion
According to RD No. 033-2017-DIGEMID-DG-MINSA, published in March of this year, the Dirección General de Medicamentos, Insumos y Drogas – DIGEMID, has published a list of Medical Devices that can be directly marketed by Drugstores and Laboratories. This list does not list every medical device but establishes, based on its risk classification, whether it can be sold directly to patients, health care institutions (IPRESS), health care professionals or retailers.
During the training talks, DIGEMID officials clarified several points, including:
– Drugstores and Laboratories may directly sell Medical Devices of Class I, II, III, IV to health care institutions, health professionals and patients.
– Biomedical Equipments can be sold only to the health professionals and health care Institutions.
– Biomedical Equipments of Controlled Technology (Class III – High risk), can only be sold to health professionals and health care institutions.
– Commercial establishments (which are not authorized by DIGEMID, since they are not drugstores), can only sell non-sterile, low risk, Class I Medical Devices.
– In vitro diagnostic reagents may only be sold to health care institutions.
It is important to emphasize that the establishments must support these sales with the respective proof of payment (invoices or tickets); In the case of health professionals can be supported with a copy of the registration card or registration number that can be obtained through the website of professional colleges; In the case of patients, with a simple copy of a prescription.
Pharma Consulting provides consulting services in Regulatory Affairs, Good Storage Practices, Drugstore Implementation and Health Records Management to DIGEMID and DIGESA. For more information contact 997556699, 6830003 or visit our website www.pharmaconsulting.pe