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

Market	Device class	Risk	TIME* from submission to approval	COST** of gaining regulatory approval	COMPLEXITY*** of registration process
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	2
Australia	Class III	High	7-14 months	2	5
Brazil	Class I and II Cadastro	Low	2-7 months	2	3
Brazil	Class III Registro	High	18-30 months	5	5
Brazil	Class IV Registro	High	18-30 months	5	5
Canada	Class I	Low	2-4 months	2	2
Canada	Class II	Low	1-2 months	1	1
Canada	Class III	High	4-5 months	3	4
Canada	Class IV	High	6-8 months	4	5
China	Class I	Low	<1 month	3	2
China	Class II	High	16-24 months	4	5
China	Class III	High	16-24 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	2
Costa Rica	Class I	Low	2-4 months	1	2
Costa Rica	Class II	Moderate	2-4 months	1	2
Costa Rica	Class III	High	6-8 months	1	3
Costa Rica	Class IV	High	7-9 months	1	4
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	<1 month	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	Unknown	1	1
Malaysia	Class B	Moderate	Unknown	1	1
Malaysia	Class C	High	Unknown	1	1
Malaysia	Class D	High	Unknown	1	1
Mexico	Low Risk	Low	1-3 months	1	1
Mexico	Class I	Low	4-10 months	2	3
Mexico	Class II	High	8-12 months	2	3
Mexico	Class III	High	8-12 months	2	3
Russia	Class I	Low	12-18 months	5	3
Russia	Class IIa	Low	12-18 months	5	5
Russia	Class IIb	High	18-24 months	5	5
Russia	Class III	High	18-24 months	5	5
Saudi Arabia	Low Risk	Low	3-5 months	3	3
Saudi Arabia	Moderate Risk	Moderate	3-5 months	3	3
Saudi Arabia	High Risk	High	3-5 months	3	3
Singapore	Class A Non-Sterile	Low	Not applicable	1	3
Singapore	Class A Sterile	Low	1 month	1	3
Singapore	Class B	Moderate	1-4 months	2	3
Singapore	Class C	High	4-6 months	2	3
Singapore	Class D	High	6-8 months	2	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	High	8 - 10 Months	3	2
Taiwan	Class III	High	8-10 Months	3	3
Turkey	Class I Non-Sterile	Low	< 1 month	1	1
Turkey	Class I Sterile	Low	< 1 month	1	1
Turkey	Class IIa	Moderate	< 1 month	1	1
Turkey	Class IIb	High	< 1 month	1	1
Turkey	Class III	High	< 1 month	1	1
United States	Class II	High	3 - 6 Months	3	4
United States	Class III	High	18 - 30 Months	5	5
United States	Class I	Low	1 Month	2	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.