In Perú, the General Directorate of Medicines, Supplies, and Drugs (DIGEMID) oversees the IVD and medical device market. This agency registers devices, issues operation licenses, inspects manufacturing facilities and warehouses, monitors product testing, and drafts policies and laws regarding medical devices imported to and sold in Perú.
Local regulations and medical device classification
DIGEMID classifies products into three main categories: supplies, medical devices, and IVDs. Bill 29459, Supreme Decree 019-97-SA, Supreme Decree 016-2011-SA, and associated amendments define the regulations for IVDs and medical devices.
Peruvian regulatory authorities group medical devices according to a four-tier classification system. This classification scheme determines our registration route. Ministerial Resolution 234 of 2017, title II, article 4, outlines medical devices classification in Perú. It includes devices class I, class II, class III, and IV. Devices further divide into active, invasive, and non-invasive.
In-vitro diagnostic device classification
The classification system for IVDs and medical devices is roughly the same. DIGEMID classifies IVDs into four classes, namely I, II, III, and IV, based on risk.
Product grouping
Regulatory authorities in Perú are not quite flexible on what we can put into a single registration application. There are vast criteria on what can be put together as a family of devices. Different types of devices can’t be grouped together. Devices sold by different manufacturers can’t be grouped together either. Grouping options depend much on the information existing in the Free Sale Certificate (FSC), CFG, and the product manual.
The role of the authorized representative
Before you begin the registration process, you’ll need to appoint a local representative, as Pharma Consulting, to communicate with DIGEMID on your behalf. This way, your company can maintain control over the registration. If a distributor is your in-country representative, they will list themself as the owner of the registration.
Registration timeframes
All registration applications are subject to review from regulatory authorities. Distributors must wait until formal review and approval are complete to begin importing and selling. Timeframes range from 1 to 6 months. If all goes according to plan, DIGEMID will issue a Directorial Resolution approving your device registration. The registration is valid for five years.
Source: Pharma Consulting
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