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.

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Marketsort descending 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 Low Risk (Sterile) Low 4-6 months
1
1
Egypt Moderate Risk (Sterile) Moderate 4-6 months
1
1
Egypt High Risk (Sterile) High 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 High Risk High 1-6 months
2
2
Israel Low Risk Low 1-6 months
2
2
Israel Moderate Risk Moderate 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 I Low 1 - 2 months
2
2
Taiwan Class II Moderate 10-12 months
3
2
Taiwan Class III High 10-12 months
3
3
United States Class II Moderate 6-9 months
3
4
United States Class III High 18-30 months
5
5
United States Class I Low <1 month
1
2

* The time frames shown above are typical for the majority of medical device submissions but assume that your device does not contain animal tissue, medicinal substances or employ entirely novel technology. Your length of approval will depend on the quality and completeness of your technical documentation and how much time you take to address additional information requests from authorities after submission. YOUR SUBMISSION(S) MAY TAKE MORE TIME THAN WHAT IS SHOWN ABOVE.

** Estimated costs includes registration application fees, product testing, in-country representation, submission preparation consulting and translation of documents. Does not include cost of implementing or auditing a quality management system compliant with ISO 13485 or US FDA 21 CFR Part 820, if applicable. LOW = Less than US$5000; LOW/MODERATE = US$5000-$15000; MODERATE = US$15000-$30000; MODERATE/HIGH = US$30000-$50000; HIGH = US$50000 or more.

*** Our rating of the complexity of the registration process is based on Emergo’s experience with thousands of submissions and the opinion of nearly 1,000 QA/RA professionals worldwide who were asked to rate the difficulty of registering a device in each country. The European CE Marking process is generally considered the mid-point to which all other markets are compared.