Japan stands as the world’s second-biggest medical device market, after the US. The Japanese medical device market is expected to reach from $54.5 billion in 2018 to $74.7 billion in 2025, growing at a compound annual growth rate (CAGR) of 4.6% according to GlobalData, The MHLW has taken several steps to improve the process for medical device market approval in Japan.
Top reasons to choose Japan as your medical device market
- The rapidly aging Japanese population,
- An increasing number of patients with chronic and lifestyle diseases,
- Universal health insurance coverage, and
- Regulatory measures are assumed to drive the Japanese medical device market.
The Japanese government has taken new initiatives to streamline the regulatory approval review process and accelerate the launch of innovative medical products.
The Ministry of Health, Labor, and Welfare (MHLW) has taken several steps and made to improve the transparency of the approval review system to accomplish a quick review process, which is equivalent to, or faster than that of North American and European markets.
Regulatory authority for medical devices in Japan
The Ministry of Health, Labor, and Welfare (MHLW) is Japan’s primary regulatory body for creating and implementing safety standards for medical devices and drugs and within the MHLW. The Pharmaceutical and Food Safety Bureau is in charge of pharmaceutical and medical device regulatory policy.
Pharmaceutical Medical Devices Agency (PMDA) is an independent administrative agency that works with the MHLW to ensure the safety and quality of drugs and medical devices in Japan and is the technical arm of the MHLW.
The Pharmaceutical Medical Devices Agency (PMDA) handles
- Approval review of medical devices,
- QMS/GLP/GCP inspection, and
- Collection and analysis of Adverse Event Reports.
Medical Devices are required to undergo regulatory approval based on the Pharmaceuticals and Medical Devices Law (PMDL) in order to enter the Japanese market.
The process to register your medical device in Japan
The process to register the medical device in Japan follows some unique steps. The regulatory process and timeline vary based on the class to which your medical device belongs.
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How can foreign manufacturer market their medical device in Japan?
Foreign companies who intend to manufacture drugs, quasi-drugs, active pharmaceutical ingredients (APIs), or medical devices overseas and import them into Japan must be registered with the Ministry of Health, Labor and Welfare (MHLW).
- This process is known as Toroku, or Foreign Manufacturer Registration (FMR).
- It is a separate process from the product registration process and is required for obtaining product registration approval.
Requirements & approval process for medical devices by the PMDA in Japan
Based on the category & class to which the medical device belongs, the requirements, regulatory, and process flow varies. So let’s discuss each class of medical devices one by one.
Medical devices classification
- Class I Devices: General Medical Devices
- The risk to patients in the event of a malfunction is regarded as almost negligible (e.g. s-ray Film).
- Class II Devices: Controlled Medical Devices
- The risk to patients in the event of a malfunction is regarded as relatively low (e.g. MRI, digestive catheters).
- Class III Devices: Specially Controlled Medical Devices
- The risk to patients in the event of a malfunction is regarded as relatively high (e.g. artificial bones, dialyzer).
- Class IV Devices: Specially Controlled Medical Devices
- The device is highly invasive with potential fatal risks to patients (e.g. pacemaker, artificial heart valves).
Regulatory for Class I Devices
The approval process of Class I Devices is called Todokede.
Some of the requirements for the approval of class I medical devices include category, name (generic/proprietary), intended use, shape, structure, etc.
The approval process starts with filing a notification by the MAH, and usually, this category of the medical device may not require assessment by the PMDA.
The Quality Management System (QMS) system shall be applied and need to comply with the PMD Act and the Ministry of Health, Labour, and Welfare (MHLW). However, manufacturing facilities need to be registered.
Regulatory for Class II Devices
The approval process of Class II Devices is called Ninsho.
The required documents for registration of class II medical device include details about intended use, proprietary name, shape, structure, direction for use, manufacturing methods, storage conditions, and shelf life, etc.
- The MAH needs to initiate the application with a notarized body. Certain class II devices may require both reviews by PMDA and MHLW.
- The foreign manufacturer may require an extra layer of approval.
- This class of medical devices also requires maintaining the Quality Management System (QMS).
The timelines depend on the completeness of the application and other factors and may vary from 4 to 9 months.
Regulatory for Class III & Class IV Devices
The approval process of Class III and Class IV Devices is called as Shonin
- The application for Class III & Class IV is almost the same with few differences. This process also applies to Class II Controlled medical devices.
- The application is made with the PMDA.
- The PMDA conducts a QMS conformity assessment inspection at the manufacturing site.
The requirements for the application include general requirements, such as medical device category, intended use, efficacy risk analysis data, clinical data, etc. Along with this, the attachments such a summary of technical documentation (STED).
The timelines for approval vary based on the class to which the device belongs and the type of application approval process.
Various application categories for Medical Devices
- New medical devices (require clinical trial data required)
- Improved medical devices (require clinical trial data)
- Improved medical devices (does not require clinical trial data)
- Me-too medical devices (doesn’t require clinical trial data)
- Me-too medical devices (doesn’t require clinical trial data and compliant with approval standards)
Japan Medical Device Nomenclature (JMDN codes)
- A database of generic medical device descriptions with associated Japan Medical Device Nomenclature (JMDN) codes is maintained by MHLW.
- JMDN system is similar to the Global Medical Device Nomenclature (GMDN) system or the US FDA system.
- If the medical device code does not exist in this database, then products must undergo a new registration pathway based on the class to which it belongs.
Medical device registration, expiration, and renewal
- Medical device registration doesn’t expire, however, Quality Management System (QMS) certificates shall be renewed every 5 years, and should be processed 6 months prior to expiration.
- Pre-Market Certification applications may also be subject to annual surveillance audits.
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