us china canada brazil japan mexico indonesia south korea...
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US
FDA U.S. Food and Drug Administra�on
Local agent
1+ years
I, II and III
Between 10 and 50 thousand euros
Annual device lis�ng and establishment registra�on. Medical Device Single Audit Program (MDSAP).
No expira�on
Authority
Local agent / Authorized representa�ve
Typical �meline,for planning purposes
Device classifica�on
Typical cost (€) of registra�on for CE marked device, for planning purposes
Specific na�onal requirements related to registra�on and quality management system
Device cer�ficate validity
China
NMPANa�onal Medical ProductsAdministra�on
Local agent
1+ years
I, II, III
50 thousand euros or higher
Device type tes�ng and Expert Panel Mee�ngs.
5 years
Canada
Health Canada
Not applicable
1+ years
I, II, III, IV
Between 10 and 50 thousand euros
Medical Device Single Audit Program (MDSAP).Medical Establishment and Medical Device Licenses.
Annual renewal
Brazil
AnvisaBrazilian Health Regulatory Agency
Brazil Registra�on Holder
Less than a year
I, II, III, IV
Between 10 and 50 thousand euros
BGMP requirements.INMETRO Cer�fica�on.Medical Device Single Audit Program (MDSAP).
10 years, no expira�on, depending device classifica�on.
Japan
PMDAPharmaceu�calsand Medical Device Agency
Marke�ng Authoriza�on Holder
1+ years
I, II, III, IV
50 thousand euros or higher
Foreign Manufacturer Registra�on (FMR). Ordinance 169Pre-Market Cer�fica�on. Medical Device Single Audit Program (MDSAP). Quality management system cer�fica�on expires in 5 years.
No expira�on
Mexico
COFEPRISFederal Comission for the Protec�on against Sanitary Risk
Mexico Registra�on Holder
Less than a year
Low risk, I, II, III
Between 10 and 50 thousand euros
Simplified registra�on process for deviceswith prior approvals.
5 years
Indonesia
Badan Pom
Distributor license
Less than a year
I (category A), II (categories B and C),III (category D)
Less than 10 thousand euros
Asean Common Submission Dossier Template (CSDT).
5 years
South Korea
MFDSMinistry of Food and Drug Safety
Korea License Holder
Less than a year
I, II, III, IV
50 thousand euros or higher
Korea Good Manufacturing Prac�ces (KGMP) cer�fica�on. Korea specific product standards.
No expira�on
Australia
TGATherapeu�c Goods Administra�on
Australian sponsor
Less than a year
I, Is and Im, IIa, IIb, III, Ac�ve implantable
Between 10 and 50 thousand euros
Australian Declara�onof Conformity. Medical Device Single Audit Program (MDSAP).
No expira�on
Maleysia
MDA Medical Device Authority of Health Malaysia
Malaysia Authorized Representa�ve
Less than a year
A, B, C, D
Between 10 and 50 thousand euros
Asean Common Submission Dossier Template (CSDT).Labelling requirements for home use devices. Independent Conformity Assessment Body (CAB).
5 years
Saudi Arabia
SFDA Saudi Food and Drug Authority
Saudi authorized representa�ve
Less than a year
Low (class I),medium (class IIa, IIb), high (class III, IV)
Between 10 and 50 thousand euros
English,Arabic labelling requirements. Conformity Assessment Body. Establishment license.
3-5 years
Colombia
INVIMA Na�onal Ins�tute of Food and Drug Monitoring
Colombia Legal Representa�ve
Less than a year
I, IIa, IIb, III
Less than 10 thousand euros
10 years
United Arab Emirates
MOHMinistry of Health
UAE authorized representa�ve
Less than a year
I, IIa, IIb, III
Less than 10 thousand euros
Company registra�on. Simplified registra�on process for devices with prior approvals.
5 years
Singapore
HSA Health Sciences Authority
Local registrant
Less than a year
A, B, C, D
Between 10 and 50 thousand euros
Simplified registra�on process for devices with prior approvals.Asean Common Submission Dossier Template (CSDT).
No expira�on
South Africa
SAHPRA South African Health Products Regulatory Authority
Local Authorized Representa�ve
Less than a year
A, B, C, D
Less than 10thousand euros
Manufacturer, distributor licensing.ISO 13485 cer�fica�on.
5 years
Uzbekistan
MOH Ministry of Health
Local Authorized Representa�ve
Less than a year
I, IIa, IIb, III
Less than 10 thousand euros
Manufacturing site inspec�on. Russian transla�on of manual is needed
5 years
Ukraine
SAUMPState Administra�on of Ukreine on Medicinal Products
Local Authorized Representa�ve
Less than a year
I, IIa, IIb, III
Less than 10 thousand euros
Conformity Assessment Procedure.
5 years
Iran
COMECentral Office for Medical Equipment
Local Authorized Representa�ve
Less than a year
A, B, C, D
Less than 10 thousand euros
Common Submission Dossier Template (CSDT). Site Master File.
4 years
Israel
AMAR Medical Device Division of the Israeli Ministry of Health
Israel Registra�on Holder
Less than a year
No na�onal device classifica�on
Less than 10 thousand euros
Simplified registra�on process for devices with prior approvals. Specific language requirements for professional vs home use. Israel Standard Ins�tute (ISI) valida�on and cer�fica�on.
5 years
Authority
Local agent / Authorized representa�ve
Typical �meline,for planning purposes
Device classifica�on
Typical cost (€) of registra�on for CE marked device, for planning purposes
Specific na�onal requirements related to registra�on and quality management system
Device cer�ficate validity