Regulation, review, and authorization are critical tools for bringing medical devices to market, monitoring patient safety, and ensuring the best health outcomes. While regulatory guidance can vary globally, comparing approval processes can help open the reliability of each pathway. The Food and Drug Administration (FDA) is responsible for evaluating and regulating medicines in the United States. Similarly, the European Medicines Agency (EMA), Medical Devices Directorate (MDD), and Pharmaceuticals and Medical Devices Agency (PMDA) regulate medical devices across the European Union, Canada, and Japan.
Medical Device Classifications in the US
In the United States, medical devices are classified under three categories:
Class I General Controls
Class II General Controls and Special Controls
Class III General Controls and Premarket Approval
Class I medical devices pose the lowest risks, whereas class III medical devices pose the highest risks. The FDA states that “device classification depends on the intended use of the device and also upon indications for use.” There are various methods of determining the classification of a device, each of which requires knowledge of the regulation number.
Accessing the regulation number of your device can be done through the Product Classification Database. Once obtained, selecting on the corresponding regulation number listed on the Device Classification Panels page will guide you to the device classification. Additionally, the FDA can fulfill 513(g) Requests for official device classifications.
Marketing Clearance in the US
The FDA requires a Premarket Notification (PMN), also known as a 510(k), to be filed before a medical device is permitted to be marketed in the United States. A ruling of “substantially equivalent” must be issued by the FDA prior to any marketing.
The FDA may approve of an Investigational Device Exemption (IDE) to authorize the testing of the medical device in clinical studies, as overseen by representatives from Institutional Review Boards (IRB), who are present to ensure patient safety. Beneficial evidence obtained through such clinical studies can boost device applications for Premarket Approval (PMA).
As novel medical devices are without any preceding devices to compare, unconventional products are automatically designated under Class III. The De Novo Classification poses a unique option for relatively low-risk medical devices with qualities that would typically align with the tier of Class I or Class II. The FDA relies on the De Novo Classification to “provide reasonable assurance of safety and effectiveness for the intended use, but for which there is no legally marketed predicate device.” It is recommended that inquiring companies first file a Pre-Submission before sending an official De Novo Request either through the CDRH Portal online or by mail.
Medical Device Classifications in the EU
Medical device classifications in the EU differ from those in the United States with the division of Class II into Class IIa and Class IIb, along with slight differences in the criteria for classifications. Both Class IIa and Class IIb cover devices with moderate risk and specific controls, with the former pertaining to products that are naturally invasive and not hazardous (e.g., hearing aids). Class IIb devices tend to be surgically invasive and implantable in the body (e.g., ventilators).
Burden of Proof
Devices must demonstrate effectiveness
Devices must “function as intended”
Manufacturer interact with single federal entity throughout process
Numerous (>70) Private groups (Notified Bodies) compete in open market for opportunity to approve devices
Available within US
Approval by one NB allows marketability in each member country
Time of Approval
3-11 months for 5100(k), 9-54 months for PMA
For 5100(k) and PMA equivalents, 4 and 11 months, respectively
Marketing Clearance in the EU
The European Medicines Agency (EMA) is the European counterpart to the American FDA. A medical device must pass the EMA’s conformity assessment prior to receiving a CE (Conformité Européenne) mark.
The European Union evaluates and regulates medical devices through a branch of the National Institute for Health and Clinical Excellence (NICE), the Medical Technology Evaluation Programme (MTEP). A CE mark from the European Medicines Agency (EMA) is required, or the guarantee that the mark will be given within a year.
Companies must file a Marketing Authorisation Application (MAA), which grants approval to all states in the EU and European Economic Area-European Free Trade Association, once the device is greenlit by the European Commission.
Medical Device Classifications in Canada
Canada’s medical device classification consists of Class I, Class II, Class III, and Class IV. Class II, III, and Class IV products must have a medical device license prior to being sold in the nation.
Marketing Clearance in Canada
In Canada, the Medical Devices Directorate (MDD) “monitors and evaluates the safety, effectiveness and quality of diagnostic and therapeutic medical devices in Canada.”
A Medical Device Establishment Licence (MDEL) must be obtained to manufacture or sell products in Canada.
Marketing a Class II device in Canada requires the MDD’s approval of a medical device license amendment application form for Health Canada. If the product is in compliance with Canada’s Medical Devices Regulations, the MDD will issue the license to market in Canada. On average, the MDD will review and return applications for Class II devices Class within 15 calendar days of submission.
Medical Device Classifications in Japan
There are four classifications of medical devices in Japan: Class I, Class II, Class III, and Class IV. Class II devices are controlled and relatively low risk (e.g., MRI equipment).
Table 2: Classification of medical devices in Japan with examples
I: General medical device
II: Controlled medical device
Relatively low risk
Endoscopy, dental alloying agents, ultrasound equipment, MRI units
III: Specially controlled medical device
Dialyzer, artificial bone graft
IV: Specially controlled medical device
Invasive, potentially life-threatening
Stent, pacemaker, artificial heart valve
Class II Marketing Clearance in Japan
A valuable insight from the Johner Institute: All documents submitted during the authorization procedure must be in Japanese.
The documentation for a device having met the Japanese Quality Management System (JQMS) medical device requirements is the ISO-13485 certificate. Additionally, a Marketing Authorization Holder (MAH) or Designated Marketing Authorization Holder (D-MAH) must be appointed. Other roles must be assigned, such as domestic warehouse manufacture and those in charge of transport, sales and repairs.
Submitting a Form 63-5 for the Ministry of Health, Labour and Welfare (MHLW) is necessary to be officially registered as a foreign manufacturer.
For Class II devices, a pre-market certificate must be issued by the Registered Certification Bodies (RCB). Pre-market approval (PMA) is also required, and must be authorized by the PMDA.
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Operations Specialist & Healthcare/Pharma Compliance Expert
Charlene is responsible for overseeing agency staffing, supervising the company’s daily operations, managing relationships with key vendors, and more. With over a decade of helping companies with traditional and unique requests, Charlene has been able to bring staff, tools, and project plans together in order to ensure every detail is addressed and accounted for. No matter what you need, Mind Machine is equipped to get you across the finish line.