{{ phone }} {{ location }}

Emergo by UL logo

     

Compare the time, cost and complexity of getting regulatory approval for medical devices

Use the interactive table below for planning purposes. It will give you a high level understanding of how long it typically takes to gain approval in popular markets worldwide, along with the cost of doing so. While this information applies to 80% of situations, your device may take longer to approve or may require a larger investment than the ranges provided below. Updated December 2017.

Market Device Class Risk TIME* from submission to approval COST** of gaining regulatory approval COMPLEXITY*** of registration process
Class I Non-Sterile Low < 1 month
1
1
Class I Sterile Low < 1 month
1
1
Class IIa Moderate < 1 month
1
1
Class IIb High < 1 month
1
1
Class III High < 1 month
1
1
Australia Class I Non-Sterile Low <1 month
1
1
Australia Class I Sterile Low 2-3 months
1
1
Australia Class IIa Moderate 2-3 months
1
1
Australia Class IIb High 2-3 months
1
1
Australia Class III High 7-14 months
2
3
Brazil Class I and II Cadastro Low 1-3 months
2
3
Brazil Class III Registro High 8-15 months
4
5
Brazil Class IV Registro High 8-15 months
4
5
Canada Class I Low 2-4 months
2
2
Canada Class II Low 1-2 months
1
2
Canada Class III High 4-5 months
3
4
Canada Class IV High 6-8 months
4
5
China Class I Low <1 month
2
2
China Class II High 12-20 months
5
5
China Class III High 12-22 months
5
5
Colombia Class I Low <1 month
1
1
Colombia Class IIa Moderate <1 month
1
1
Colombia Class IIb High 4-6 months
1
2
Colombia Class III High 4-6 months
1
1
Costa Rica Class I Low 2-4 months
1
2
Costa Rica Class II Moderate 2-4 months
1
2
Costa Rica Class III Moderate 2-4 months
2
3
Costa Rica Class IV High 2-4 months
2
3
Egypt High Risk (Sterile) High 4-6 months
1
1
Egypt Low Risk (Sterile) Low 4-6 months
1
1
Egypt Moderate Risk (Sterile) Moderate 4-6 months
1
1
Europe Class I Non-Sterile Low N/A
1
1
Europe Class I Sterile Low 3-5 months
3
2
Europe Class IIa Moderate 3-5 months
3
3
Europe Class IIb High 3-6 months
4
3
Europe Class III High 6-9 months
4
4
Hong Kong Class IV High 8-12 months
3
2
Hong Kong Class I Low Not applicable No rating No rating
Hong Kong Class II Moderate 8-12 months
2
2
Hong Kong Class III High 8-12 months
2
2
India Non-notified IVD High <1 month
1
1
India Notified Medical Device or IVD High 9-12 months
3
3
Israel Low Risk Low 1-6 months
2
2
Israel Moderate Risk Moderate 1-6 months
2
2
Israel High Risk High 1-6 months
2
2
Japan Class I - General Low <1 month
2
2
Japan Class II - Specified Controlled Low 3-5 months
4
3
Japan Class II - Controlled Moderate 7-9 months
5
4
Japan Class III - Highly Controlled High 9-11 months
5
4
Japan Class IV - Highly Controlled High 13-16 months
5
5
Malaysia Class A - Active/Sterile/Measuring Low 1-2 months
2
3
Malaysia Class B Moderate 3-4 months
2
3
Malaysia Class C High 6-7 months
2
3
Malaysia Class D High 7-8 months
2
3
Mexico Low Risk Low 1-3 months
2
2
Mexico Class I Low 3-10 months
3
3
Mexico Class II High 3-10 months
3
3
Mexico Class III High 3-10 months
3
3
Russia Class I Low 6-10 months
4
4
Russia Class IIa Low 8-12 months
5
5
Russia Class IIb High 8-12 months
5
5
Russia Class III High 8-12 months
5
5
Saudi Arabia Low Risk Low 1-6 months
2
3
Saudi Arabia Moderate Risk Moderate 1-6 months
3
2
Saudi Arabia High Risk High 1-6 months
3
2
Singapore Class A Non-Sterile Low Auto approval
1
1
Singapore Class A Sterile Low 1-2 months
1
2
Singapore Class B Moderate 1-4 months
2
2
Singapore Class C High 4-6 months
2
3
Singapore Class D High 6-8 months
3
3
South Korea Class I Low <1 month
2
1
South Korea Class II Moderate 4-6 months
4
4
South Korea Class III High 6-10 months
4
4
South Korea Class IV High 6-10 months
4
4
Taiwan Class II Moderate 10-12 months
3
2
Taiwan Class III High 10-12 months
3
3
Taiwan Class I Low 1 - 2 months
2
2
United States Class I Low <1 month
1
2
United States Class II Moderate 6-9 months
3
4
United States Class III High 18-30 months
5
5