When introducing a medical device to the Japanese market, the first thing to determine is its class classification. This classification is the starting point that dictates all regulatory responses, including the application route (approval, certification, or notification), required business licenses, scope of QMS application, and post-market safety management system. This article explains the definition of class classification under the Pharmaceutical and Medical Device Act (PMD Act), its correspondence with GHTF rules, and practical steps for determination, using specific examples faced by foreign manufacturers entering the Japanese market.
Table of Contents
- Basic Structure of Class Classification: 4 Tiers + Specified Maintenance Control
- Definitions of Each Class and Examples of Applicable Products
- Correspondence with GHTF Rules
- Procedure for Determining Class Classification
- Regulatory Requirements that Change with Class Classification
- Cases Where Determination Tends to Be Difficult
- Key Points for Foreign Manufacturers to Pay Special Attention To
- Summary
1. Basic Structure of Class Classification: 4 Tiers + Specified Maintenance Control
Medical devices in Japan are classified into four tiers based on the level of risk they pose to the human body. This classification is based on Articles 2, Paragraphs 5 to 7 of the PMD Act (Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices), and incorporates the framework of the GHTF (Global Harmonization Task Force, now IMDRF) from the perspective of international harmonization.
| Category | Class | Risk Level | Regulatory Category |
|---|---|---|---|
| General Medical Devices | Class I | Extremely Low | Notification |
| Controlled Medical Devices | Class II | Relatively Low | Certification or Approval |
| Specially Controlled Medical Devices | Class III | Relatively High | Approval |
| Specially Controlled Medical Devices | Class IV | Direct Threat to Life | Approval |
Separately from class classification, products requiring specialized knowledge and skills for maintenance and repair are designated as "Specified Maintenance Control Medical Devices". This designation is a category independent of the class, and even Class I general medical devices may fall under specified maintenance control.
2. Definitions of Each Class and Examples of Applicable Products
Class I (General Medical Devices)
Products that pose almost no risk of affecting human life and health even if side effects or functional impairments occur.
Examples: Medical tweezers, adhesive bandages, mercury sphygmomanometers, surgical needles, surgical tape, surgical lights, medical gauze, nebulizers, biopsy forceps for gastrointestinal endoscopy (single-use non-active endoscopic instruments for natural orifice access), etc.
Class II (Controlled Medical Devices)
Products that may affect human life and health if side effects or functional impairments occur, but can be managed with appropriate control.
Examples: Automatic electronic sphygmomanometers, home electric massagers, hearing aids, dental alloys, gastrointestinal endoscopes, X-ray CT diagnostic devices, electrocardiogram monitors, etc.
Class III (Specially Controlled Medical Devices)
Products that may have a significant impact on human life and health if side effects or functional impairments occur.
Examples: Dialysis machines, artificial bones, ventilators, radiation therapy devices, endoscopic treatment instruments (hemostatic clips, etc.), biliary stents and pancreatic stents, etc.
Class IV (Highest Risk Specially Controlled Medical Devices)
Products with a high degree of invasiveness to the patient, where malfunction may directly threaten life.
Examples: Pacemakers, artificial heart valves, coronary stents, cerebral vascular stents, implantable defibrillators, etc.
Specified Maintenance Control Medical Devices
Products designated as requiring specialized maintenance and control, independent of class classification.
Examples: Among Specially Controlled Medical Devices: Syringe infusion pumps, cardiopulmonary bypass systems. Among Controlled Medical Devices: Whole-body X-ray CT diagnostic devices, electrocardiogram monitors. Among General Medical Devices: X-ray television systems, surgical lights, etc.
3. Correspondence with GHTF Rules
Japan's class classification corresponds to the GHTF's four-tier classification (A, B, C, D).
| GHTF | Risk | Japanese Classification |
|---|---|---|
| Class A | Low Risk | Class I (General Medical Devices) |
| Class B | Medium-Low Risk | Class II (Controlled Medical Devices) |
| Class C | Medium-High Risk | Class III (Specially Controlled Medical Devices) |
| Class D | High Risk | Class IV (Specially Controlled Medical Devices) |
GHTF determination rules evaluate medical devices from the following four perspectives:
Presence or Absence of Invasiveness
Whether or not it invades the body. Invasive types are determined to be higher risk.
Route and Duration of Invasion
Risk varies depending on whether it's via body orifices or surgical, and whether it's temporary (less than 60 minutes), short-term (within 30 days), or long-term (more than 30 days).
Active or Non-Active Type
Active types using electrical or chemical energy are evaluated for risk based on the type and intensity of the energy source.
Special Purpose Devices
Integrated with pharmaceuticals, implantable, life support devices, etc., are subject to individual rules.
While EU MDR, US FDA, and China NMPA also generally follow the GHTF framework, there are country-specific differences in application and interpretation, so class classifications obtained overseas cannot be directly applied to Japan.
4. Procedure for Determining Class Classification
In practice, class classification is determined through the following steps:
Step 1: Identification of Generic Name (JMDN)
Search the "Generic Name of Medical Devices (JMDN)" database published by PMDA for a generic name corresponding to your product. Class classification is linked to each generic name.
Step 2: Confirmation of Similar Products
Search the PMDA's "List of Approved Medical Devices" for approved products similar to your product and confirm their class classification.
Step 3: Confirmation of Presence/Absence of Certification Standards
If it falls under Class II, confirm whether "certification standards" are stipulated for that generic name. If certification standards exist, it will be the certification route by a Registered Certification Body (RCB); if not, it will be the PMDA approval route.
Step 4: Determination of Applicability to Specified Maintenance Control
Evaluate whether the product requires specialized skills for maintenance and repair. If applicable, the requirements for sales business licenses, etc., will change.
Step 5: Confirmation through PMDA General Consultation for Medical Devices
If you are unsure about the determination or if it is an unprecedented product, it is recommended to officially confirm with PMDA's general consultation for medical devices. If an incorrect determination is made in the application, you may be asked to change the classification after the application is accepted, leading to significant delays.
5. Regulatory Requirements that Change with Class Classification
Class classification affects regulatory compliance throughout the product lifecycle.
| Item | Class I | Class II | Class III/IV |
|---|---|---|---|
| Pre-market Procedures | Notification | Certification or Approval | Approval |
| Marketing Authorization Holder License | Class 3 | Class 2 | Class 1 |
| QMS Application | Partial Application* | Full Application | Full Application |
| QMS Conformity Assessment | Not Required (except for some) | Required | Required |
| Manufacturer Registration/Foreign Manufacturer Registration | Required | Required | Required |
| Specially Controlled Medical Device Sales License | Not Required | Not Required | Required |
*Even for Class I, QMS applies to products including sterilization processes or specific items designated by the Ministry of Health, Labour and Welfare.
Furthermore, if designated as a Specified Maintenance Control Medical Device, regardless of its class, a sales and rental business license will be required.
6. Cases Where Determination Tends to Be Difficult
In practice, determination becomes complex in the following cases:
Products with Multiple Functions
For products with both diagnostic and therapeutic functions, the class is determined based on the higher-risk function.
Software as a Medical Device (SaMD)
If software alone qualifies as a medical device, it is classified according to its intended use and risk. There are specific determination criteria for SaMD, and it is necessary to check the latest version of PMDA's official guidance.
Combination Products
For combination products of pharmaceuticals and medical devices, the regulatory category itself changes depending on which has the primary function.
Treatment Instruments in the Gastrointestinal Endoscopy Field
Hemostatic clips, ESD knives, etc., may be classified as Class II or Class III depending on their structure. Note: Biopsy forceps for gastrointestinal endoscopy (single-use non-active endoscopic instruments for natural orifice access) are classified as Class I. and method of use, even if they appear similar. It is crucial to carefully confirm the approval information of similar products.
Highly Novel Products
There are cases where the GHTF rules cannot be mechanically applied. Obtaining an official opinion through PMDA's face-to-face consultation can help mitigate risks.
7. Key Points for Foreign Manufacturers to Pay Special Attention To
Inconsistency with EU MDR/FDA Classification
Classifications obtained overseas are not necessarily the same in Japan. For example, a product classified as Class IIa under EU MDR may be classified as Class III in Japan. Japan's class classification must be determined independently.
System Based on the Premise of JMDN
Japan's class classification is linked to Generic Name (JMDN) codes, and if a corresponding JMDN does not exist for your product, a new JMDN needs to be established. This is a procedure that can take more time than expected.
Overlooking Specified Maintenance Control Medical Devices
This is a unique Japanese system not found in overseas regulations. It directly impacts the requirements for sales business licenses, and overlooking it can significantly affect sales channel design.
Importance of Pre-confirmation of Class Classification
The selection of a DMAH (Designated Marketing Authorization Holder), preparation of business licenses, and design of the application route all start with class classification. Determining the class classification at an early stage of product development is key to optimizing the time and cost until market entry.
8. Summary
The following three points are crucial for accurately determining the class classification of medical devices:
- Start with JMDN and similar products: Identifying the generic name corresponding to your product and existing approved similar products is the basic step for determination.
- Do not directly apply overseas classifications: Since EU MDR/FDA classifications and Japanese classifications may not match, independent determination is necessary.
- Utilize PMDA face-to-face consultation if unsure: An incorrect determination can lead to significant delays after application, so obtain an official opinion in uncertain cases.
Class classification is the starting point for all regulatory compliance, not just the application route, but also business licenses, QMS, sales channels, and post-market safety management. Early and accurate determination streamlines all subsequent processes.
Need help with Japan's medical device approval?
Our regulatory affairs consultants specializing in digestive endoscopy devices provide end-to-end support from strategy to document preparation. Contact us for a free initial consultation.
Free Consultation