Japan has one of the largest and most technologically advanced medical device markets in the world. As a result, it is crucial for manufacturers to understand Japanese medical device standards to ensure their products comply with regulations and can be sold in the country. This blog post will provide a comprehensive overview of the regulations and standards for medical devices in Japan and offer guidance on how to ensure compliance.
Japanese Regulatory Authorities and Framework
The country has different sectors that are responsible for regulating medical device safety and effectiveness.
Ministry of Health, Labour and Welfare
This is the central government agency responsible for implementing policies related to healthcare, including medical device regulation. The MHLW sets standards for medical devices and enforces compliance through its regulatory arm, the PMDA.
Pharmaceuticals and Medical Devices Agency (PMDA)
The PMDA is the primary authority that is responsible for overseeing the medical device sector in Japan. The PMDA ensures that devices entering the market are safe and effective by conducting pre-market evaluations, reviewing post-market data, and monitoring manufacturers for compliance with regulatory requirements.
Japanese Pharmaceutical Affairs Law (JPAL)
The Japanese JPAL is the main legislation. It is the main legislation governing the manufacture, sale, and distribution of medical devices in Japan. The JPAL establishes the legal framework for Japanese medical device compliance, outlining the various requirements manufacturers must meet to ensure their products can be legally marketed in the country.
Key Japanese Regulations for Medical Devices
Japanese Industrial Standards
JIS is a series of nationally recognized standards that outline the minimum requirements for a wide range of products, including medical devices. Some of the key JIS related to medical devices are:
- JIS T 0601: Medical Electrical Equipment – Provides specifications for the safety and performance of medical electrical equipment, including diagnostic, monitoring, and therapeutic devices.
- JIS T 1001: Medical Equipment – General Requirements – Outlines the general requirements for medical equipment, such as materials, construction, and labeling.
- JIS T 1002: Medical Equipment – Particular Requirements – JIS T 1002 contains specific requirements for various types of medical equipment, including devices for anesthesia, respiratory therapy, and patient monitoring.
Quality Management System (QMS)
Essential for ensuring the consistent quality and safety of medical devices. There are two key QMS standards that apply to medical device manufacturers:
Ordinance No. 169: QMS Requirements For Medical Device Manufacturers
Ordinance No. 169 establishes the QMS requirements for medical device manufacturers in Japan. It sets out the framework for a manufacturer’s quality management system, including requirements for documentation, design and development, production, and post-market surveillance.
JIS Q 13485: Japanese Adaptation of ISO 13485
This is the Japanese adaptation of ISO 13485, an internationally recognized standard for medical device QMS. It provides guidance on establishing, implementing, and maintaining a QMS for medical device manufacturers in Japan.
Medical Device Nomenclature System
The medical device nomenclature system (MDNS) is a standardized classification system used to identify and categorize medical devices. In Japan, these are the main MDNS:
Global Medical Device Nomenclature
The GMDN is an internationally recognized system used to classify and identify medical devices. It provides a standardized approach to device classification, enabling consistent communication between manufacturers, regulators, and healthcare providers.
Japanese Medical Device Nomenclature
A Japan-specific medical device nomenclature system that complements the GMDN. It is used for classifying and identifying medical devices in Japan and is recognized by the PMDA and MHLW. Manufacturers seeking to market their products in Japan must ensure that their devices are correctly classified according to the JMDN.
Biological Evaluation of Medical Devices
JIS T 0993 is the Japanese adaptation of ISO 10993, an international standard for the biological evaluation of medical devices. This standard outlines the requirements for assessing the biocompatibility of medical devices, including testing for cytotoxicity, sensitization, and irritation.
Pre-Market Requirements
These requirements are vital for gaining regulatory approval from the PMDA to market medical devices in the country.
Device Classification
Medical devices are classified into four categories based on their risk level:
- Class I: General Medical Devices – These devices pose the lowest risk and include items such as bandages and surgical gloves.
- Class II: Controlled Medical Devices – Class II devices have a moderate level of risk and consist of products like infusion pumps and diagnostic imaging equipment.
- Class III: Specially Controlled Medical Devices – They pose a moderate to high level of risk and involve products such as implantable pacemakers and artificial joints.
- Class IV: Highly controlled – They pose the highest level of risk and involve products such as neuro catheters and heart transplant devices.
Registration and Approval Process
Manufacturers must submit a pre-market application to a Registered Certification Body (RCB) or the PMDA for review and approval. Generally, RCBs regulate less risky medical devices, and the PMDA regulates more risky medical devices. This application includes information about the device’s design, materials, manufacturing process, and clinical data demonstrating its safety and efficacy.
The RCB or PMDA reviews the pre-market application to ensure the device meets the appropriate Japanese medical device standards. If the device is found to be safe and effective, the RCB or PMDA will grant approval, allowing the manufacturer to market the product in Japan.
Post-Market Requirements
Adverse Event Reporting
Manufacturers and local Marketing Authorization Holders (MAHs) must monitor the safety and performance of their devices after they enter the market and report any adverse events to the PMDA.
- Reporting Criteria – Adverse events that must be reported include device malfunctions, use errors, and incidents that result in patient injury or death.
- Reporting Timelines – Manufacturers must report adverse events within specified timeframes, depending on the severity of the incident.
Quality System Audits
Device manufacturers will sometimes undergo regular quality system audits by the PMDA to ensure ongoing compliance with Japanese medical device standards. Manufacturers should also renew their QMS certification every 5 years to maintain their ability to market their devices in Japan.
Ensuring Compliance with Japanese Standards
Working with local regulatory consultants and experts can help manufacturers navigate the complex regulatory landscape in Japan and ensure compliance with Japanese medical device regulatory requirements and standards.
Conducting regular internal audits and providing training for employees can help identify potential areas of non-compliance and ensure that the organization maintains its commitment to Japanese medical device compliance. Building a relationship with the PMDA or an RCB can provide valuable guidance and support in maintaining compliance with Japanese standards for medical devices.
Understanding and complying with regulatory requirements and standards for medical devices in Japan is essential for successfully entering and maintaining a presence in the Japanese market. By familiarizing themselves with the key standards, working with local experts, and implementing robust quality management systems, manufacturers can ensure their products meet the stringent requirements set by the PMDA.
By doing so, they not only safeguard their market access in Japan but also contribute to the overall safety and effectiveness of medical devices used by healthcare providers and Japanese patients alike. By taking these steps, manufacturers can confidently navigate the Japanese regulatory landscape and establish a strong foothold in one of the world’s most advanced medical device markets.
