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