D01
Authority & regime
No source-verified answer is published for this dimension yet.
0 source-linked facts
Agence du Médicament de Madagascar · Middle East & AfricaMadagascar medical device regulatory resources
Every Madagascar dataset, comparison, and AI workpaper we maintain — one entry point for the whole market.
1 free resources0/25 topics with records5 regulations tracked
Everything we track for Madagascar
Structured regulatory requirements
Explore all 0 source-linked facts →0 of 25 research dimensions currently covered · 0 official sources
Market entry
Unresolved
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D02
Legal basis & guidance
No source-verified answer is published for this dimension yet.
0 source-linked facts
D03
Device definition & scope
No source-verified answer is published for this dimension yet.
0 source-linked facts
D04
Classification rules
No source-verified answer is published for this dimension yet.
0 source-linked facts
D05
Registration pathways
No source-verified answer is published for this dimension yet.
0 source-linked facts
D06
Reliance & recognition
No source-verified answer is published for this dimension yet.
0 source-linked facts
D07
Economic-operator roles
No source-verified answer is published for this dimension yet.
0 source-linked facts
D08
Establishment, import & distribution
No source-verified answer is published for this dimension yet.
0 source-linked facts
D09
Dossier requirements
No source-verified answer is published for this dimension yet.
0 source-linked facts
D10
Official forms & portals
No source-verified answer is published for this dimension yet.
0 source-linked facts
Submission & evidence
D11
Label, IFU & language
No source-verified answer is published for this dimension yet.
0 source-linked facts
D12
QMS, audit & inspection
No source-verified answer is published for this dimension yet.
0 source-linked facts
D13
Standards, testing & ancillary approvals
No source-verified answer is published for this dimension yet.
0 source-linked facts
D14
Fees
No source-verified answer is published for this dimension yet.
0 source-linked facts
D15
Review clocks
No source-verified answer is published for this dimension yet.
0 source-linked facts
D16
Approval validity & renewal
No source-verified answer is published for this dimension yet.
0 source-linked facts
Lifecycle & post-market
D17
Change control
No source-verified answer is published for this dimension yet.
0 source-linked facts
D18
UDI, listing & traceability
No source-verified answer is published for this dimension yet.
0 source-linked facts
D19
Clinical investigation & performance
No source-verified answer is published for this dimension yet.
0 source-linked facts
D20
Special access & derogation
No source-verified answer is published for this dimension yet.
0 source-linked facts
D21
Manufacturer PMS
No source-verified answer is published for this dimension yet.
0 source-linked facts
D22
Vigilance & incident reporting
No source-verified answer is published for this dimension yet.
0 source-linked facts
D23
Recall, FSCA & market surveillance
No source-verified answer is published for this dimension yet.
0 source-linked facts
D24
Advertising, claims & promotion
No source-verified answer is published for this dimension yet.
0 source-linked facts
D25
Submission communications & appeal
No source-verified answer is published for this dimension yet.
0 source-linked facts
Key regulations
All 5 Madagascar regulations →Official Agence du Médicament de Madagascar rules and guidance · 5 of 5 documents linked to official sources
Décision n° 3604/2022-MSANP du 4 juillet 2022Relative à l’autorisation d’importation, de vente et d’utilisation des tests de diagnostic de la Covid-19 à Madagascar
RegistrationVerifiedArrêté n° 7856/2001 du 2 juillet 2001Importation et vente des dispositifs médicaux
RegistrationVerifiedLoi n° 2011-002Code de la Santé — dispositions relatives aux dispositifs médicaux et aux lentilles de contact
GeneralVerifiedArrêté n° 25941/2014-MSANP du 22 septembre 2014Réglementant la vente et l’utilisation des Tests de Diagnostic Rapide pour le traitement du paludisme à Madagascar
RegistrationVerifiedContinue with this market
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