Prior approval / evidence record
China NMPA approval: origin evidence only
- Statement
Decreto 3/008 Art. 7 d) requires, for product registration before the Ministry of Public Health, a free-sale certificate issued by the competent body of the country of origin; if the origin authorities do not issue one and MSP deems it pertinent, it may be replaced by a quality certificate from recognized bodies. An NMPA registration/free-sale certificate is therefore the required origin document for China-made devices. The decree contains no reference-country list and no abridged review based on foreign approvals, and MSP evaluates safety and efficacy under Art. 8 f) with the option to require clinical investigation.
- Source Jurisdiction Id
china
- Source Authority Id
nmpa
- Source Approval
China NMPA medical device registration certificate (Class II/III) or Class I filing record
- Target Jurisdiction Id
uruguay
- China Classes In Scope
NMPA Class I filings and Class II/III certificates for all MSP product categories (reactivos de diagnóstico, equipos médicos, dispositivos médicos)
- Edge Type
Origin Country Evidence
- Market Access Strength
Evidence Only
- Regulatory Layer
Product Marketing
- Local Application Required
Yes
- Target Decision Retained
Yes
- CLV from the competent body of the country of origin; substitutable only if that authority does not issue it and MSP agrees
- Art. 8 f): MSP may request clinical investigation if safety/efficacy is not demonstrated
- Registration valid 5 years
- Independent verification is incomplete. Treat this record as a research lead, not a confirmed benefit or exclusion; see the 2026-09-15 independent review.
Effective from 2008-01-17
Source passage: d) certificado de libre venta emitido por el organismo competente del país de origen. En caso de que las autoridades del país de origen no lo emitieran y si el Ministerio de Salud Pública lo juzga pertinente, podrá sustituirse por certificado de calidad otorgado por organismos reconocidos;
