Venezuela is the third largest medical device market in Latin America, following Brazil and Mexico, which makes understanding Venezuela’s medical device regulatory pathway crucial for MedTech companies expanding into Latin America (LATAM). Somewhat similar to Argentina, Venezuela’s medical device market is less developed than the two aforementioned LATAM countries, meaning that the regulatory approval process can be confusing for medical device companies seeking market access.
What is the Regulatory Body in Venezuela?
Venezuela’s regulatory body that oversees medical devices, including IVDs, is the Servicio Autónomo de Contraloría Sanitaria (SACS) as well as the Instituto Nacional de Higiene Rafael Rangel (INHRR). Both organizations are part of the larger regulatory body known as the Ministerio del Poder Popular para la Salud (MPPS). In 2005, Venezuela became a member of MERCOSUR, joining Brazil, Argentina, Paraguay, and Uruguay, however since 2017 its membership has been suspended indefinitely. Due to this change and general lack of alignment across LATAM countries, navigating Venezuela’s regulatory medical device pathway can prove to be challenging.
Key Info About Venezuela’s Medical Device Regulatory Pathway
Venezuela’s regulatory categorization for medical devices differs from ANVISA and ANMAT’s; instead of classifying the devices dependent on risk, Venezuela classifies its devices based on use. In addition, medical device manufacturers seeking market access in Venezuela must be certified and compliant with either ISO 9001 or 13485. The MPPS also holds authority to conduct audits and inspections of medical device importers at any time without prior notice.
The cost to register a medical device with the MPPS is outlined below:
|Classification||New Application Fee|
|Class I||1 Petro|
|Class II||1.5 Petro|
|Class III||1.75 Petro|
|Class IV||2 Petro|
Important Factors for MedTech Companies to Consider
For medical device companies seeking market access in Venezuela, there are some important factors to consider:
- Authorized Representative (AR): All foreign medical device manufacturers must have a local authorized representative (AR) to register any medical device, regardless of classification, in Venezuela.
- Spanish Translation: All documents and labelling must be submitted to Venezuela’s regulatory bodies in Spanish.
- Timeframe: Officially, Venezuela’s timeframe for reviewing new registrations for medical devices is approximately 20 business days, in reality the process can take upwards of 12 months.
- Validity: All devices registered with the MPPS are valid for 5 years.
- Local Currency: Venezuela requires all payments for medical device registration to be submitted in Petros Cryptocurrency. All monetary conversions must be conducted via a virtual Petro calculator on the same day of payment submission to SACS.
- Exemptions: If a medical device is imported by a MPPS accredited institution for testing, or requested by a MPPS accredited institution, not to be used for marketing purposes, then the device is exempt from registration.
While Venezuela’s medical device market holds ample opportunities for MedTech companies expanding into the LATAM region, it’s important for foreign manufacturers to understand the complex and constantly changing regulatory landscape. Medical devices companies unsure of where to start may benefit from partnering with a language service provider (LSP) to help navigate the translation process of the device labelling and documentations.