Written by Dominique Engome Tchupo, Ph.D.
Senior Human Factors Researcher
Jumpseat Research
Overview of Medical Device Regulation and Why it Matters to You
Medical device regulation is important for patient health and safety. Regulation ensures that medical devices are not misbranded and assures their safety and effectiveness for their intended use. From the perspective of medical device developers and healthcare organizations, the regulatory clearance process presents several challenges, and the cost of doing it wrong can quickly eat into the margin or tank the company completely. A thorough understanding of the different regulatory hurdles you may face is critical to planning a successful product launch onto the market.
Regulation varies by country and/or economic region; therefore, several regulatory bodies exist to govern the distribution and safety of medical devices globally. When developing a medical device, it is important to know where one plans to market it and keep up with the regulatory requirements of that country or region.
Regulatory Compliance in the US
The Primary Regulatory Authority
Regulatory compliance of medical devices in the US is overseen by the Food and Drugs Administration (FDA). More specifically by the FDA’s Center for Devices and Radiological Health (CDRH) which handles regulating firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States. The CDRH was created by merging different units that regulated medical devices and acts as a centralized authority for their approval in the US.
Approval Procedures
The FDA classifies medical devices into 3 categories; Class I, Class II, and Class III, with control increasing as the class number increases. While most devices in Class I are exempt from the Premarket Notification 510(k) (a simplified version of the FDA’s approval process for selling a new device), most devices in Class II require Premarket Notification 510(k) and most devices in Class III require Premarket Approval (PMA). In other words, Class I devices do not typically need to undergo an audit prior to going on the market while Class II and Class III devices typically do.
The main difference in the pre-market approval process between 510(k) and PMA is that the 510(k) is used to market medium-risk devices when there is already a similar device, known as a predicate, on the market, and PMA is used to market high-risk and novel devices. In practice this means that medical devices eligible for the 510(k) have different experimental trial requirements than those medical devices needed to undergo the PMA. This also leads to different time expectations for the process, with PMA typically longer, up to 36 months (about 3 years), than 510(k) at up to 9 months.
Regulatory Compliance in the EU
The Primary Regulatory Authority
Regulatory compliance of medical devices in the European Union is largely under the control of the Medical Device Regulation (MDR) which went into effect in 2021. Unlike the US with a centralized body (the CDRH) tasked with regulating medical devices, the EU’s MDR is a framework with assigned Notified Bodies responsible for the approval of medical devices and their post-market monitoring.
Approval Procedures
According to the MDR, medical devices can fall into Class I, Class II (IIa and IIb), and Class III, with increasing risk as the class number increases. The MDR separates Class II devices into non-implantable (Class IIa) and implantable (Class IIb) devices. Both the FDA and MDR do not require Class I devices to undergo an audit prior to being put on the market. However, unlike the US, Class IIb and Class III devices have the same requirements for clinical data in the EU.
For Class II and Class III devices that require approval, the medical device manufacturer needs to prepare the Technical Documentation, a comprehensive review of your device showing compliance with the EU regulations. Documentation review occurs in 5 steps which take about 12 months in total.
Regulatory Compliance in Japan
The Primary Regulatory Authority
Regulatory compliance of medical devices in Japan is controlled by two regulatory authorities, the Ministry of Health, Labor, and Welfare (MHLW), and the Pharmaceuticals and Medical Devices Agency (PMDA). The MHLW is tasked with the administrative portion of regulation, while the PMDA is tasked with product review and post-market safety measures. Devices marketed in Japan must comply with the Japan’s Pharmaceutical and Medical Devices Act (PMD Act). Few of Japan’s regulatory documents are published in any language but Japanese, making it challenging for foreign manufacturers to comply with Japan’s PMD Act.
Approval Procedures
Japan’s medical classification system is divided into 4 classes, I (extremely low risk), II (low risk), III (medium risk), and IV (high risk). Class I medical devices only require notification to the PMDA, Class II and Class III medical devices are divided according to whether they have existing certification standards or not. If certification standards exist, certification by the registered certification body is required, but for those without certification standards, approval of the MLHW is required prior to marketing the medical devices in Japan. Many Japan Industrial Standards are based off ISO/IEC standards (more on ISO/IEC in a later article). Class IV medical devices also require MLHW approval. An additional requirement is for the foreign manufacturer to appoint an in-country representative, the Marketing Authorization Holder (MAH). Regardless of class, the MAH needs to confirm the safety, efficacy, and quality of the device.
Regulatory Compliance in India
The Primary Regulatory Authority
Regulatory compliance of medical devices in India is regulated by the Central Drugs Standard Control Organization (CDSCO). The CDSCO is under the Directorate General of Health Services in the Ministry of Health & Family Welfare. The most recent legislation governing the regulation of medical devices is the Medical Devices (Amendment) Rules of 2020, which is an amendment of the Medical Devices Rules of 2017. The CDSCO handles issuing importation licenses for medical devices manufactured and licensed in other countries.
Approval Procedures
Medical devices are separated into 5 product categories based on risk level. These categories are Class A (Non-Measuring/Sterile), Class A (Measuring/Sterile), Class B, Class C, and Class D. Class A (Non-Measuring/Sterile) products only require being registered through an online portal and importation can begin almost at once. All other device classes need further approval which can take 6 to 9 months, with novel or innovative products, without a predicate, often taking longer.
Import registration for Class A (Measuring/Sterile), Class B, Class C, and Class D medical devices requires submitting a Device Master File (DMF) detailing the product and a Plant Master File (PMF) detailing the manufacturing facility. The DMF is mainly a reassessment of the product’s existing approval which includes submitting the same documentation and evidence as in the reference country, with special attention paid to the predicate choice. The PMF requires ISO 13485 certification to certify the quality systems and/or actual manufacturing facilities (more on ISO standards in an upcoming article). A PMF needs to be submitted for each manufacturing site. Therefore, manufacturers with multiple sites will be issued an Import License for each site.
Medical Device Regulation Outlook
Medical device regulation varies by location, with the various bodies in charge having different rules. It is therefore of utmost importance to identify the desired market to ensure conformity with the target location’s requirements. This prevents late-stage issues from occurring or worse, not being able to sell your product after spending months or years on expensive regulatory testing.
In addition to the regulatory bodies of the various regions, there are overarching governing bodies that provide guidance for the manufacture and design of medical devices. These bodies do not have the authority to approve or deny marketing, however, many of the regulatory bodies require their certification as part of the approval process (more to come on these bodies and why they matter in an upcoming article). Due to the many nuances of the medical device regulation process, it is imperative that manufacturers work with people familiar with the process in their target market(s).