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Ministère de la Santé et de la Population · Middle East & Africa

Republic of the Congo medical device regulatory resources

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1 free resources0/25 topics with records24 regulations tracked
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Medical device regulations

Original national legal texts and authority guidance relevant to medical devices, with source and page references.

Structured regulatory requirements

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0 of 25 research dimensions currently covered · 0 official sources

Market entry

D01

Authority & regime

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D02

Legal basis & guidance

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D03

Device definition & scope

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D04

Classification rules

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D05

Registration pathways

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D06

Reliance & recognition

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D07

Economic-operator roles

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D08

Establishment, import & distribution

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D09

Dossier requirements

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D10

Official forms & portals

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Submission & evidence

D11

Label, IFU & language

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D12

QMS, audit & inspection

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D13

Standards, testing & ancillary approvals

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D14

Fees

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D15

Review clocks

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D16

Approval validity & renewal

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Lifecycle & post-market

D17

Change control

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D18

UDI, listing & traceability

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D19

Clinical investigation & performance

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D20

Special access & derogation

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D21

Manufacturer PMS

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D22

Vigilance & incident reporting

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D23

Recall, FSCA & market surveillance

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D24

Advertising, claims & promotion

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D25

Submission communications & appeal

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Key regulations

All 24 Republic of the Congo regulations →

Official Ministère de la Santé et de la Population rules and guidance · 24 of 24 documents linked to official sources

Loi n° 19-2015 du 29 octobre 2015Création de l’agence congolaise de normalisation et de la qualité
GeneralVerified
Décret n° 2023-159 du 10 mai 2023Approbation des statuts modifiés de l’agence congolaise de normalisation et de la qualité, avec les statuts annexés
GeneralVerified
Loi n° 26-2015 du 29 octobre 2015Création de la centrale d’achat des médicaments essentiels et des produits de santé
GeneralVerified
Décret n° 2017-268 du 28 juillet 2017Approbation des statuts de la centrale d’achat des médicaments essentiels et des produits de santé
GeneralVerified
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Compare an existing authorization and evidence set against Ministère de la Santé et de la Population administrative, testing, labeling, and dossier needs.

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Republic of the Congo cybersecurity evidence review

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