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Medical Device Registration in Japan-Todokede, Ninsho and Shonin Pathways

Let’s start with brief introduction about regulatory bodies

Minister of health, labour and welfare and PMDA: It is the main regulatory body which deals with drafting and implementing rules for the safety standards, manufacturing and approval process for the drug and medical devices. It also ensures the proper implementation of those rules at ground level.

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Pharmaceutical Medical Devices Agency (PMDA) is an independent entity which works along with Minister of health, labour and welfare (MHLW) and can be considered a technical arm for MHLW. PMDA keeps an eye on ADR (adverse drug reaction) and inspection of site and labs for proper compliance for GCP and GLP. PMDA works can be summarized in a single sentence: It is like FDA for JAPAN.

How Medical device is defined by the Japanese regulatory body

  • The definition of medical devices is stipulated in Article 2, Paragraph 4 of the Pharmaceutical and Medical Device Act as”
  • “Devices and equipment which are used for the purpose of diagnosis, treatment or prevention of diseases of human or animal, or affecting the structure or function of the human or animal body, and designated by the Enforcement Ordinance of the Pharmaceutical and Medical Device Act.”

Classification of Medical devices

Medical devices are classified based on the risk they impart on the body. There are four classes of Medical Devices and there are three pathways by which these devices can be approved. The approval process depends on the type of devices so first, let’s understand the type of the device.

Class I: They carry the least risk to human body in case any malfunction occurs. Let’s take an example of x ray films which are considered class I , just think what harm they can do to human body????

Class II (or controlled Medical Devices): it carries relative low risk (more than class I). MRI devices and Ultrasound devices etc.

Class III (Specially Controlled Medical Devices): The risk is high to human body if this type of devices malfunctions.

Class IV (Specially Controlled Medical Devices): Life threatening consequences can occur if this type of devices malfunctions. They are quite invasive in nature. Pacemaker and artificial heart valves are the good example for this type of devices

Approval Process-Three Pathways

1. Todokede (Notification): The applicant needs to file a notification to the PMDA. PMDA does not do any assessment. It is applicable for Class I medical devices.

2. Ninsho (certification by third party): In this process, third party provides the certificate to applicants for their Medical devices. This third party is accredited by MHLW. Many Class II devices follow this pathway.

3. Shonin (complete review and approval process): It is robust process for approval. PMDA checks the technical documents and thorough review process is required. Many Class III and all Class IV Medical devices follow this path.

Few Class III devices which have an associated certification standard (JIS), are subject to pre-market certification (Ninsho process)  Few class II devices without a Specific certification standard are subjected to follow Shonin pathway.

Is Clinical Data required?

New Medical Devices: A completely new devices need to establish its safety and efficacy in clinical trial for getting approved by PMDA.

Improved Medical Devices: A Improvement in already existing medical devices (between New and Generic).  Clinical Data may be required for approval.

Generic devices: Clinical Data is not required for approval.

Applicants must know about class (I, II, III, IV) and type (New, Improved, Generic) of Medical Devices prior seeking approval/certification/notification pathway. Japan does not accept CE labeling and/or certification from the FDA, whereas European and US approval helps speed up the review process

Market Authorization Holder

Company that gets a marketing authorization license is known as a market authorization holder (MAH). It should be noted that only registered MAH agency may import and sell medical products to the Japanese market. So it becomes compulsion for all foreign manufacturers to  designate a MAH or Designated Marketing Authorization Holder (DMAH) to manage their product registrations in Japan.

The Pharmaceuticals and Medical Devices Act (PMD Act)

It came into effect on  November 25, 2014 and replaces the Pharmaceutical Affairs Law (PAL). Key points:

  • Some Class III medical devices can be approved by  third party certification (Ninsho)
  • regulation of medical software
  • , Manufacturers are required to be registered rather than be licensed.
  • Quality management systems (QMS) are streamlined.
  • Manufacturers must comply with the new PMD Act to sell medical devices in Japan.
  • Ref: https://www.regdesk.co/an-overview-of-medical-device-regulations-in-japan/ https://www.emergobyul.com/services/japan/pmda-medical-device-registration-approval-process

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