Learn about what Global Medical Device Regulations regulatory stands for:
If you are strong exporter of medical devices, you should know about global medical device regulations.
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Canada
The Medical Devices Bureau of the Therapeutic Products Directorate (TPD) is the national authority of Health Canada responsible for medical device regulations in Canada. TPD monitors and evaluates safety, effectiveness and quality of diagnostic and therapeutic devices.
Medical devices are grouped into four classes (I, II, III, and IV) where Class I devices present the lowest risk and Class IV devices present the highest risk. Manufacturers of Class II, III and IV devices must obtain a Medical Device License prior to selling their device in Canada. Class I devices do not require a MDL, but are monitored through Establishment Licenses. All importers, distributors and manufacturers must obtain an establishment license.
The length of the medical device license application varies depending on the device classification. Class II License applications have target review time of 15 days; Class III license applications have target review time of 75 days; Class IV license applications have target review time of 90 days.
Class I medical devices do not require compliance to quality system requirements. However, all Class II, III and IV devices require a quality system certificate (ISO 13485:2003). Health Canada only accepts quality system certificates that have been issued by the third party auditing organization called Canadian Medical Devices Conformity Assessment System (CMDCAS).
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Europe
European Commission is the governing body responsible for creating legislations and directives for medical devices for all of European Union. Although Competent Authority, a governmental body oversees medical device approval in each EU country. The Competent Authority designate independent companies called Notified Bodies, which handle the review and approval process of medical device applications and provide CE marks.
Medical devices are grouped into four classes (l, lla, llb, and lll) based on their risk classification. Class I devices are low risk and Class III are high-risk devices.
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Korea
The Ministry of Food and Drug Safety (MFDS) governs the medical device regulations in Korea within Korea Food and Drug Administration (KFDA). All medical devices must obtain pre-market approval from KFDA. KFDA only issues product licenses to local based firms, therefore, all foreign manufacturers must submit applications and receive approvals through Korean importers/distributors. Medical devices must be approved for sale in the country-of-origin (manufacture) for consideration by the KFDA. Most Class II, III and IV devices require local type testing performed by the test labs in Korea and go through a formal premarket notification. Class I devices are subject to premarket notification.
Earlier this year, KFDA made few amendments to their Medical Devices Act. – All class IV devices require Summary Technical Documentation (STED) – All medical device registrants must comply with the IEC 60601-1 3rd Edition. – Changes to regulations for classification and grades.
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Kuwait
Currently medical devices do not require registration in Kuwait. Only an import permit is required, which can only be obtained through a local authorized representative.
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Malaysia
Malaysia is one of the emerging markets in Asia for medical device sales and manufacturing.
The Medical Device Authority (MDA) is the governing body for regulating medical devices in Malaysia. Currently, medical devices are not regulated in Malaysia and neither is it necessary to obtain establishment license. However, in the near future, medical devices will need to be registered prior to sale or commerce through the new “Medical Device Act”.Medical Device Act was established in 2012 and came into effect July 1, 2013. A transition period of one year will be provided to the government for attaining establishment license before it is fully enforced in 2014.
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Qatar
Currently medical devices do not require registration in Qatar. Only an import permit is required, which can only be obtained through a local authorized representative.
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Saudi Arabia
The agency that governs the medical device industry in Kingdom of Saudi Arabia (KSA) is the Saudi Food and Drug Authority (SFDA). All medical devices are regulated in KSA. Foreign manufacturers must have existing approvals in at least one of the Global Harmonization Task Force (GHTF) member countries and the product classification is determined from the existing approval.
All product applications must be submitted through the Saudi Arabia authorized representative (AR). Only an AR can enroll the medical device in the Saudi Medical Device National Registry (MDNR) and submit documents via Medical Device Marketing Authorization (MDMA) system.
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Singapore
The Health Sciences Authority (HSA) administers the medical device regulations in Singapore. All medical devices Class A, B, C and D are regulated in Singapore with Class A being the lowest risk to Class D being the highest risk. The device classification in Singapore is similar to that of the EU and Global Harmonization Task Force (GHTF).
Most Class A devices are exempt from product registration and can be distributed for sale or commerce immediately.
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UAE
The UAE Ministry of Health (the Ministry) regulates medical devices in the UAE. Medical devices are regulated in the UAE and require pre-market approval prior to sale. Foreign manufacturers must go through an authorized representative to register the devices. The Ministry follows either the US FDA or the EU Medical Device Directive 93/42/EEC for device classification and evaluation. The foreign manufacturer must have an existing approval from at least one of the GHTF member countries. Devices are classified as Class I, IIa, IIb, III and active implantable devices.
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USA
Medical devices in the USA are regulated by the Food and Drug Administration’s (FDA) center for Devices and Radiological Health (CDRH). All firms who manufacture, repackage, relabel, and import medical devices sold in the USA are responsible for complying with the FDA regulations.
Medical devices in the US are classified into Class I, II and III where Class I are low risk devices and III are high-risk devices. Most class I devices are exempt from Premarket Notification 510(K); most class II devices require Premarket Notification 510(K); and most class III devices require Premarket Approval (PMA).
Acceptance review time for 510(k) is 15 days; substantive review is usually completed within 60 days. The applicant has up to 180 days to respond to Additional Information requests by the FDA.
Global medical device regulations for: manufacturers and importers must register their establishments and their devices with the FDA. If your device requires either a 510(K) or a PMA, you cannot commercially distribute the device until you receive a letter for substantial equivalence or approval from the FDA. Manufacturers are also required to comply with FDA’s Quality System Regulations/Good Manufacturing Practices (GMP) 21 CFR Part 820.
