Regulatory Authority: Dirección General de Medicamentos, Insumos y Drogas (DIGEMID).
Classification system: Regulated by the Medical Device Classification List PE-006. Risk-based. Classes I, II, III and IV.
Authorized Representative: Peru Registration Holder (PRH). Required for all classes
License Validity: 5 years.
Timeframe: The approval process takes about 5-8 months.
Notes: Major regulations - Nº 016-2013-SA, Law No. 29459, No.001-2012-SA. Radioanalysis devices must receive additional authorization from the Nuclear Regulatory Authority.
Regulatory Authority: Agencia Nacional de Regulación, Control y Vigilancia Sanitaria (ARCSA).
Classification system: Risk-based. Classes I, IIa, IIb and III.
Authorized Representative: Required for all classes.
License Validity: 5 years
Timeframe: 2-6 months
Notes: Resolution ARCSA-DE-030-2018-JCGO, amends Resolution ARCSA-DE-026-2016-YMIH (regulation on registration and control of medical devices), with a simplified route for Class I and II devices with registration in a recognized country (US/CAN/AUS/JP/SKR/EU).
Regulatory Authority: Ministerio de Salud.
Classification system: Regulation No. 34482-S. Risk-based. Classes 1, 2, 3 and 4.
Authorized Representative: Costa Rica Registration Holder. Required for all classes except class I.
License Validity: 5 years
Timeframe: 6-8 months. Review timelines depend on the class of the device.
Notes: Class 1 devices do not require registration prior to import or commercialization per Decree 41387-S. Class 1 devices must still fulfill the minimum safety and efficacy requirements set forth in Decree 39342-S, including post-market vigilance and adverse event reporting. If your medical device has FDA 510(k) clearance or premarket approval, and you can obtain a CFG from the FDA, your device will qualify for an abbreviated registration process.
Regulatory Authority: Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA).
Classification system: Set forth in Chapter II of Decree 4725/2005. Risk-based. Classes I, IIa, IIb and III.
Authorized Representative: Colombia Legal Representative. Required for all classes.
License Validity: Valid for 10 years, but there are exceptions.
Timeframe: Class I and IIa device should take less than 1 month. Class IIb and III devices may take up to 6 months.
Notes: INVIMA automatically approves Class I and IIa applications, so you may begin selling right away. The agency will still review the application, and manufacturers must respond to any additional information requests within 30 days. Failure to comply will result in approval being revoked. For Class IIb and Class III devices, INVIMA must review and approve your application before you can begin selling; the review could take 4-6 months. During this review they may ask follow-up questions or request additional information. INVIMA may choose to audit your submission and request more documents, which will add time to your approval.
Regulatory Authority: Ministerio de Salud (MINSA).
Classification system: Risk-based. Classes I, IIa, IIb, III and IV.
Authorized Representative: Required for all classes.
License Validity: 5 years.
Timeframe: 2-6 months.
Notes: An additional technical file is required to register a product that is new to Panama.
Regulatory Authority: Instituto de Salud Pública (ISP).
Classification system: Risk-based. Classes I, II, III and IV.
Authorized Representative: Required for all classes
License Validity: Valid until the expiry of the device’s first relevant certificate.
Timeframe: 2-3 months. IVD devices require local testing, which can take up to one year.
Notes: According to the Sanitary Code and Decree 825/98, the regulation of medical devices will be done progressively, via specific Supreme Decrees signed by the Ministry of Health. This specific Decrees specify the devices' Class and so the regulatory controls and requisites that apply to them.
Regulatory Authority: Direccion de Viglancia Sanitaria del Ministerio de Salud Publica y Bienestar Social (MSPBS).
Classification system: No national medical device classification has been implemented. Medical device companies should reference to Mercosur classification.
Authorized Representative: Required for all classes
License Validity: 5 years
Timeframe: Defined on case by case basis.
Notes: Paraguay is a member of Mercosur. All medical devices intended to be marketed in Paraguay should be compliant with MSPBS regulations and Mercosur guidelines.
Regulatory Authority: Dirección Nacional de Medicina (DNM)
Classification system: Risk-based. Classes I, IIa, IIb and III.
Authorized Representative: Required for all classes
License Validity: 5 years
Timeframe: Defined on case by case basis
Notes: Ionizing radiation devices or equipment require an import permit from the Radiation Protection Directorate at the Ministry of Health.
Regulatory Authority: Ministerio de Salud Publica (MSP)
Classification system: Categories 1, 2, 3, 4, 5, 6
Authorized Representative: Required for all classes
License Validity: 5 years
Timeframe: 6-12 months
Notes: Uruguay is a part of Mercosur (Common Southern Market). Mercosur defines Technical Regulation for medical device registration. For the most part Uruguay's regulations are harmonized.
Regulatory Authority: Ministerio de Salud. Unidad de Medicamentos y Acreditación de Laboratorios (UNIMED).
Classification system: Classes I-IV.
Authorized Representative: Required for all classes.
License Validity: 5 years.
Timeframe: 6-12 months.
Notes: The health ministry’s medical device manual, the “Manual Dispositivos Médicos”, as well as the Manual of Sanitary Registration provide specific guidance on how to comply with Bolivian regulatory requirements and commercialize medical devices. Importers of medical devices and pharmaceutical products should review the Bolivian medicines law (Law No. 1737), its implementing regulation (Supreme decree No. 25235 ), and the Bolivian Health Registration Manual.
