Prior approval / evidence record
IVD simplified registration (PSR) for products authorised by PAHO/WHO, IMDRF or bilateral-partner authorities
- Statement
Class II, III and IV in-vitro diagnostic products already authorised and commercialised in countries regulated by PAHO/WHO reference regulatory authorities, by authorities of IMDRF Management Committee member countries, or by authorities with bilateral agreements with DINAVISA enter the Proceso Simplificado de Registro Sanitario (PSR). DINAVISA has 15 business days to validate and decide, and approval follows by positive silence if no report is issued.
- Source Approval
PAHO/WHO reference regulatory authorities; authorities of IMDRF Management Committee member countries (the IMDRF committee includes US FDA, EU, Japan PMDA/MHLW, Health Canada, TGA, ANVISA, China NMPA, Korea MFDS, Singapore HSA and UK MHRA); authorities with bilateral agreements with DINAVISA
- Edge Type
Abridged Or Recognition Route
- Market Access Strength
facilitated
- Regulatory Layer
Premarket Review
- Local Application Required
Yes
- Target Decision Retained
Yes
- Applies to class II, III and IV IVDs (Res. 44/2024 Art. 7: 'Clases II, III y IV'); class I IVDs are registered automatically under Res. 266/2022 Art. 14.
- The IVD must actually be commercialised in one of those countries and the foreign registration must correspond specifically to the same product being registered.
- 15 business days to validate; approval by positive silence.
- Objections may be answered only once (Art. 3), with 30 business days to rectify.
- Not applicable to the cases in Arts. 13 and 16 of Res. DINAVISA N° 266/2022 (Art. 11).
Effective from 2024-01-30
Source language: Spanish. Translation of the operative part of Art. 2: 'Applications for sanitary registration of In Vitro Diagnostic Products ... that are authorised and commercialised in countries regulated by: PAHO/WHO Reference Regulatory Authorities; Regulatory Authorities of member countries of the Committee of the International Medical Device Regulators Forum - IMDRF; Regulatory Authorities with which bilateral agreements with DINAVISA exist, shall be subject to the Simplified Sanitary Registration Process (PSR).' and 'DINAVISA shall have a term of 15 (fifteen) business days to validate the required documentation and decide thereon. Once the term has elapsed with no report from DINAVISA, the application shall be approved.' Article numbering confirmed by reading the page image of the official PDF.
