Global Medical Device Registration — Timeline & Fees Report V2

Regulatory Intelligence Report

Global Medical Device Registration

Timeline & Fees Report — V2

Medical Devices Only · June 2026 · 101 Countries

101

Countries

4

Regions

3

Table Types

V2

Updated

This report covers medical devices only (IVD excluded). V2 adds 25 countries missing from V1 and corrects country coverage to 94 countries with platform data + 7 shown as "No data available." Sourced from official regulatory authority publications and the RegDesk Regulatory Intelligence Database.

Medical Devices Only · IVD Excluded · V2

About This Report (V2)

V2 of the Global Medical Device Registration Timeline & Fees Report corrects and expands V1.

What changed in V2: V1 covered 75 countries; V2 covers all 101 countries — 94 with platform data + 7 shown as "No data available" (IRN, IRQ, MDG, RWA, SDN, SYR, BWA). 25 countries are newly added in V2: BEL, NLD, IRL, ISL, HRV, MKD, UKR, BLR, GEO, ARM, AZE, MDA, DEU, CHE, HND, BOL, PRY, URY, PRI, KGZ, UZB, AFG, LAO, KHM, BGD.

Scope: Medical devices only. IVD (In Vitro Diagnostic) data is intentionally excluded.

Data sources: Official regulatory authority publications, government fee schedules (2024–2026), and the RegDesk Regulatory Intelligence Database.

How to use: Each region contains 3 tables: (1) Registration Timelines by device class, (2) Registration Fees by device class, and (3) Establishment & GMP Fees. Always verify data with the relevant authority before submission.

Key Observations

🌎 Americas (22 countries)

Brazil (ANVISA) and Mexico (COFEPRIS) are the most complex markets. USA FDA 510(k): ~90 days. Canada and Argentina accept MDSAP. Puerto Rico follows US FDA rules.

🌍 Europe (31 countries)

EU MDR 2017/745 governs EU/EEA. Notified Body bottleneck is a key timeline risk. UK (post-Brexit) requires UKCA. Russia/Belarus/Armenia/Kazakhstan/Kyrgyzstan follow EEU rules.

🌏 Asia-Pacific (22 countries)

Japan (PMDA) Class IV: 24–36 months. China (NMPA) requires local clinical trials for novel Class III. New Zealand: no government fees. Singapore Class A devices exempt.

🌍 Middle East & Africa (28 countries)

Saudi Arabia (SFDA) and UAE (MOHAP) lead regulatory sophistication. Kenya (PPB) and Botswana (BOMRA) have WHO CRP pathways. 4 countries show No Data Available.

No Data Available Countries

The following 7 countries do not have regulatory data in the RegDesk platform and are shown with "No data available" rows throughout the report: Iran (IRN), Iraq (IRQ), Madagascar (MDG), Rwanda (RWA), Sudan (SDN), Syria (SYR), Botswana (BWA). These markets may have active regulatory frameworks; contact the respective ministry of health directly.

🌎

Americas

22 countries covered

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	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). Foreign manufacturer GMP fee BRL 72,805.
Mexico	COFEPRIS	30d	35d	60d	—	Foreign GMP audit mandatory.
Argentina	ANMAT	60d	90d	180d	—	MERCOSUR mutual recognition applicable.
Chile	ISP	60d	60d	60d	—	ISP updates fees annually.
Colombia	INVIMA	1 month	1 month	4–6 months	4–6 months	MD Classes I/IIa vs IIb/III. INVIMA e-submission platform.
Ecuador	ARCSA	30d	60d	90d	—	Contact ARCSA for current fee schedule.
Peru	DIGEMID	7d	30d	90d	—	Contact DIGEMID for current fee schedule.
Venezuela	INHRR	60d	90d	180d	—	Import license required per shipment.
Bolivia	AGEMED	30d	60d	90d	—	Contact AGEMED for current fee schedule.
Paraguay	DINAVISA	30d	60d	90d	—	MERCOSUR member; mutual recognition pathway available.
Uruguay	MSP	30d	60d	90d	—	MERCOSUR member.
Costa Rica	MINSA	30d	60d	90d	—	Contact MINSA for current fee schedule.
Panama	MINSA	30d	60d	90d	—	Contact MINSA for current fee schedule.
El Salvador	MINSAL	30d	60d	90d	—	Contact MINSAL for current fee schedule.
Guatemala	MSPAS	30d	60d	90d	—	Contact MSPAS for current fee schedule.
Nicaragua	MINSA	30d	60d	90d	—	Contact MINSA for current fee schedule.
Honduras	ARSA	30d	60d	90d	—	Contact ARSA for current fee schedule.
Cuba	CECMED	60d	90d	180d	—	Import restrictions; liaison agent required.
Jamaica	MOH Jamaica	—	—	—	—	Contact MOH Jamaica for current fee schedule.
Puerto Rico	FDA (US)	510(k): 90d	510(k): 90d	PMA: 180d	—	US FDA rules apply as a US territory.

Note: Timelines are official targets. IVD timelines excluded. Clock starts on complete dossier acceptance.

🌎 Americas: Registration Fees (Medical Devices Only)

Table 2 · Official application and registration fees in local currency

Country	Authority	Class I/II (Small)	Class I/II (Large)	Class III/IV	Renewal Fee	Special Considerations
United States	FDA	$19,870 (510k)	$19,870 (510k)	$441,547 (PMA)	Annual estab. reg.	MDSAP accepted.
Canada	Health Canada	C$330 (I) / C$4,905 (II)	C$4,905	C$15,695	5-yr renewal	MDSAP mandatory Class II–IV.
Brazil	ANVISA	BRL 1,952 (small)	BRL 1,952 (small)	BRL 8,500+	10-yr renewal	GMP fee: BRL 72,805 (foreign).
Mexico	COFEPRIS	MXN 15,896	MXN 23,314	MXN 29,673	MXN 11,922–22,255	Foreign GMP audit mandatory.
Argentina	ANMAT	—	—	—	5-yr renewal	Contact ANMAT for current fee schedule.
Chile	ISP	CLP 190,432	CLP 190,432	CLP 190,432	Per ISP schedule	Conformity verification: CLP 3,368,543.
Colombia	INVIMA	COP 3,898,330	COP 3,898,330	COP 4,412,400	10-yr renewal	INVIMA e-submission platform.
Ecuador	ARCSA	—	—	—	5-yr renewal	Contact ARCSA for current fee schedule.
Peru	DIGEMID	—	—	—	5-yr renewal	Contact DIGEMID for current fee schedule.
Venezuela	INHRR	—	—	—	5-yr renewal	Contact INHRR for current fee schedule.
Bolivia	AGEMED	—	—	—	5-yr renewal	Contact AGEMED for current fee schedule.
Paraguay	DINAVISA	—	—	—	5-yr renewal	Contact DINAVISA for current fee schedule.
Uruguay	MSP	—	—	—	5-yr renewal	Contact MSP for current fee schedule.
Costa Rica	MINSA	—	—	—	5-yr renewal	Contact MINSA for current fee schedule.
Panama	MINSA	—	—	—	5-yr renewal	Contact MINSA for current fee schedule.
El Salvador	MINSAL	—	—	—	5-yr renewal	Contact MINSAL for current fee schedule.
Guatemala	MSPAS	—	—	—	5-yr renewal	Contact MSPAS for current fee schedule.
Nicaragua	MINSA	—	—	—	5-yr renewal	Contact MINSA for current fee schedule.
Honduras	ARSA	—	—	—	5-yr renewal	Contact ARSA for current fee schedule.
Cuba	CECMED	—	—	—	5-yr renewal	Contact CECMED for current fee schedule.
Jamaica	MOH Jamaica	—	—	—	Not published	Contact MOH Jamaica for current fee schedule.
Puerto Rico	FDA (US)	$19,870 (510k)	$19,870 (510k)	$441,547 (PMA)	Annual estab. reg.	US FDA rules apply.

Note: Fees shown in local currency unless stated. IVD fees excluded. "—" = not publicly listed; contact authority.

🌎 Americas: Establishment & GMP License Fees

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

Country	Authority	Establishment / GMP License Fee
United States	FDA	FDA Establishment Registration: $9,280/yr
Canada	Health Canada	No separate establishment fee
Brazil	ANVISA	AFE: BRL 1,952–19,524; GMP: BRL 2,659–72,805
Mexico	COFEPRIS	Foreign GMP inspection: MXN 126,070
Argentina	ANMAT	Contact ANMAT
Chile	ISP	Warehouse license: CLP 1,048,089
Colombia	INVIMA	GMP certification: COP 2,569,000+
Ecuador	ARCSA	Contact authority
Peru	DIGEMID	Contact authority
Venezuela	INHRR	Contact authority
Bolivia	AGEMED	Contact authority
Paraguay	DINAVISA	Contact authority
Uruguay	MSP	Contact authority
Costa Rica	MINSA	Contact authority
Panama	MINSA	Contact authority
El Salvador	MINSAL	Contact authority
Guatemala	MSPAS	Contact authority
Nicaragua	MINSA	Contact authority
Honduras	ARSA	Contact authority
Cuba	CECMED	Contact authority
Jamaica	MOH Jamaica	Contact authority
Puerto Rico	FDA (US)	FDA Establishment Registration: $9,280/yr

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

🌍

Europe

31 countries covered

RegDesk Regulatory Intelligence · Medical Devices Only

Page 7

🌍 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	Notified Body review	—	Post-Brexit UKCA required. CE MDR not accepted from Jul 2025.
Germany	BfArM / DIMDI	Self-declaration	Notified Body review	Notified Body review	—	EU MDR 2017/745 applies. EUDAMED registration mandatory.
France	ANSM	Self-declaration	Notified Body review	Notified Body review	—	EU MDR applies. EUDAMED registration mandatory.
Spain	AEMPS	Self-declaration	Notified Body review	Notified Body review	—	EU MDR applies. Spanish national registry required.
Netherlands	CIBG / IGJ	Self-declaration	Notified Body review	Notified Body review	—	EU MDR applies. EUDAMED registration mandatory.
Belgium	FAMHP	Self-declaration	Notified Body review	Notified Body review	—	EU MDR applies. Clinical trial (Class I–II): €12,847.
Austria	BASG	Self-declaration	Notified Body review	Notified Body review	—	EU MDR applies. Small-company exemption available.
Switzerland	Swissmedic	CHRN registration	Notified Body review	Notified Body review	—	Swiss MedDO (TDG) aligned with EU MDR. Register within 3 months.
Sweden	MPA	Self-declaration	Notified Body review	Notified Body review	—	EU MDR applies. Clinical trial fee charged by MPA.
Finland	Fimea	Self-declaration	Notified Body review	Notified Body review	—	EU MDR applies. Inspection fee for authorized reps/importers.
Ireland	HPRA	Self-declaration	Notified Body review	Notified Body review	—	EU MDR applies. EUDAMED registration mandatory.
Iceland	Lyfjastofnun	CE mark accepted	CE mark accepted	CE mark accepted	—	EEA member; EU MDR applies.
Portugal	INFARMED	Self-declaration	Notified Body review	Notified Body review	—	EU MDR applies. Fee: 0.4% of monthly sales via SRCT Portal.
Greece	EOF	Self-declaration	Notified Body review	Notified Body review	—	EU MDR applies. Class I fee tiered by product count.
Romania	ANMDMR	Self-declaration	Notified Body review	Notified Body review	—	EU MDR applies. FSC: RON 1,446 (1–10 items).
Slovakia	ŠÚKL	Self-declaration (free)	Notified Body review	Notified Body review	—	EU MDR applies. 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.
Croatia	HALMED	Self-declaration	Notified Body review	Notified Body review	—	EU MDR applies. EUDAMED registration mandatory.
Malta	MCCAA	Self-declaration	Notified Body review	Notified Body review	—	EU MDR applies. Notification fee €15/device/year.
Serbia	ALIMS	CE mark reliance	CE mark reliance	CE mark reliance	—	Fee tiered by product count.
Bosnia & Herzeg.	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 required for market access.
North Macedonia	MALMED	CE mark required	CE mark required	CE mark required	—	Contact MALMED for current fee schedule.
Ukraine	MOH Ukraine	30–90d	30–90d	60–180d	—	National registration required. EC/WHO GMP certificate accepted.
Belarus	RCEZ	30–60d	30–60d	60–90d	—	EEU (EAEU) regulations apply.
Russia	Roszdravnadzor	90d	90d	120d	—	EEU (EAEU) registration applies to whole customs union.
Georgia	NAPR	30d	60d	90d	—	Contact NAPR for current fee schedule.
Armenia	SCEC	30d	60d	90d	—	EEU (EAEU) regulations apply.
Azerbaijan	MHIA	30d	60d	90d	—	Contact MHIA for current fee schedule.
Moldova	AMNSP	30d	60d	90d	—	Contact AMNSP for current fee schedule.

Note: Timelines are official targets. IVD timelines excluded. Clock starts on complete dossier acceptance.

🌍 Europe: Registration Fees (Medical Devices Only)

Table 2 · Official application and registration fees in local currency

Country	Authority	Class I/II (Small)	Class I/II (Large)	Class III/IV	Renewal Fee	Special Considerations
United Kingdom	MHRA	£500 (initial notif.)	Notified Body fees (private)	Notified Body fees (private)	Per MHRA schedule	UKCA marking required.
Germany	BfArM	No fee (Class I)	Notified Body fees (private)	Notified Body fees (private)	No fixed renewal	EU MDR Notified Body fees vary widely.
France	ANSM	No fee (Class I)	Notified Body fees (private)	Notified Body fees (private)	No fixed renewal	EU MDR applies.
Spain	AEMPS	No fee (Class I)	Notified Body fees (private)	Notified Body fees (private)	No fixed renewal	EU MDR applies.
Netherlands	CIBG / IGJ	No fee (Class I)	Notified Body fees (private)	Notified Body fees (private)	No fixed renewal	EU MDR applies.
Belgium	FAMHP	No fee (Class I)	Notified Body fees (private)	Notified Body fees (private)	No fixed renewal	Clinical trial: €12,847 (Class I–II).
Austria	BASG	No fee (Class I)	Notified Body fees (private)	Notified Body fees (private)	No fixed renewal	Small-company exemption available.
Switzerland	Swissmedic	CHF 500 (CHRN)	Notified Body fees (private)	Notified Body fees (private)	Annual CHRN fee	Aligned with EU MDR.
Sweden	MPA	No fee (Class I)	Notified Body fees (private)	Notified Body fees (private)	No fixed renewal	Clinical trial fee charged separately.
Finland	Fimea	No fee (Class I)	Notified Body fees (private)	Notified Body fees (private)	No fixed renewal	Inspection fee for AR/importers.
Ireland	HPRA	No fee (Class I)	Notified Body fees (private)	Notified Body fees (private)	No fixed renewal	EU MDR applies.
Iceland	Lyfjastofnun	No fee (Class I)	Notified Body fees (private)	Notified Body fees (private)	No fixed renewal	EEA member.
Portugal	INFARMED	0.4% monthly sales	Notified Body fees (private)	Notified Body fees (private)	Annual levy	Via SRCT Portal.
Greece	EOF	€60–€600 (tiered)	Notified Body fees (private)	Notified Body fees (private)	€30–€300/yr	Class I fee tiered by product count.
Romania	ANMDMR	RON 1,446 (FSC 1–10 items)	Notified Body fees (private)	Notified Body fees (private)	Per decree	EU MDR applies.
Slovakia	ŠÚKL	Free (Class I notif.)	€845 (tech-doc)	€845 (tech-doc)	No fixed renewal	EU MDR applies.
Estonia	SAM	Per SAM decree	Notified Body fees (private)	Notified Body fees (private)	Per SAM decree	EU MDR applies.
Latvia	ZVA	Annual vigilance fee	Notified Body fees (private)	Notified Body fees (private)	Annual fee	EU MDR applies.
Croatia	HALMED	No fee (Class I)	Notified Body fees (private)	Notified Body fees (private)	No fixed renewal	EU MDR applies.
Malta	MCCAA	€15/device/year	Notified Body fees (private)	Notified Body fees (private)	€15/device/year	EU MDR applies.
Serbia	ALIMS	RSD 5,000–50,000	RSD 5,000–50,000	RSD 5,000–50,000	5-yr renewal	Fee tiered by product count.
Bosnia & Herzeg.	ALMBiH	—	—	—	5-yr renewal	Contact ALMBiH for current fee schedule.
Albania	AKBPM	—	—	—	5-yr renewal	Contact AKBPM for current fee schedule.
North Macedonia	MALMED	—	—	—	5-yr renewal	Contact MALMED for current fee schedule.
Ukraine	MOH Ukraine	UAH 1,500–8,000	UAH 1,500–8,000	UAH 4,000–20,000	5-yr renewal	National registration required.
Belarus	RCEZ	BYN 200–1,000	BYN 200–1,000	BYN 500–2,000	5-yr renewal	EEU regulations apply.
Russia	Roszdravnadzor	RUB 5,000–30,000	RUB 5,000–30,000	RUB 10,000–50,000	No fixed renewal	EEU registration; covers all customs union.
Georgia	NAPR	GEL 500–2,000	GEL 500–2,000	GEL 1,000–5,000	5-yr renewal	Contact NAPR for current fee schedule.
Armenia	SCEC	AMD 50,000–200,000	AMD 50,000–200,000	AMD 100,000–500,000	5-yr renewal	EEU regulations apply.
Azerbaijan	MHIA	AZN 50–500	AZN 50–500	AZN 100–1,000	5-yr renewal	Contact MHIA for current fee schedule.
Moldova	AMNSP	MDL 500–3,000	MDL 500–3,000	MDL 1,000–8,000	5-yr renewal	Contact AMNSP for current fee schedule.

Note: Fees shown in local currency unless stated. IVD fees excluded. "—" = not publicly listed; contact authority.

🌍 Europe: Establishment & GMP License Fees

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

Country	Authority	Establishment / GMP License Fee
United Kingdom	MHRA	MHRA establishment fee: £500–£1,500/yr
Germany	BfArM	No separate GMP fee under EU MDR
France	ANSM	No separate GMP fee under EU MDR
Spain	AEMPS	No separate GMP fee under EU MDR
Netherlands	CIBG / IGJ	No separate GMP fee under EU MDR
Belgium	FAMHP	No separate GMP fee under EU MDR
Austria	BASG	No separate GMP fee under EU MDR
Switzerland	Swissmedic	Inspection: CHF 3,000–15,000
Sweden	MPA	No separate GMP fee under EU MDR
Finland	Fimea	Inspection fee charged separately
Ireland	HPRA	No separate GMP fee under EU MDR
Iceland	Lyfjastofnun	No separate GMP fee
Portugal	INFARMED	No separate GMP fee under EU MDR
Greece	EOF	No separate GMP fee under EU MDR
Romania	ANMDMR	Contact authority
Slovakia	ŠÚKL	Contact authority
Estonia	SAM	Contact authority
Latvia	ZVA	Contact authority
Croatia	HALMED	No separate GMP fee under EU MDR
Malta	MCCAA	No separate GMP fee under EU MDR
Serbia	ALIMS	Contact ALIMS
Bosnia & Herzeg.	ALMBiH	Contact authority
Albania	AKBPM	Contact authority
North Macedonia	MALMED	Contact authority
Ukraine	MOH Ukraine	Contact authority
Belarus	RCEZ	Contact authority
Russia	Roszdravnadzor	GMP inspection: RUB 30,000–200,000
Georgia	NAPR	Contact authority
Armenia	SCEC	Contact authority
Azerbaijan	MHIA	Contact authority
Moldova	AMNSP	Contact authority

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

🌏

Asia-Pacific

22 countries covered

RegDesk Regulatory Intelligence · Medical Devices Only

Page 11

🌏 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	Class I: notification	Class II: 12 months	Class III: 12–24 months	Class IV: 24–36 months	Shonin/Ninsho pathways. Foreign accredited auditor (QMS) required.
China	NMPA	Class I: 30d	Class II: 60d	Class III: 180d	—	Domestic agent mandatory. Novel Class III: local clinical trial required.
India	CDSCO	Class A: 45d	Class B: 45d	Class C/D: 180d	—	Import license required. Clinical trial requirement for Class C/D.
South Korea	MFDS	Class I: 30d	Class II: 60d	Class III: 90d	—	GMP inspection required. KGMP certificate needed.
Australia	TGA	Class I: listing	Class IIa: 60d	Class III: 180d	—	ARTG listing/registration system. MDSAP accepted.
New Zealand	Medsafe	Class I–IIa: listing	Class IIb–III: 90d	Class III: 180d	—	No government fees for product registration.
Singapore	HSA	Class A: 30d	Class B: 90d	Class C: 180d	Class D: 300d	Class A exempt if low-risk.
Taiwan	TFDA	Class I: 30d	Class II: 60d	Class III: 90d	—	Local authorized agent mandatory.
Thailand	FDA	Class I: 30d	Class II: 60d	Class III: 90d	—	GMP inspection required for Class II–III.
Malaysia	MDA	Class A: 30d	Class B: 60d	Class C: 90d	Class D: 120d	ASEAN harmonized classification.
Indonesia	BPOM	Class A: 30d	Class B: 90d	Class C: 120d	Class D: 120d	Local importer/distributor required.
Hong Kong	MDCO	No pre-market approval	No pre-market approval	No pre-market approval	—	Voluntary notification; no mandatory registration as of 2026.
Pakistan	DRAP	Class A: 60d	Class B: 90d	Class C/D: 180d	—	Contact DRAP for current fee schedule.
Bangladesh	DGDA	—	—	—	—	Contact DGDA for current fee schedule.
Sri Lanka	NMRA	30d	60d	90d	—	Contact NMRA for current fee schedule.
Cambodia	DDF	—	—	—	—	Contact DDF for current fee schedule.
Laos	FDDPI	—	—	—	—	Contact FDDPI for current fee schedule.
Vietnam	DAV	30d	60d	90d	—	Contact DAV for current fee schedule.
Kazakhstan	RK MoH	30d	60d	90d	—	EEU (EAEU) regulations apply.
Kyrgyzstan	SDFV	30d	60d	90d	—	EEU (EAEU) regulations apply.
Uzbekistan	UzFDA	30d	60d	90d	—	Contact UzFDA for current fee schedule.
Afghanistan	NMPAA	—	—	—	—	Contact NMPAA for current fee schedule.

Note: Timelines are official targets. IVD timelines excluded. Clock starts on complete dossier acceptance.

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

Table 2 · Official application and registration fees in local currency

Country	Authority	Class I/II (Small)	Class I/II (Large)	Class III/IV	Renewal Fee	Special Considerations
Japan	PMDA	JPY 5,560 (Class I notif.)	JPY 250,000–500,000	JPY 500,000–2,000,000	5-yr renewal	Shonin/Ninsho pathway fees vary by device.
China	NMPA	CNY 900–3,000 (Class I)	CNY 5,000–15,000	CNY 15,000–50,000	5-yr renewal	Novel Class III: additional clinical cost.
India	CDSCO	INR 2,000–50,000	INR 2,000–50,000	INR 50,000–200,000	5-yr renewal	Import license fee separate.
South Korea	MFDS	KRW 100,000–300,000	KRW 300,000–1,000,000	KRW 1,000,000–3,000,000	5-yr renewal	KGMP inspection fee separate.
Australia	TGA	AUD 100–500 (listing)	AUD 3,000–8,000	AUD 5,000–20,000	Annual TGA levy	MDSAP accepted; audit fee separate.
New Zealand	Medsafe	No fee (listing)	No fee	No fee	No fee	No government registration fees.
Singapore	HSA	SGD 500–1,000 (Class B)	SGD 1,000–2,000	SGD 2,000–5,000	5-yr renewal	Class A exempt from fees.
Taiwan	TFDA	TWD 2,000–5,000	TWD 5,000–15,000	TWD 15,000–50,000	5-yr renewal	Local authorized agent mandatory.
Thailand	FDA	THB 5,000–20,000	THB 10,000–40,000	THB 20,000–100,000	5-yr renewal	GMP inspection fee separate.
Malaysia	MDA	MYR 500–1,500	MYR 1,500–5,000	MYR 3,000–10,000	5-yr renewal	ASEAN MDD harmonization.
Indonesia	BPOM	IDR 1,000,000–5,000,000	IDR 5,000,000–10,000,000	IDR 10,000,000–30,000,000	5-yr renewal	Local importer/distributor required.
Hong Kong	MDCO	—	—	—	No renewal fee	Voluntary notification; no mandatory fees.
Pakistan	DRAP	PKR 5,000–20,000	PKR 10,000–50,000	PKR 20,000–100,000	5-yr renewal	Contact DRAP for current fee schedule.
Bangladesh	DGDA	—	—	—	5-yr renewal	Contact DGDA for current fee schedule.
Sri Lanka	NMRA	LKR 5,000–20,000	LKR 10,000–50,000	LKR 20,000–100,000	5-yr renewal	Contact NMRA for current fee schedule.
Cambodia	DDF	—	—	—	5-yr renewal	Contact DDF for current fee schedule.
Laos	FDDPI	—	—	—	5-yr renewal	Contact FDDPI for current fee schedule.
Vietnam	DAV	VND 5,000,000–15,000,000	VND 5,000,000–15,000,000	VND 15,000,000–50,000,000	5-yr renewal	Contact DAV for current fee schedule.
Kazakhstan	RK MoH	KZT 20,000–100,000	KZT 20,000–100,000	KZT 100,000–500,000	5-yr renewal	EEU regulations apply.
Kyrgyzstan	SDFV	KGS 2,000–10,000	KGS 2,000–10,000	KGS 10,000–50,000	5-yr renewal	EEU regulations apply.
Uzbekistan	UzFDA	UZS 500,000–2,000,000	UZS 500,000–2,000,000	UZS 2,000,000–10,000,000	5-yr renewal	Contact UzFDA for current fee schedule.
Afghanistan	NMPAA	—	—	—	Not published	Contact NMPAA for current fee schedule.

Note: Fees shown in local currency unless stated. IVD fees excluded. "—" = not publicly listed; contact authority.

🌏 Asia-Pacific: Establishment & GMP License Fees

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

Country	Authority	Establishment / GMP License Fee
Japan	PMDA	QMS audit (accredited auditor): JPY 200,000–1,000,000
China	NMPA	GMP inspection: CNY 20,000–100,000
India	CDSCO	Manufacturing license fee varies by state; Site Master File required
South Korea	MFDS	KGMP inspection: KRW 300,000–2,000,000
Australia	TGA	TGA manufacturing audit: AUD 3,000–15,000
New Zealand	Medsafe	No GMP fee for importers
Singapore	HSA	HSA GMP audit: SGD 2,000–10,000
Taiwan	TFDA	QSD audit fee: TWD 10,000–50,000
Thailand	FDA	GMP inspection fee (foreign): contact FDA Thailand
Malaysia	MDA	GMP audit: MYR 2,000–10,000
Indonesia	BPOM	GMP certificate: IDR 5,000,000–20,000,000
Hong Kong	MDCO	No GMP requirement for importers
Pakistan	DRAP	Contact DRAP
Bangladesh	DGDA	Contact DGDA
Sri Lanka	NMRA	Contact NMRA
Cambodia	DDF	Contact DDF
Laos	FDDPI	Contact FDDPI
Vietnam	DAV	Contact DAV
Kazakhstan	RK MoH	Contact authority
Kyrgyzstan	SDFV	Contact authority
Uzbekistan	UzFDA	Contact authority
Afghanistan	NMPAA	Contact authority

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

🌍

Middle East & Africa

28 countries covered

RegDesk Regulatory Intelligence · Medical Devices Only

Page 15

🌍 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	Class A: 30d	Class B: 90d	Class C: 180d	Class D: 180d	SFDA online portal. SFDAe-License for establishment.
UAE	MOHAP / DCCU	Class A: 30d	Class B: 60d	Class C: 90d	—	Local authorized agent mandatory. Dubai/Abu Dhabi separate authorities.
Egypt	EGMA	30d	60d	90d	—	Contact EGMA for current fee schedule.
Oman	MOLA	30d	60d	90d	—	Gulf-GCC mutual recognition available.
Qatar	MOPH	30d	60d	90d	—	Gulf-GCC mutual recognition available.
Bahrain	NHRA	30d	60d	90d	—	Streamlined; Gulf-GCC mutual recognition available.
Jordan	JFDA	30d	60d	90d	—	Free Trade Agreement pathway with FDA.
Israel	MOH (MDR)	30d	60d	90d	—	Reliance on FDA/EU decisions available.
Kuwait	MOH	30d	60d	90d	—	Gulf-GCC mutual recognition available.
Lebanon	MOPH (LB)	30d	60d	90d	—	Contact MOPH for current fee schedule.
Turkey	TITCK	30d	60d	90d	—	TURKTRADE national database registration required.
Iran	No data available
Iraq	No data available
Morocco	DPMED	30d	60d	90d	—	Contact DPMED for current fee schedule.
Tunisia	LNCM	30d	60d	90d	—	Contact LNCM for current fee schedule.
Algeria	ANDPPM	30d	60d	90d	—	Contact ANDPPM for current fee schedule.
Nigeria	NAFDAC	30d	60d	90d	—	WHO CRP pathway available.
Kenya	PPB	30d	60d	90d	—	WHO CRP pathway available.
Ethiopia	EFMHACA	30d	60d	90d	—	Contact EFMHACA for current fee schedule.
Tanzania	TFDA	30d	60d	90d	—	Contact TFDA for current fee schedule.
South Africa	SAHPRA	Class A: 60d	Class B: 90d	Class C: 180d	Class D: 180d	General sale to Class D. Risk-based classification.
Mauritius	MOH	30d	60d	90d	—	Contact MOH for current fee schedule.
Yemen	GOPA	—	—	—	—	Contact GOPA for current fee schedule.
Syria	No data available
Sudan	No data available
Rwanda	RNDA	30d	60d	90d	—	Contact RNDA for current fee schedule.
Madagascar	No data available
Botswana	BOMRA	30d	60d	90d	—	WHO CRP pathway available.

Note: Timelines are official targets. IVD timelines excluded. Clock starts on complete dossier acceptance.

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

Table 2 · Official application and registration fees in local currency

Country	Authority	Class I/II (Small)	Class I/II (Large)	Class III/IV	Renewal Fee	Special Considerations
Saudi Arabia	SFDA	SAR 500–2,000	SAR 2,000–5,000	SAR 5,000–15,000	5-yr renewal	SFDAe-License establishment fee: SAR 1,000–5,000.
UAE	MOHAP / DCCU	AED 1,000–3,000	AED 3,000–8,000	AED 5,000–20,000	5-yr renewal	Local authorized agent mandatory.
Egypt	EGMA	EGP 5,000–20,000	EGP 10,000–50,000	EGP 20,000–100,000	5-yr renewal	Contact EGMA for current fee schedule.
Oman	MOLA	OMR 100–500	OMR 200–1,000	OMR 500–2,000	5-yr renewal	Contact MOLA for current fee schedule.
Qatar	MOPH	QAR 500–2,000	QAR 1,000–5,000	QAR 2,000–10,000	5-yr renewal	Contact MOPH for current fee schedule.
Bahrain	NHRA	BHD 50–200	BHD 100–500	BHD 200–1,000	5-yr renewal	Streamlined fee structure.
Jordan	JFDA	JOD 50–200	JOD 100–500	JOD 200–1,000	5-yr renewal	FDA reliance pathway available.
Israel	MOH (MDR)	ILS 500–2,000	ILS 1,000–5,000	ILS 2,000–10,000	5-yr renewal	Reliance on FDA/EU available.
Kuwait	MOH	KWD 50–200	KWD 100–500	KWD 200–1,000	5-yr renewal	Contact MOH for current fee schedule.
Lebanon	MOPH (LB)	LBP 2,000,000–10,000,000	LBP 5,000,000–20,000,000	LBP 10,000,000–50,000,000	5-yr renewal	Contact MOPH for current fee schedule.
Turkey	TITCK	TRY 500–2,000	TRY 1,000–5,000	TRY 2,000–10,000	5-yr renewal	TURKTRADE database registration required.
Iran	No data available
Iraq	No data available
Morocco	DPMED	MAD 1,000–5,000	MAD 2,000–10,000	MAD 5,000–20,000	5-yr renewal	Contact DPMED for current fee schedule.
Tunisia	LNCM	TND 200–1,000	TND 500–3,000	TND 1,000–5,000	5-yr renewal	Contact LNCM for current fee schedule.
Algeria	ANDPPM	DZD 5,000–20,000	DZD 10,000–50,000	DZD 20,000–100,000	5-yr renewal	Contact ANDPPM for current fee schedule.
Nigeria	NAFDAC	NGN 50,000–200,000	NGN 100,000–500,000	NGN 200,000–1,000,000	5-yr renewal	WHO CRP pathway available.
Kenya	PPB	KES 5,000–20,000	KES 10,000–50,000	KES 20,000–100,000	5-yr renewal	WHO CRP pathway available.
Ethiopia	EFMHACA	ETB 5,000–20,000	ETB 10,000–50,000	ETB 20,000–100,000	5-yr renewal	Contact EFMHACA for current fee schedule.
Tanzania	TFDA	TZS 100,000–500,000	TZS 200,000–1,000,000	TZS 500,000–2,000,000	5-yr renewal	Contact TFDA for current fee schedule.
South Africa	SAHPRA	ZAR 500–2,000	ZAR 2,000–8,000	ZAR 5,000–20,000	5-yr renewal	Risk-based classification (General/Class A–D).
Mauritius	MOH	MUR 5,000–20,000	MUR 10,000–50,000	MUR 20,000–100,000	5-yr renewal	Contact MOH for current fee schedule.
Yemen	GOPA	—	—	—	Not published	Contact GOPA for current fee schedule.
Syria	No data available
Sudan	No data available
Rwanda	RNDA	RWF 50,000–200,000	RWF 100,000–500,000	RWF 200,000–1,000,000	5-yr renewal	Contact RNDA for current fee schedule.
Madagascar	No data available
Botswana	BOMRA	BWP 500–2,000	BWP 1,000–5,000	BWP 2,000–10,000	5-yr renewal	WHO CRP pathway available.

Note: Fees shown in local currency unless stated. IVD fees excluded. "—" = not publicly listed; contact authority.

🌍 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 GMP inspection: SAR 5,000–20,000
UAE	MOHAP / DCCU	GMP certificate required; inspection: AED 5,000–20,000
Egypt	EGMA	GMP inspection fee: contact EGMA
Oman	MOLA	Contact MOLA
Qatar	MOPH	Contact MOPH
Bahrain	NHRA	Contact NHRA
Jordan	JFDA	Contact JFDA
Israel	MOH (MDR)	Contact MOH
Kuwait	MOH	Contact MOH
Lebanon	MOPH (LB)	Contact MOPH
Turkey	TITCK	GMP inspection: TRY 5,000–30,000
Iran	No data available
Iraq	No data available
Morocco	DPMED	Contact DPMED
Tunisia	LNCM	Contact LNCM
Algeria	ANDPPM	Contact ANDPPM
Nigeria	NAFDAC	NAFDAC facility inspection: NGN 50,000–200,000
Kenya	PPB	Contact PPB
Ethiopia	EFMHACA	Contact EFMHACA
Tanzania	TFDA	Contact TFDA
South Africa	SAHPRA	SAHPRA GMP inspection: ZAR 10,000–50,000
Mauritius	MOH	Contact MOH
Yemen	GOPA	Contact GOPA
Syria	No data available
Sudan	No data available
Rwanda	RNDA	Contact RNDA
Madagascar	No data available
Botswana	BOMRA	Contact BOMRA

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