Global Medical Device Registration — Timeline & Fees Report

Regulatory Intelligence Report

Global Medical Device Registration

Timeline & Fees Report

Medical Devices Only · June 2026

75

Countries

4

Regions

3

Table Types

2026

Data Year

This report covers medical devices only. IVD (In Vitro Diagnostic) data has been intentionally excluded and will be published in a separate report. Data is sourced from official regulatory authority publications and the RegDesk regulatory intelligence database.

Medical Devices Only · IVD Excluded

About This Report

This report consolidates regulatory timeline and fee data for medical device registration across 75 countries in four regions: Americas, Europe, Asia-Pacific, and Middle East & Africa. It is designed to support regulatory affairs professionals in budgeting, market prioritization, and submission planning.

Scope: Medical devices only. IVD (In Vitro Diagnostic) data is intentionally excluded. Where a country's official source combines MD and IVD fees, only MD rows are shown.

Data sources: Official regulatory authority publications, government fee schedules (2024–2026), and the RegDesk Regulatory Intelligence Database. Fees shown in local currency unless otherwise noted.

How to use this report: Each region section contains three tables — (1) Registration Timelines by device class, (2) Registration Fees by device class, and (3) Establishment & GMP License Fees. Where official data is not publicly available, cells show "Contact authority." All data should be verified with the relevant authority before submission.

Key Observations

🌎 Americas

Brazil (ANVISA) and Mexico (COFEPRIS) are the most complex markets with mandatory GMP inspections. USA FDA 510(k) pathway takes ~90 days. Canada and Argentina accept MDSAP certification.

🌍 Europe

EU MDR 2017/745 governs all EU/EEA member states. Notified Body bottleneck is a key timeline risk. UK (post-Brexit) requires UKCA marking; MHRA fee: £500 + Notified Body fees.

🌏 Asia-Pacific

Japan (PMDA) Class III/IV can take 12–36 months. China (NMPA) requires local clinical trials for novel Class III devices. New Zealand has no government fees. Singapore Class A devices are exempt.

🌍 Middle East & Africa

Saudi Arabia (SFDA) and UAE (MOHAP) lead in regulatory sophistication. Kenya (PPB) and Botswana (BOMRA) have WHO CRP pathways. Bahrain and Oman have streamlined fee structures.

How to Read the Tables

Table 1 — Registration Timelines: Shows official review/approval timelines per device class (I–IV). Where a country uses different nomenclature (e.g., Low/Medium/High Risk, or A/B/C/D), the closest equivalent class is shown.
Table 2 — Registration Fees: Shows official application/registration fees in local currency. "Contact authority" means fees are not publicly listed — contact the regulatory body directly.
Table 3 — Establishment & GMP Fees: Shows establishment license or GMP inspection fees where available. These are separate from product registration fees.
Special Considerations: Highlights unique country-specific requirements such as reliance pathways, mandatory local agents, MDSAP acceptance, or fee calculation methods.

🌎

Americas

19 countries covered

United States

Canada

Brazil

Mexico

Argentina

Colombia

Chile

Peru

Ecuador

Venezuela

Paraguay

Uruguay

Costa Rica

Panama

El Salvador

Guatemala

Nicaragua

Cuba

Jamaica

RegDesk Regulatory Intelligence · Medical Devices Only

Page 3

🌎 Americas: Registration Timelines (Medical Devices Only)

⬛ Table 1 · Registration review/approval timelines by device risk class

Country	Authority	Class I	Class II	Class III	Class IV	Special Considerations
United States	FDA	510(k): 90d; PMA: 180d	510(k): 90d	PMA: 180d	—	MDSAP accepted. De Novo pathway for novel low-risk devices.
Canada	Health Canada	30d	75d	300d	300d	MDSAP mandatory for Class II–IV. Reliance on FDA/EU decisions available.
Brazil	ANVISA	60d	60d	365d	365d	MDSAP accepted, reduces GMP timeline to 180d. Foreign manufacturer GMP fee fixed at BRL 72,805.
Mexico	COFEPRIS	30d	35d	60d	—	Registration of IVDs combined with MDs. Foreign GMP audit mandatory.
Argentina	ANMAT	60d	90d	180d	—	MERCOSUR mutual recognition applicable.
Colombia	INVIMA	1 month	1 month	4–6 months	4–6 months	MD Classes I/IIa vs IIb/III. INVIMA e-submission platform.
Chile	ISP	60d	60d	60d	—	ISP updates fees annually. Conformity verification: CLP 3,368,543.
Peru	DIGEMID	7d	30d	90d	—	—
Ecuador	ARCSA	30d	60d	90d	—	—
Venezuela	INHRR	60d	90d	180d	—	Import license required per shipment.
Paraguay	DINAVISA	30d	60d	90d	—	MERCOSUR member; mutual recognition pathway available.
Uruguay	MSP	30d	60d	90d	—	MERCOSUR member.
Costa Rica	MINSA/MS	30d	60d	90d	—	—
Panama	MINSA	30d	60d	90d	—	—
El Salvador	MINSAL	30d	60d	90d	—	—
Guatemala	MSPAS	30d	60d	90d	—	—
Nicaragua	MINSA	30d	60d	90d	—	—
Cuba	CECMED	60d	90d	180d	—	Import restrictions; liaison agent required.

Note: WD = Working Days. Timelines are official targets or estimates. Clock starts upon acceptance of a complete dossier. IVD timelines excluded.

🌎 Americas: Registration Timelines (Medical Devices Only)

⬛ Table 1 · Registration review/approval timelines by device risk class

Country	Authority	Class I	Class II	Class III	Class IV	Special Considerations
Jamaica	MOH Jamaica	Contact MOH	Contact MOH	Contact MOH	—	—

Note: WD = Working Days. Timelines are official targets or estimates. Clock starts upon acceptance of a complete dossier. IVD timelines excluded.

🌎 Americas: Registration Fees (Medical Devices Only)

⬛ Table 2 · Official application and registration fees in local currency

Country	Authority	Class I/II Fee	Class III/IV Fee	Renewal Fee	Special Considerations
United States	FDA	510(k): $19,870 / 510(k): $19,870	PMA: $441,547	Annual estab. reg.	MDSAP accepted. De Novo pathway for novel low-risk devices.
Canada	Health Canada	C$330 / C$4,905	C$15,695	5 years	MDSAP mandatory for Class II–IV. Reliance on FDA/EU decisions available.
Brazil	ANVISA	BRL 1,952 (small) / BRL 1,952 (small)	BRL 8,500+	10 years	MDSAP accepted, reduces GMP timeline to 180d. Foreign manufacturer GMP fee fixed at BRL 72,805.
Mexico	COFEPRIS	MXN 15,896 / MXN 23,314	MXN 29,673	MXN 11,922–22,255	Registration of IVDs combined with MDs. Foreign GMP audit mandatory.
Argentina	ANMAT	Contact ANMAT / Contact ANMAT	Contact ANMAT	5 years	MERCOSUR mutual recognition applicable.
Colombia	INVIMA	COP 3,898,330 / COP 3,898,330	COP 4,412,400	10 years	MD Classes I/IIa vs IIb/III. INVIMA e-submission platform.
Chile	ISP	CLP 190,432 / CLP 190,432	CLP 190,432	Per ISP schedule	ISP updates fees annually. Conformity verification: CLP 3,368,543.
Peru	DIGEMID	Contact DIGEMID / Contact DIGEMID	Contact DIGEMID	5 years	—
Ecuador	ARCSA	Contact ARCSA / Contact ARCSA	Contact ARCSA	5 years	—
Venezuela	INHRR	Contact INHRR / Contact INHRR	Contact INHRR	5 years	Import license required per shipment.
Paraguay	DINAVISA	Contact DINAVISA / Contact DINAVISA	Contact DINAVISA	5 years	MERCOSUR member; mutual recognition pathway available.
Uruguay	MSP	Contact MSP / Contact MSP	Contact MSP	5 years	MERCOSUR member.
Costa Rica	MINSA/MS	Contact MINSA / Contact MINSA	Contact MINSA	5 years	—
Panama	MINSA	Contact MINSA / Contact MINSA	Contact MINSA	5 years	—
El Salvador	MINSAL	Contact MINSAL / Contact MINSAL	Contact MINSAL	5 years	—
Guatemala	MSPAS	Contact MSPAS / Contact MSPAS	Contact MSPAS	5 years	—
Nicaragua	MINSA	Contact MINSA / Contact MINSA	Contact MINSA	5 years	—
Cuba	CECMED	Contact CECMED / Contact CECMED	Contact CECMED	5 years	Import restrictions; liaison agent required.

Note: Fees shown in local currency unless stated. 'Contact authority' = fees not publicly listed. IVD fees excluded. EU MDR states: Notified Body fees are privately contracted and vary widely.

🌎 Americas: Registration Fees (Medical Devices Only)

⬛ Table 2 · Official application and registration fees in local currency

Country	Authority	Class I/II Fee	Class III/IV Fee	Renewal Fee	Special Considerations
Jamaica	MOH Jamaica	Contact MOH / Contact MOH	Contact MOH	Not published	—

Note: Fees shown in local currency unless stated. 'Contact authority' = fees not publicly listed. IVD fees excluded. EU MDR states: Notified Body fees are privately contracted and vary widely.

🌎 Americas: Establishment & GMP License Fees

⬛ Table 3 · Establishment license, manufacturer license, and GMP inspection fees

Country	Authority	Establishment / GMP License Fee
United States	FDA	$9,280/yr
Canada	Health Canada	—
Brazil	ANVISA	AFE: BRL 1,952–19,524; GMP: BRL 2,659–72,805
Mexico	COFEPRIS	Foreign GMP: MXN 126,070
Argentina	ANMAT	Contact ANMAT
Colombia	INVIMA	GMP cert: COP 2,569,000+
Chile	ISP	Warehouse: CLP 1,048,089
Peru	DIGEMID	Contact authority
Ecuador	ARCSA	Contact authority
Venezuela	INHRR	Contact authority
Paraguay	DINAVISA	Contact authority
Uruguay	MSP	Contact authority
Costa Rica	MINSA/MS	Contact authority
Panama	MINSA	Contact authority
El Salvador	MINSAL	Contact authority
Guatemala	MSPAS	Contact authority
Nicaragua	MINSA	Contact authority
Cuba	CECMED	Contact authority
Jamaica	MOH Jamaica	Contact authority

Note: Establishment fees are separate from product registration fees. 'Contact authority' = fees not publicly listed.

🌍

Europe

19 countries covered

United Kingdom

France

Spain

Sweden

Switzerland

Austria

Belgium

Finland

Portugal

Greece

Romania

Slovakia

Estonia

Latvia

Serbia

Bosnia and Herzegovina

Albania

Malta

Russian Federation

RegDesk Regulatory Intelligence · Medical Devices Only

Page 9

🌍 Europe: Registration Timelines (Medical Devices Only)

⬛ Table 1 · Registration review/approval timelines by device risk class

Country	Authority	Class I	Class II	Class III	Class IV	Special Considerations
United Kingdom	MHRA	No premarket review	Notified Body review (varies)	Notified Body review (varies)	—	Post-Brexit UKCA marking required. EU MDR CE no longer accepted from Jul 2025.
France	ANSM	Self-declaration	Notified Body review	Notified Body review	—	EU MDR 2017/745 applies. EUDAMED database registration mandatory.
Spain	AEMPS	Self-declaration	Notified Body review	Notified Body review	—	EU MDR applies. Spanish national registry required.
Sweden	MPA	Self-declaration	Notified Body review	Notified Body review	—	EU MDR applies. Clinical trial fee charged by MPA.
Switzerland	Swissmedic	CHRN registration	Notified Body review	Notified Body review	—	Swiss MedDO (TDG) aligned with EU MDR. Economic operators must register within 3 months.
Austria	BASG	Self-declaration	Notified Body review	Notified Body review	—	EU MDR applies. Small-company exemption if annual fee >1% of MD turnover.
Belgium	FAMHP	Self-declaration	Notified Body review	Notified Body review	—	EU MDR applies. Clinical trial (Class I–II): €12,847.
Finland	Fimea	Self-declaration	Notified Body review	Notified Body review	—	EU MDR applies. Inspection fee for authorized rep / importers.
Portugal	INFARMED	Self-declaration	Notified Body review	Notified Body review	—	EU MDR applies. Fee is 0.4% of monthly sales, paid via SRCT Portal.
Greece	EOF	Self-declaration	Notified Body review	Notified Body review	—	EU MDR applies. Class I registration fee tiered by product count.
Romania	ANMDMR	Self-declaration	Notified Body review	Notified Body review	—	EU MDR applies. Free-sale certificate: RON 1,446 (1–10 items).
Slovakia	ŠÚKL	Self-declaration (free)	Notified Body review	Notified Body review	—	EU MDR applies. Notification is cost-free; tech-doc assessment €845.
Estonia	SAM	Self-declaration	Notified Body review	Notified Body review	—	EU MDR applies. Paid services per SAM decree.
Latvia	ZVA	Self-declaration	Notified Body review	Notified Body review	—	EU MDR applies. Annual vigilance fee per manufacturer/AR/distributor.
Serbia	ALIMS	CE mark reliance	CE mark reliance	CE mark reliance	—	Fee tiered by product count (up to 25 / 26–100 / 100+).
Bosnia and Herzegovina	ALMBiH	CE mark reliance	CE mark reliance	CE mark reliance	—	CE marking accepted; national registration required.
Albania	AKBPM	CE mark required	CE mark required	CE mark required	—	CE marking accepted for market access.
Malta	MCCAA	Self-declaration	Notified Body review	Notified Body review	—	EU MDR applies. Notification fee €15 per device per year.

Note: WD = Working Days. Timelines are official targets or estimates. Clock starts upon acceptance of a complete dossier. IVD timelines excluded.

🌍 Europe: Registration Timelines (Medical Devices Only)

⬛ Table 1 · Registration review/approval timelines by device risk class

Country	Authority	Class I	Class II	Class III	Class IV	Special Considerations
Russian Federation	Roszdravnadzor	75d	75d	75d	—	State registration required. Foreign manufacturer must have authorized rep.

Note: WD = Working Days. Timelines are official targets or estimates. Clock starts upon acceptance of a complete dossier. IVD timelines excluded.

🌍 Europe: Registration Fees (Medical Devices Only)

⬛ Table 2 · Official application and registration fees in local currency

Country	Authority	Class I/II Fee	Class III/IV Fee	Renewal Fee	Special Considerations
United Kingdom	MHRA	MHRA reg: £500 / Notified Body fee (varies)	Notified Body fee (varies)	Annual MHRA reg.	Post-Brexit UKCA marking required. EU MDR CE no longer accepted from Jul 2025.
France	ANSM	Not specified by ANSM / Notified Body fee	Notified Body fee	EUDAMED registration	EU MDR 2017/745 applies. EUDAMED database registration mandatory.
Spain	AEMPS	€99.71 (listing) / €491.92 (import lic)	Notified Body fee	EUDAMED + AEMPS	EU MDR applies. Spanish national registry required.
Sweden	MPA	Not specified / Notified Body fee	Notified Body fee	EUDAMED	EU MDR applies. Clinical trial fee charged by MPA.
Switzerland	Swissmedic	Swissmedic fee / Notified Body fee	Notified Body fee	Annual CHRN update	Swiss MedDO (TDG) aligned with EU MDR. Economic operators must register within 3 months.
Austria	BASG	Annual BASG fee / Notified Body fee	Notified Body fee	Annual fee (turnover-based)	EU MDR applies. Small-company exemption if annual fee >1% of MD turnover.
Belgium	FAMHP	Contact FAMHP / Notified Body fee	Notified Body fee	EUDAMED	EU MDR applies. Clinical trial (Class I–II): €12,847.
Finland	Fimea	Contact Fimea / Notified Body fee	Notified Body fee	EUDAMED	EU MDR applies. Inspection fee for authorized rep / importers.
Portugal	INFARMED	0.4% of sales (monthly) / 0.4% of sales	0.4% of sales	EUDAMED + INFARMED	EU MDR applies. Fee is 0.4% of monthly sales, paid via SRCT Portal.
Greece	EOF	€200–1,000 (1–50+ products) / Notified Body fee	Notified Body fee	EUDAMED + EOF	EU MDR applies. Class I registration fee tiered by product count.
Romania	ANMDMR	RON 139 (customs decl.) / Notified Body fee	Notified Body fee	EUDAMED + ANMDMR	EU MDR applies. Free-sale certificate: RON 1,446 (1–10 items).
Slovakia	ŠÚKL	Free / €845 (first notification)	€845 (first notification)	EUDAMED	EU MDR applies. Notification is cost-free; tech-doc assessment €845.
Estonia	SAM	Contact SAM / Notified Body fee	Notified Body fee	EUDAMED	EU MDR applies. Paid services per SAM decree.
Latvia	ZVA	Annual vigilance: €105 / Annual vigilance: €202	Annual vigilance: €202	EUDAMED	EU MDR applies. Annual vigilance fee per manufacturer/AR/distributor.
Serbia	ALIMS	RSD 8,100–13,450 / RSD 20,200–33,600	RSD 26,600–40,400	Per ALIMS schedule	Fee tiered by product count (up to 25 / 26–100 / 100+).
Bosnia and Herzegovina	ALMBiH	BAM 200 (≤25 products) / BAM 400 (≤25 products)	BAM 400+	Per ALMBiH schedule	CE marking accepted; national registration required.
Albania	AKBPM	Contact AKBPM / Contact AKBPM	Contact AKBPM	Not published	CE marking accepted for market access.
Malta	MCCAA	€15/device (notif.) / Notified Body fee	Notified Body fee	Annual (€15/device)	EU MDR applies. Notification fee €15 per device per year.

Note: Fees shown in local currency unless stated. 'Contact authority' = fees not publicly listed. IVD fees excluded. EU MDR states: Notified Body fees are privately contracted and vary widely.

🌍 Europe: Registration Fees (Medical Devices Only)

⬛ Table 2 · Official application and registration fees in local currency

Country	Authority	Class I/II Fee	Class III/IV Fee	Renewal Fee	Special Considerations
Russian Federation	Roszdravnadzor	Contact Roszdravnadzor / Contact Roszdravnadzor	Contact Roszdravnadzor	Indefinite (GMP renewal periodic)	State registration required. Foreign manufacturer must have authorized rep.

Note: Fees shown in local currency unless stated. 'Contact authority' = fees not publicly listed. IVD fees excluded. EU MDR states: Notified Body fees are privately contracted and vary widely.

🌍 Europe: Establishment & GMP License Fees

⬛ Table 3 · Establishment license, manufacturer license, and GMP inspection fees

Country	Authority	Establishment / GMP License Fee
United Kingdom	MHRA	Contact Notified Body
France	ANSM	Contact authority
Spain	AEMPS	Mfg license: €983.55
Sweden	MPA	Contact MPA
Switzerland	Swissmedic	CHRN: Swiss representative required
Austria	BASG	Contact BASG
Belgium	FAMHP	Contact FAMHP
Finland	Fimea	Inspection: €2,750/day
Portugal	INFARMED	Contact INFARMED
Greece	EOF	Contact EOF
Romania	ANMDMR	Classification: RON 3,311
Slovakia	ŠÚKL	Contact ŠÚKL
Estonia	SAM	Contact SAM
Latvia	ZVA	Contact ZVA
Serbia	ALIMS	Contact ALIMS
Bosnia and Herzegovina	ALMBiH	Contact ALMBiH
Albania	AKBPM	Contact authority
Malta	MCCAA	Distributor/importer: €500/yr
Russian Federation	Roszdravnadzor	Contact authority

Note: Establishment fees are separate from product registration fees. 'Contact authority' = fees not publicly listed.

🌏

Asia-Pacific

13 countries covered

Japan

China

India

Korea, Republic of

Australia

New Zealand

Singapore

Taiwan

Thailand

Malaysia

Pakistan

Sri Lanka

Cambodia

RegDesk Regulatory Intelligence · Medical Devices Only

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🌏 Asia-Pacific: Registration Timelines (Medical Devices Only)

⬛ Table 1 · Registration review/approval timelines by device risk class

Country	Authority	Class I	Class II	Class III	Class IV	Special Considerations
Japan	PMDA/MHLW	Notification (self-declared)	RCB certification: 3–6 months	PMDA approval: 12–24 months	PMDA approval: 24–36 months	Foreign Manufacturer Registration (FMR) mandatory. MAH (Daihyo) license required.
China	NMPA	1–2 months (filing)	6–9 months	12–18 months	—	Class III requires local clinical trials for novel devices. NMPA reliance pathway expanding.
India	CDSCO	30d (import license)	30–90d	90–180d	—	Overseas site inspection fee: USD 3,000 per site. MD Notification required before import.
Korea, Republic of	MFDS	Notification: 30d	Approval: 180d	Approval: 180d	Approval: 180d	QMS audit by MFDS or notified body required. PMS plan mandatory.
Australia	TGA	ARTG listing: 1–5d	ARTG registration: 3–12 months	ARTG registration: 3–12 months	ARTG registration: 12–24 months	MDSAP accepted. TGA uses risk-based pathway; conformity assessment certificate required for Class III/IV.
New Zealand	Medsafe	WAND: 1–3d	WAND: 1–3d	WAND: 1–3d	—	Notification-based system (WAND database). No pre-market approval or govt fees. CE/TGA/FDA reference accepted.
Singapore	HSA	Exempt (Class A)	30–90d	90–270d	—	Class A devices exempt from registration. HSA accepts ASEAN CSDT dossier format.
Taiwan	TFDA	80d	80d	120d	—	Local clinical study may be required for Class III. Local Taiwanese agent mandatory.
Thailand	FDA Thailand	30d	90d	180d	—	Import license and sale license required separately. Sale license: THB 10,000.
Malaysia	MDA	Registration required	Registration required	Registration required	—	Medical Device Act 2012 applies. Local authorized representative required.
Pakistan	DRAP	1d (Class A enlistment)	30d (Class B enlistment)	90d+	—	Establishment license renewal: PKR 12,500. Change in particulars: 50% of license fee.
Sri Lanka	NMRA	Prelim eval: 12 months	Prelim eval: 12 months	Product reg: 1–5 years	—	Two-step process: Preliminary Evaluation then Product Registration. Local agent mandatory.
Cambodia	DDF	Not specified	Not specified	Not specified	—	Flat registration fee across all classes.

Note: WD = Working Days. Timelines are official targets or estimates. Clock starts upon acceptance of a complete dossier. IVD timelines excluded.

🌏 Asia-Pacific: Registration Fees (Medical Devices Only)

⬛ Table 2 · Official application and registration fees in local currency

Country	Authority	Class I/II Fee	Class III/IV Fee	Renewal Fee	Special Considerations
Japan	PMDA/MHLW	~USD 100–200 / ~USD 3,000–6,000	~USD 10,000–30,000	Every 5 years (~USD 3,000–10,000)	Foreign Manufacturer Registration (FMR) mandatory. MAH (Daihyo) license required.
China	NMPA	Contact NMPA / Contact NMPA	Contact NMPA	5 years	Class III requires local clinical trials for novel devices. NMPA reliance pathway expanding.
India	CDSCO	USD 1,000 (import) / USD 2,000	USD 3,000	Annual retention: USD 500/device	Overseas site inspection fee: USD 3,000 per site. MD Notification required before import.
Korea, Republic of	MFDS	KRW 5,000 (import clearance) / Notified Body fee (variable)	Notified Body fee (variable)	180d process; fee TBD	QMS audit by MFDS or notified body required. PMS plan mandatory.
Australia	TGA	AUD 180–910 (listing) / AUD 270–3,980	AUD 270–3,980	Annual ARTG charge	MDSAP accepted. TGA uses risk-based pathway; conformity assessment certificate required for Class III/IV.
New Zealand	Medsafe	No govt fee / No govt fee	No govt fee	No formal renewal	Notification-based system (WAND database). No pre-market approval or govt fees. CE/TGA/FDA reference accepted.
Singapore	HSA	Exempt / SGD 340–680	SGD 1,140–2,280	5 years	Class A devices exempt from registration. HSA accepts ASEAN CSDT dossier format.
Taiwan	TFDA	TWD 15,000 / TWD 58,000	TWD 100,000	Per TFDA schedule	Local clinical study may be required for Class III. Local Taiwanese agent mandatory.
Thailand	FDA Thailand	THB 100,000 (mfg license) / THB 200,000 (import license)	THB 200,000+	Per FDA Thailand schedule	Import license and sale license required separately. Sale license: THB 10,000.
Malaysia	MDA	Contact MDA / Contact MDA	Contact MDA	5 years	Medical Device Act 2012 applies. Local authorized representative required.
Pakistan	DRAP	PKR 6,300 / PKR 6,300	Contact DRAP	PKR 3,150/yr	Establishment license renewal: PKR 12,500. Change in particulars: 50% of license fee.
Sri Lanka	NMRA	Contact NMRA / Contact NMRA	Contact NMRA	1, 2, or 5 years	Two-step process: Preliminary Evaluation then Product Registration. Local agent mandatory.
Cambodia	DDF	USD 98 / USD 98	USD 98	Contact DDF	Flat registration fee across all classes.

Note: Fees shown in local currency unless stated. 'Contact authority' = fees not publicly listed. IVD fees excluded. EU MDR states: Notified Body fees are privately contracted and vary widely.

🌏 Asia-Pacific: Establishment & GMP License Fees

⬛ Table 3 · Establishment license, manufacturer license, and GMP inspection fees

Country	Authority	Establishment / GMP License Fee
Japan	PMDA/MHLW	FMR: ~USD 1,000–1,500; QMS: ~USD 6,000–10,000
China	NMPA	Local agent (SR) required; GMP inspection mandatory
India	CDSCO	Import license: USD 3,000 (one site)
Korea, Republic of	MFDS	MFDS manufacturing license
Australia	TGA	AUD 583 (non-compliance consent)
New Zealand	Medsafe	No govt fee
Singapore	HSA	HSA product registration only
Taiwan	TFDA	Contact TFDA
Thailand	FDA Thailand	Mfg establishment: THB 100,000; Import: THB 20,000
Malaysia	MDA	MDA product listing
Pakistan	DRAP	Establishment license: PKR 26,100
Sri Lanka	NMRA	Local agent required
Cambodia	DDF	Contact authority

Note: Establishment fees are separate from product registration fees. 'Contact authority' = fees not publicly listed.

🌍

Middle East & Africa

24 countries covered

Saudi Arabia

United Arab Emirates

Egypt

Oman

Qatar

Bahrain

Jordan

Israel

Lebanon

Yemen

Syrian Arab Republic

Palestine, State of

South Africa

Nigeria

Kenya

Ethiopia

Tanzania

Botswana

Rwanda

Sudan

Algeria

Azerbaijan

Georgia

Mauritius

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Page 19

🌍 Middle East & Africa: Registration Timelines (Medical Devices Only)

⬛ Table 1 · Registration review/approval timelines by device risk class

Country	Authority	Class I	Class II	Class III	Class IV	Special Considerations
Saudi Arabia	SFDA	30d	60d	90d	—	SFDA accepts reliance from US FDA, EU MDR, Health Canada, TGA, PMDA.
United Arab Emirates	MOHAP	10d (classification)	45d	45d	—	Pre-import permit: 3 WD; shipment clearance: 1% CIF. Certificate amendment: AED 1,000.
Egypt	EDA	Normal track	Normal track	Normal track	—	Fast track: EGP 20,000 registration + EGP 13,000 eval. E-services portal available.
Oman	MOH	Exempt (Class A/B)	Exempt (Class A/B)	30d (Class C)	30d (Class D)	Only Class C and D require registration. Class A/B: notification only.
Qatar	MOH Qatar	Contact MOH	Contact MOH	Contact MOH	—	Type approval for wireless-enabled devices: QAR 500–1,000.
Bahrain	NHRA	10–20 WD	10–20 WD	10–20 WD	—	AR licensing required by device class (A–D). Warehouse registration: BHD 1,000.
Jordan	JFDA	10 months (file review)	10 months	10 months	—	License issuance: 45 WD after file review. Import batch clearance: JOD 125.
Israel	AMAR	Contact AMAR	Contact AMAR	Contact AMAR	—	Israel aligns with EU MDR and US FDA recognition.
Lebanon	MOH	Contact MOH	Contact MOH	Contact MOH	—	—
Yemen	SBDMA	60d (prelim approval)	60d	120d (with analysis)	—	Factory inspection: USD 6,000. Importer registration: USD 1,500.
Syrian Arab Republic	MOH Syria	Not published	Not published	Not published	—	Import permit: SP 1,500. Modification fees: 30% of registration fee.
Palestine, State of	MOH Palestine	Contact MOH	Contact MOH	Contact MOH	—	—
South Africa	SAHPRA	Contact SAHPRA	Contact SAHPRA	Contact SAHPRA	—	SAHPRA aligning with PIC/S GMP. MDSAP under consideration.
Nigeria	NAFDAC	120 WD	120 WD	120 WD	—	All fees attract 5% VAT. Registration valid 5 years. Diapers/sanitary pads: USD 874.
Kenya	PPB	Class A: 22 months	Class B: 14–60 WD (reliance) / 22 months	Class C: 90d (reliance) / full eval	Class D: 90d (reliance) / full eval	Reliance pathways available (FDA, EU MDR, TGA, Health Canada, PMDA, etc.). Import permit: 0.75% FOB.
Ethiopia	EFDA	Contact EFDA	Contact EFDA	Contact EFDA	—	EFDA established 2021, replacing FMHACA.
Tanzania	TMDA	Contact TMDA	Contact TMDA	Contact TMDA	—	—
Botswana	BOMRA	3 months (screening)	4–8 months (abridged/full)	6–10 months	8–12 months	WHO CRP pathway: 3 months. Expedited route available at higher fee. Retention: BWP 1,000/group.

Note: WD = Working Days. Timelines are official targets or estimates. Clock starts upon acceptance of a complete dossier. IVD timelines excluded.

🌍 Middle East & Africa: Registration Timelines (Medical Devices Only)

⬛ Table 1 · Registration review/approval timelines by device risk class

Country	Authority	Class I	Class II	Class III	Class IV	Special Considerations
Rwanda	Rwanda FDA	Contact Rwanda FDA	Contact Rwanda FDA	Contact Rwanda FDA	—	—
Sudan	NMPB	Contact NMPB	Contact NMPB	Contact NMPB	—	—
Algeria	ANPP	Contact ANPP	Contact ANPP	Contact ANPP	—	—
Azerbaijan	MHIA	Contact MHIA	Contact MHIA	Contact MHIA	—	—
Georgia	LEPL	Contact LEPL	Contact LEPL	Contact LEPL	—	—
Mauritius	MOH Mauritius	Contact MOH	Contact MOH	Contact MOH	—	—

Note: WD = Working Days. Timelines are official targets or estimates. Clock starts upon acceptance of a complete dossier. IVD timelines excluded.

🌍 Middle East & Africa: Registration Fees (Medical Devices Only)

⬛ Table 2 · Official application and registration fees in local currency

Country	Authority	Class I/II Fee	Class III/IV Fee	Renewal Fee	Special Considerations
Saudi Arabia	SFDA	SAR 1,000 / SAR 2,000	SAR 5,000	5 years	SFDA accepts reliance from US FDA, EU MDR, Health Canada, TGA, PMDA.
United Arab Emirates	MOHAP	AED 5,100 (reg + application) / AED 5,100	AED 5,100	AED 2,600 (renewal)	Pre-import permit: 3 WD; shipment clearance: 1% CIF. Certificate amendment: AED 1,000.
Egypt	EDA	EGP 10,000 (normal) / EGP 10,000 (normal)	EGP 10,000 (normal)	Per EDA schedule	Fast track: EGP 20,000 registration + EGP 13,000 eval. E-services portal available.
Oman	MOH	Exempt / Exempt	OMR 20 (classification)	Contact MOH	Only Class C and D require registration. Class A/B: notification only.
Qatar	MOH Qatar	Contact MOH / Contact MOH	Contact MOH	Contact MOH	Type approval for wireless-enabled devices: QAR 500–1,000.
Bahrain	NHRA	BHD 150 (low risk) / BHD 300 (medium risk)	BHD 1,000 (high risk)	BHD 100–700 (risk-based)	AR licensing required by device class (A–D). Warehouse registration: BHD 1,000.
Jordan	JFDA	JOD 100 / JOD 100	JOD 100	JOD 100	License issuance: 45 WD after file review. Import batch clearance: JOD 125.
Israel	AMAR	Contact AMAR / Contact AMAR	Contact AMAR	Contact AMAR	Israel aligns with EU MDR and US FDA recognition.
Lebanon	MOH	Contact MOH / Contact MOH	Contact MOH	Contact MOH	—
Yemen	SBDMA	USD 100 (prelim reg) / USD 100	USD 200 (with analysis)	USD 50/device	Factory inspection: USD 6,000. Importer registration: USD 1,500.
Syrian Arab Republic	MOH Syria	USD 1,000 / USD 1,200	USD 1,500	USD 500–750	Import permit: SP 1,500. Modification fees: 30% of registration fee.
Palestine, State of	MOH Palestine	Contact MOH / Contact MOH	Contact MOH	Contact MOH	—
South Africa	SAHPRA	Contact SAHPRA / Contact SAHPRA	Contact SAHPRA	Annual retention fee	SAHPRA aligning with PIC/S GMP. MDSAP under consideration.
Nigeria	NAFDAC	USD 750 / USD 750	USD 750	80% of new registration cost	All fees attract 5% VAT. Registration valid 5 years. Diapers/sanitary pads: USD 874.
Kenya	PPB	USD 100 / USD 200	USD 1,000	USD 100–1,000 (class-based)	Reliance pathways available (FDA, EU MDR, TGA, Health Canada, PMDA, etc.). Import permit: 0.75% FOB.
Ethiopia	EFDA	Contact EFDA / Contact EFDA	Contact EFDA	Contact EFDA	EFDA established 2021, replacing FMHACA.
Tanzania	TMDA	Contact TMDA / Contact TMDA	Contact TMDA	Contact TMDA	—
Botswana	BOMRA	BWP 10,000 (listed) / BWP 12,500	BWP 12,500	BWP 5,000	WHO CRP pathway: 3 months. Expedited route available at higher fee. Retention: BWP 1,000/group.

Note: Fees shown in local currency unless stated. 'Contact authority' = fees not publicly listed. IVD fees excluded. EU MDR states: Notified Body fees are privately contracted and vary widely.

🌍 Middle East & Africa: Registration Fees (Medical Devices Only)

⬛ Table 2 · Official application and registration fees in local currency

Country	Authority	Class I/II Fee	Class III/IV Fee	Renewal Fee	Special Considerations
Rwanda	Rwanda FDA	Contact Rwanda FDA / Contact Rwanda FDA	Contact Rwanda FDA	Contact authority	—
Sudan	NMPB	Contact NMPB / Contact NMPB	Contact NMPB	Contact NMPB	—
Algeria	ANPP	Contact ANPP / Contact ANPP	Contact ANPP	Contact ANPP	—
Azerbaijan	MHIA	Contact MHIA / Contact MHIA	Contact MHIA	Contact authority	—
Georgia	LEPL	Contact LEPL / Contact LEPL	Contact LEPL	Contact authority	—
Mauritius	MOH Mauritius	Contact MOH / Contact MOH	Contact MOH	Contact MOH	—

Note: Fees shown in local currency unless stated. 'Contact authority' = fees not publicly listed. IVD fees excluded. EU MDR states: Notified Body fees are privately contracted and vary widely.

🌍 Middle East & Africa: Establishment & GMP License Fees

⬛ Table 3 · Establishment license, manufacturer license, and GMP inspection fees

Country	Authority	Establishment / GMP License Fee
Saudi Arabia	SFDA	SFDA licensed local agent required
United Arab Emirates	MOHAP	Mfg site reg: AED 10,100
Egypt	EDA	Contact EDA
Oman	MOH	No govt fee for establishment approval
Qatar	MOH Qatar	Contact authority
Bahrain	NHRA	AR license: BHD 300–1,000; Warehouse: BHD 1,000
Jordan	JFDA	Contact JFDA
Israel	AMAR	Contact authority
Lebanon	MOH	Contact authority
Yemen	SBDMA	Foreign company: USD 1,000–6,000
Syrian Arab Republic	MOH Syria	Contact MOH Syria
Palestine, State of	MOH Palestine	Contact authority
South Africa	SAHPRA	Establishment licence retention fee (annual)
Nigeria	NAFDAC	Import permit: USD 11,000
Kenya	PPB	Estab. license: KES 45,000 (new); KES 50,000 (renewal)
Ethiopia	EFDA	Contact authority
Tanzania	TMDA	Contact authority
Botswana	BOMRA	Expedited application: BWP 40,000
Rwanda	Rwanda FDA	Contact authority
Sudan	NMPB	Contact authority
Algeria	ANPP	Contact authority
Azerbaijan	MHIA	Contact authority
Georgia	LEPL	Contact authority
Mauritius	MOH Mauritius	Contact authority

Note: Establishment fees are separate from product registration fees. 'Contact authority' = fees not publicly listed.

Data Sources & Regulatory Authority References

Primary sources consulted: Official regulatory authority websites, government gazette publications, and fee schedules as of 2024–2026. All data extracted from publicly available official sources.

Americas

🇺🇸 USA — FDA: fda.gov/medical-devices
🇨🇦 Canada — Health Canada: canada.ca/health
🇧🇷 Brazil — ANVISA: anvisa.gov.br
🇲🇽 Mexico — COFEPRIS: gob.mx/cofepris
🇦🇷 Argentina — ANMAT: anmat.gov.ar
🇨🇴 Colombia — INVIMA: invima.gov.co
🇨🇱 Chile — ISP: ispch.cl
🇵🇪 Peru — DIGEMID: digemid.minsa.gob.pe
🇪🇨 Ecuador — ARCSA: controlsanitario.gob.ec
🇻🇪 Venezuela — INHRR: inhrr.gob.ve
🇵🇾 Paraguay — DINAVISA: mspbs.gov.py
🇺🇾 Uruguay — MSP: msp.gub.uy
🇨🇷 Costa Rica — MINSA: ministeriodesalud.go.cr
🇵🇦 Panama — MINSA: minsa.gob.pa
🇸🇻 El Salvador — MINSAL: salud.gob.sv
🇬🇹 Guatemala — MSPAS: mspas.gob.gt
🇳🇮 Nicaragua — MINSA: minsa.gob.ni
🇨🇺 Cuba — CECMED: cecmed.cu
🇯🇲 Jamaica — MOH: moh.gov.jm

Asia-Pacific

🇯🇵 Japan — PMDA: pmda.go.jp
🇨🇳 China — NMPA: nmpa.gov.cn
🇮🇳 India — CDSCO: cdsco.gov.in
🇰🇷 Korea — MFDS: mfds.go.kr
🇦🇺 Australia — TGA: tga.gov.au
🇳🇿 New Zealand — Medsafe: medsafe.govt.nz
🇸🇬 Singapore — HSA: hsa.gov.sg
🇹🇼 Taiwan — TFDA: fda.gov.tw
🇹🇭 Thailand — FDA Thailand: fda.moph.go.th
🇲🇾 Malaysia — MDA: npra.gov.my
🇵🇰 Pakistan — DRAP: dra.gov.pk
🇱🇰 Sri Lanka — NMRA: nmra.gov.lk
🇰🇭 Cambodia — DDF: maff.gov.kh

Europe

🇬🇧 UK — MHRA: mhra.gov.uk
🇫🇷 France — ANSM: ansm.sante.fr
🇪🇸 Spain — AEMPS: aemps.es
🇸🇪 Sweden — MPA: lakemedelsverket.se
🇨🇭 Switzerland — Swissmedic: swissmedic.ch
🇦🇹 Austria — BASG: basg.gv.at
🇧🇪 Belgium — FAMHP: famhp.be
🇫🇮 Finland — Fimea: fimea.fi
🇵🇹 Portugal — INFARMED: infarmed.pt
🇬🇷 Greece — EOF: eof.gr
🇷🇴 Romania — ANMDMR: anmdmr.ro
🇸🇰 Slovakia — ŠÚKL: sukl.sk
🇪🇪 Estonia — SAM: ravimiamet.ee
🇱🇻 Latvia — ZVA: zva.gov.lv
🇷🇸 Serbia — ALIMS: alims.gov.rs
🇧🇦 Bosnia — ALMBiH: almbih.gov.ba
🇦🇱 Albania — AKBPM: akbpm.gov.al
🇲🇹 Malta — MCCAA: medicines.org.mt
🇷🇺 Russia — Roszdravnadzor: roszdravnadzor.gov.ru

Middle East & Africa

🇸🇦 Saudi Arabia — SFDA: sfda.gov.sa
🇦🇪 UAE — MOHAP: mohap.gov.ae
🇪🇬 Egypt — EDA: edaegypt.gov.eg
🇴🇲 Oman — MOH: moh.gov.om
🇶🇦 Qatar — MOH: moph.gov.qa
🇧🇭 Bahrain — NHRA: nhra.bh
🇯🇴 Jordan — JFDA: jfda.jo
🇮🇱 Israel — AMAR: health.gov.il
🇱🇧 Lebanon — MOH: moph.gov.lb
🇾🇪 Yemen — SBDMA: sbdma.gov.ye
🇸🇾 Syria — MOH: moh.gov.sy
🇵🇸 Palestine — MOH: moh.gov.ps
🇿🇦 South Africa — SAHPRA: sahpra.org.za
🇳🇬 Nigeria — NAFDAC: nafdac.gov.ng
🇰🇪 Kenya — PPB: ppb.go.ke
🇪🇹 Ethiopia — EFDA: efda.gov.et
🇹🇿 Tanzania — TMDA: tmda.go.tz
🇧🇼 Botswana — BOMRA: bomra.co.bw
🇷🇼 Rwanda — Rwanda FDA: rbc.gov.rw
🇸🇩 Sudan — NMPB: nmpb.gov.sd
🇩🇿 Algeria — ANPP: sante.gov.dz
🇦🇿 Azerbaijan — MHIA: e-gov.az
🇬🇪 Georgia — LEPL: moh.gov.ge
🇲🇺 Mauritius — MOH: health.govmu.org

Disclaimer: This report is generated from the RegDesk Regulatory Intelligence Platform. All fees and timelines are subject to change without notice. This document is for informational purposes only and does not constitute legal or regulatory advice. Users must independently verify all information with the relevant regulatory authority before making submission decisions. IVD (In Vitro Diagnostic) data has been intentionally excluded from this report.