Regulatory reference
China NMPA approval: not reference
- Statement
Registration with ALIMS under the Pravilnik o registraciji medicinskog sredstva (Sl. glasnik RS 84/2018, 58/2021, 6/2023) requires a Declaration of Conformity and, for all devices other than Class I and 'other' IVDs, an EC Certificate issued by a notified body; for Class I/other-IVD manufacturers from states that are not EU members and have no MRA/PECA with the EU, an accredited ISO 13485 certificate or proof that the device is marketed in an EU/MRA state is required. The bylaw's recognition procedure (Član 3-5) tests whether the foreign technical regulation and conformity-assessment body give at least the same protection as the Serbian technical regulation; it names no countries and provides no role for an NMPA registration certificate, so Chinese devices are registered on the basis of CE documentation.
- 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
serbia
- China Classes In Scope
NMPA Class II/III certificates and Class I filings; target all Serbian classes (I, IIa, IIb, III, IVD)
- Edge Type
No Reliance Route
- Market Access Strength
none
- Regulatory Layer
Product Marketing
- Local Application Required
Yes
- Target Decision Retained
Yes
- EC Certificate required except Class I and other IVDs (Član 10, tačka 2).
- Non-EU/non-MRA Class I and other-IVD manufacturers: accredited ISO 13485 certificate or proof of marketing in the EU/MRA states (Član 10, tačka 3).
- Recognition of a foreign document is a separate procedure at the manufacturer's request, decided by equivalence assessment (Član 3-5).
- 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 2023-01-27
Source passage: 2) Сертификат о усаглашености медицинског средства (ЕC Certificate, односно сертификат који издаје именовано тело), осим за медицинска средства класе I и за остала in vitro дијагностичка медицинска средства [...] 3) ако је произвођач медицинских средстава класе I и остала in vitro дијагностичка медицинска средства [...] из државе која није држава чланица ЕУ, односно која није закључила Споразум о међусобном признавању са EУ (Mutual Recognition Agreements – MRAs) [...] сертификат система управљања квалитетом према ISO 13485 [...] односно доказ да се медицинско средство налази у промету у некој од држава чланица ЕУ, односно држава које су закључиле наведене споразуме
