{"id":26107,"date":"2023-01-05T15:46:11","date_gmt":"2023-01-05T14:46:11","guid":{"rendered":"https:\/\/www.thema-med.com\/?page_id=26107"},"modified":"2023-10-06T10:23:48","modified_gmt":"2023-10-06T08:23:48","slug":"medical-device-registration-venezuela","status":"publish","type":"page","link":"https:\/\/www.thema-med.com\/en\/medical-device-registration-venezuela\/","title":{"rendered":"Medical device registration in Venezuela"},"content":{"rendered":"
\"venezuela\"<\/span><\/div>
Regulatory Authority<\/b><\/h5>\n

1. Ministerio del Poder Popular para la Salud (MPPS); 2. Servicio Autonomo de Contraloria Sanitaria (SACS); 3. OICEMP. Medical Devices and IVDDs must be registered with the OICEMP.<\/p>\n

Classification<\/strong><\/h5>\n

There is no risk-based device classification. Devices are classified according to the use categories.<\/p>\n

Quality system<\/b><\/h5>\n

ISO 13485:2016:2016 or ISO 9001<\/p>\n

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<\/i><\/span>The information on this page is valid and current as of January 2017. The legislative and regulatory provisions are subject to changes and updates by the Regulatory Authorities of the State to which they refer. Considering the above, the writer declines all responsibility regarding any non-actuality and\/or inaccuracy of the information received concurrently with or following the publication of this page Disclaimer<\/a><\/strong><\/em><\/span><\/div><\/div><\/div><\/div>

Some Medical Devices are exempt from registration, in particular: \u2013 devices imported into the country for testing by an accredited institute; \u2013 devices for research \/ study purposes, if requested by accredited institutions; \u2013 exhibition devices, not intended for marketing. All other Medical Devices must be registered with the OICEMP. Foreign manufacturers intending to market Medical Devices and \/ or custom-made devices in Venezuela must appoint a Local Representative responsible for submitting the documents required in the registration procedure to the OICEMP.<\/p>\n

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Applicant<\/span><\/h3>\n

Local Authorized Representative<\/p>\n

Timeframe and fee<\/span>s<\/span><\/h3>\n

Timeframe: 1- 12 months Fees: no registration fee is provided. Validity<\/span> 5 years<\/p>\n

Labelling and documentation language<\/span><\/h3>\n

Documentation and labelling must be submitted in Spanish.<\/p>\n

Useful information<\/span><\/h3>\n

The device which already obtained the FDA marketing clearance will be subject to a facilitated registration process to access the Venezuela market.<\/p>\n<\/div><\/div><\/div><\/div><\/div>

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    Do you want to market your Medical Device in this Country? Contact us!\n<\/h3>\n