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NMPA SAMR

SAMR Decree No. 47

Provisions for Medical Device Registration and Filing
ChinaNational Medical Products AdministrationRegistrationEffective October 1, 2021
Official source linked
What this code is

SAMR Decree No. 47 is the official NMPA identifier for “Provisions for Medical Device Registration and Filing”. SAMR Decree No. 47 is the official identifier NMPA uses for this instrument.

Instrument
SAMR
Full name
SAMR Decree No. 47
Category
Registration
Source links
Authority source
English
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Issuing-authority publication; confirm whether a later amendment or consolidated version applies.
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124 articles · 1 language version
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Dates
Published
August 26, 2021
Effective
October 1, 2021
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Each version has stable article anchors for direct citations and highlighting. The readable text is generated from an authority source and does not replace the legally controlling publication.

English full text124 articles · English — authority translationRead HTML →
About this regulation

Provisions for Medical Device Registration and Filing

SAMR Decree No. 47 as published in NMPA English. Authority English is a translation; the Chinese expression controls. Articles 1–124 are ingested from the official HTML page. Covers Class I filing, Class II/III registration, and technical documentation requirements.

SAMR Decree No. 47 is the official identifier NMPA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.

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