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Medical Equipment Compliance
Certification and Regulatory
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In the United States, the FDA (Food and Drug Administration) Center for Devices and Radiological Health (CDRH) is responsible for regulating firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States. Medical devices are classified into Class I, II, and III, based on their risk. The device classification defines the regulatory requirements, which increases from Class I to Class III. Most Class I devices are exempt from 510(k) Premarket Notification, most Class II devices require 510(k) Premarket Notification, and most Class III devices require PMA (Premarket Approval). Except for 510(k) exempt devices, you cannot market the device in the US until you receive a letter from FDA authorizing you
to do so. To place the device on the market, there are additional FDA requirements, including annual registration for the production and distribution facilities (establishment registration), listing of the medical devices that are made and activities performed on the devices (listing), and paying the required fees. Manufacturing facilities are also required to meet the GMP (Good Manufacturing Practice) requirements.
The Federal Food, Drug, and Cosmetic Act requires all medical devices be “safe and effective”. The FDA recognizes consensus safety standards as a means to support this, with a declaration of conformity, per the 510(k) paradigm and PMA (Pre-Market Approval) processes. AAMI (the Association for the Advancement of Medical Instrumentation) published ES 60601-1, which is a US recognized consensus standard. The third edition with
Amendment 1 (AAMI ES 60601-1:2005(R)2012+A1:2012) is the edition of the base standard that the FDA currently recognizes. The third edition
without amendment 1 (AAMI ES60601-1:2005) will only be recognized by the FDA until 2016-08-01. The FDA typically gives three years for medical manufacturers to comply with new standards, before they’re required.
Devices that have already been cleared by the FDA are not required to be re-submitted based on changes to the standards, unless there are changes to the device that require a 510(k) submission. See the FDA 510(k) Memorandum #K97-1 (Deciding When to Submit a 510(k) for a Change to an Existing Device) to determine if this is required for your change.
The US also has the NRTL (Nationally Recognized Testing Laboratory) program, which is administered by OSHA (the Occupational and Safety Health Administration). This program controls the US Safety Marks, such as UL, TUV Rheinland, TUV SUD, Intertek/ETL, CSA, SGS, MET Labs, and others. Almost all hospitals and many healthcare facilities in the US require an NRTL safety mark on medical devices they purchase. This is typically enforced by the Clinical Engineering staff, who will not place a medical device into service, unless it has an NRTL Safety Mark on it. This is not, however, required by the FDA to place a medical device on the US market.
The authorization to apply an NRTL Safety Mark on products comes from the certification agency that has evaluated it to the applicable standards that OSHA recognizes. OSHA currently recognizes UL 60601-1 (based on the second edition of IEC 60601-1) and AAMI ES 60601-1:2005(R)2012+A1:2012 (based on the third edition of IEC 60601-1, with amendment 1). You should also be aware that OSHA requires the NRTL to conduct manufacturing inspections two or four times a year to ensure that the medical device that’s being manufactured has the same construction as the device that was tested. When there are changes to a medical device with an NRTL Safety Mark, the changes must be reviewed to determine if retesting and/or report revisions are required.
Canada - Health Canada, SCC Certification Body Safety Marks
In Canada, medical devices are regulated by Health Canada’s Therapeutic Products Directorate and are subject to the Medical Devices Regulations under the Food and Drugs Act. Medical devices must have a license before they can be placed on the market in Canada. Health Canada groups devices as Class I, II, III, or IV, based on their risk. These risks include the degree of invasiveness, duration of patient contact, hazards from energy transmission, and the consequences of device failure and faults. Class I devices have the lowest risk and do not require a license. Class II devices require a manufacturer’s declaration of device safety and effectiveness. Class III and Class IV devices present a higher risk, so they are subject to higher regulatory scrutiny before the device can be placed on the market.
Health Canada recognizes standards for medical devices, used to demonstrate safety and effectiveness. The CSA C22.2 No. 60601-1:2008 standard (based on the third edition of IEC 60601-1), as well as the IEC 60601-1, Edition 3 standard are both listed as a recognized standards. The CSA C22.2 No. 60601-1:14 standard (based on the third edition of IEC 60601-1, with amendment 1) is accepted by Health Canada, but has not yet been added to the list of recognized medical standards. Health Canada typically gives three years for medical manufacturers to comply with new standards before they’re required. The MECA GMSU provides a current list of all Health Canada's recognized medical standards.
Canada also has Certification Body accreditation, administered by the SCC (Standards Council of Canada). This is similar to the US NRTL Mark program, and covers Canadian safety certification marks. The accredited Certification Bodies include CSA (Canadian Standards Association), UL,
TUV Rheinland, TUV SUD, Intertek/ETL, SGS, MET Labs, and others. Typically, the safety mark will have the certification agency's mark with a "US" and a "C" next to it, showing that it covers both the US NRTL requirements and the Canadian SCC requirements. As in the US, almost all hospitals and many healthcare facilities in Canada require an NRTL safety mark on medical devices they purchase. This is typically enforced by the Clinical Engineering staff, who will not place a medical device into service, unless it has an SCC accredited Safety Mark on it. The authorization to apply an SCC accredited Safety Mark on products comes from the accredited agency that has evaluated it to the applicable standards that the SCC recognizes. The SCC currently recognizes CSA C22.2 No. 601.1 (based on the second edition of IEC 60601-1), CSA C22.2 No. 60601-1:2008 (based on the third edition of IEC 60601-1), and CSA C22.2 No. 60601-1:14 (based on the third edition of IEC 60601-1, with amendment 1). You should also be aware that like the US, the SCC requires the certification agency to conduct manufacturing inspections two or four times a year to ensure that the medical device that’s being manufactured has the same construction as the device that was tested. When there are changes to a medical device with an SCC Certification Mark, the changes must be reviewed to determine if retesting and/or report revisions are required.
European Union - MDD (Medical Device Directive), CE Marking
Australia - TGA (Therapeutic Goods Administration)
China - CFDA
The CFDA (China Food and Drug Administration) was the SFDA (State Food and Drug Administration) prior to March, 2013.
All medical devices are classified into 3 classes by the CFDA: Class 1 (testing typically required), Class 2 (testing always required, clinical trials typically required), Class 3 (testing always required, clinical trials always required). Link to CFDA
Contact MECA if you would like to keep track of the requirements for your products' regulatory requirements in China, through the MECA GMSU.
Japan - Japanese Ministry of Health & Welfare
Brazil - ANVISA (The Brazilian Health Surveillance Agency)