Navigating Japan’s Regulatory Landscape for Medical Devices

Across the world, Japan is known for its technological innovations. It is also one of the largest markets for healthcare and medical devices. Overall, the Japanese medical device market is stringently regulated and the enforced regulations ensure safety and effectiveness of the medical devices. The regulations also promote innovation across the devices.

The major requirements and regulations enforced on the Japanese medical device landscape stem from the Ministry of Health, Labor, and Welfare (MHLW). Another agency involved in enacting these regulations is the Pharmaceuticals and Medical Devices Agency (PMDA).

The Pharmaceutical and Medical Devices Law (PMD) Act

This law governs some of the major areas of Japanese medical device market. It also performs reviews on new drugs, quasi-drugs, and Behind-the-Counter (BTC) drugs. PMDA also re-evaluates the previously approved drugs.

Delving into Major Medical Requirements Concerned with Medical Devices

Classification of Medical Devices

Medical devices are classified into four categories. This categorization has been done according to the dangers/risks posed by each class. Devices included in Class I pose the least danger, while Class IV devices carry the most risk to the human body.

A brief overview of these classes is given as follows:

  • Class I Medical Devices (Extremely low risk): General Medical Devices, such as X-ray films.
  • Class II Medical Devices (Low risk): These are Controlled Medical Devices, such as digestive catheters and MRI machines.
  • Class III Medical Devices (Medium risk): These include Specially Controlled Medical Devices, such as dialyzers and artificial bones, etc.
  • Class IV Medical Devices (High risk): These are also Specially Controlled Medical Devices but pose a greater risk to the human body. Examples include artificial valves and cardiac pacemakers. 

Requirements for Foreign Manufacturers

Foreign manufacturers who want to market their medical devices in Japan must obtain a certification or submit a notification according to the class of medical device they wish to import. This must be done while pursuing the PMD Act via a

  • Japanese Marketing Authorization Holder (MAH) or
  • A Japanese manufacturer appointed by the said foreign manufacturer.

Here, it is pertinent to mention that:

  • General Medical Devices (Class I) require only a self-declaration/notification to PMDA.
  • Controlled Medical Devices (Class II): These devices can be further divided as follows:
  • Those devices for whom certification standards exist must get their certification by a registered body, and
  • The rest of Class II devices must receive approval from MHLW
  • Specially Controlled Medical Devices (Class III): Classes belong to these devices have the same requirements as devices belonging to Class II devices.
  • Specially Controlled Medical Devices (Class IV): These devices must get approval of MHLW.

Also, the MAH must ensure devices’ efficacy, quality, and safety on the basis of evidence presented before submission. This must be done regardless of the device’s class.

PMDA and Regulatory Approval for Regenerative Medical Products

Under PMDA, cellular and tissue-based regenerative products are defined as processed human tissues and cells. These regenerative products are intended to be used for:

  • Gene therapy
  • Treatment and prevention of diseases, and
  • Reconstruction, structure formation, or repairing existing structures inside the human body

Useful URL Resources for Medical Device Manufacturers and Importers

Here, we are mentioning some of the valuable URLs that contain important resources for medical device manufacturers and importers willing to work in the Japanese regulatory environment for medical devices.

  • Devices requiring Certification by registered certification body: Such products must get certified by a Registered Certification Body. A list of Registered Certification Bodies is given in the embedded link (available in Japanese only).
  • Devices Requiring MHLW Approval: For these devices, PMDA must certify scientific evidences in the review. For individual products. The regulatory requirements are assessed on case-by-case basis and responded to in PMDA’s consultations. For further information, you can visit the following links (available in Japanese only): Page 1 & Page 2.
  • Consultation Service on R&D or Regulatory Submission: These consultations require a consultation fee. However, what matters will be discussed in these consultations can be clarified in a pre-consultation meeting with no charges. The PMDA’s annual report has all charges listed, but they can be changed without prior notice. They also provide the scope of approval of medical devices and rules of evaluation criteria for medical devices.

Types of Application Processes and Licenses                             

The four main types of licenses and applications concerned with the Japanese medical device regulatory market are as follows:

  1. Manufacturing License: A manufacturing license permits medical device design, manufacture, sterilization, and end-product storage (including labeling, packing, and package insert management), etc. Standards outlined in the QMS Ordinance, which provides quality control requirements for production and sales operations, must be followed by manufacturers.

Manufacturers are only allowed to promote and distribute medical devices to Marketing Authorization Holders; they are not allowed to sell medical devices directly to medical institutions.

  • Marketing Authorization Holders License: MAH provides regulatory applications, pharmaceutical applications, import authorization, compliance with regulatory laws, and sales channel management across the medical device import-to-market process. The medical device’s classification also dictates the extent of its responsibilities. Manufacturers sell medical devices to MAH and retail/rental license holders because they are not allowed to market directly to medical institutions.
  • Rental service/ Retail License: Medical facilities or other retail and rental service license holders may purchase medical devices from companies having retail and rental service licenses. Depending on the classification of medical devices, the organization may also require certification for highly advanced controlled medical devices or the status of notification for controlled medical devices.
  • Repairs License: The scope of repairs under this license is determined by two categories: specially controlled and non-controlled.

There are various product classifications in each of these categories, and organizations must possess the permits required for the particular product classification they handle. These were some of the major aspects concerning the regulatory environment in Japan surrounding medical devices, their manufacturing, and marketing. If you want to know more, then you can use consultancy services on regulatory environment in Japan and other jurisdictions across the globe.

About the Author

Waqas Imam

S. M. Waqas Imam is associated with TS Quality as a Regional Partner. He is also an ambassador of Medical Device Community. He is an Industrial Engineer by qualification and served the manufacturing industry since 2011. He is also IRCA CQI Lead Auditor of ISO 9001 and other management system standards. He had served as Quality Assurance and Regulatory Affairs Manager in QSA Surgical Pvt. Ltd. and Ultimate Medical Products. He managed requirements of ISO 13485:2003, EU directives, CE marking and FDA. He also served as Expert Blog Writer for 13485Academy and wrote expert articles on various topics of ISO 13485:2016.