Gain market access in Japan

Pharmaceutical and Medical Device Act (PMD Act) Regulation

The distribution of medical devices in Japan is regulated in accordance with the Pharmaceutical and Medical Device Act (PMD Act) Regulation by the Ministry of Health, Labour and Welfare (MHLW).  The former Regulation, Japanese Pharmaceutical Affairs Law (JPAL) was replaced by PMD Act on November, 25, 2014. The revision includes third party certification systems for Class III medical devices and expansion of the responsibility of quality management system to legal manufactures.

Because of the complexities of PMD Act and the involvement of Japanese and international governmental bodies, we have developed resources to explain device classification, the review process and the required standards.

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What has changed from JPAL to PMD Act?

The current license/accreditation will stay in force until they expire at the end of date of certificate.

  • Marketing Authorization Holder (MAH – the Legal manufacturer in Japan) will be responsible for QMS and Good Vigilance Practice (GVP)
  • All Class II devices’ design control activities will be covered in the quality management system audit (Article 30-36, 7.3)
  • Standalone Software becomes a Class II Device
  • Some Class III devices will move to the certification scheme of the 3rd party certification body
  • Manufactures will be requested to “be registered”

Pharmaceutical and Medical Devices Agency (PMDA) review process

Under PMD Act, the Pharmaceutical and Medical Devices Agency (PMDA) review process depends on the classification of the medical device, which is generally in line with the principles outlined by the International Medical Device Regulators Forum:

Class I General Medical Devices: Pre-Market Submission (Todokede)

  • Devices of low risk to the human body
  • Approval of the product is not required, but marketing notification (Todokede) to PMDA is necessary

Class II and Class III (partially) Controlled Medical Devices: Pre-Market Certification (Ninsho)

  • Low risk to the human body
  • The majority of these devices for which certification standards have been established by MHLW, are eligible for third-party review and certification by a Registered Certification Body, such as BSI. Those devices for which no applicable certification standard has been established must be submitted to PMDA for approval (Shonin) by MHLW

Class III and IV Specially Controlled Medical Devices: Pre-Market Approval (Shonin)

  • Medium risk to human body, high risk to human body, highly invasive to patients
  • MHLW approval (shonin) is required for Class III and IV devices, based on approval standards for devices for which such standards have been established, or based on  review guidelines

Japan and the Medical Device Single Audit Program

The The Medical Device Single Audit Program (MDSAP) allows manufacturers to undergo a single audit to meet the QMS/GMP requirements of multiple Regulatory Authorities (RAs).

The Ministry of Health, Labour and Welfare (MHLW) and the Pharmaceutical and Medical Devices Agency (PMDA) will utilize these audit reports in both pre-market and periodical post-market audit under regulations in Japan. 

MDSAP Audits are conducted by Auditing Organizations (AO), such as BSI, which are authorized by the participating RA to audit under MDSAP requirements. MDSAP is a way that medical device manufacturers can be audited once for compliance with the standard and regulatory requirements of up to five different medical device markets: Australia, Brazil, Canada, Japan and the United States.

A BSI MDSAP audit can also be combined with assessment for CE and ISO 13485.

What is BSI's role in market access in Japan?

We are one of four Registered Certification Bodies (RCB) that is authorized to conduct certifications by the MHLW for all types of Class II Designate Controlled Medical Devices and In-Vitro Diagnostic Reagents. We also provide a number of solutions for our global customers wishing to access the Japanese market, including MDSAP auditing as a recognized Auditing Organization (AO). So as your company grows and expands sales into overseas markets, we can support your regulatory needs, allowing you to meet the increasingly complex regulatory schemes and certifications.

Streamlined audits can help save you money

We have auditors qualified to conduct MO 169 audits in Asia, Europe and the Americas, and can combine the required PMD Act audits with our clients’ ISO 13485 and Notified Body audits, streamlining the process. And to save you from additional audits, our reports covering ISO 13485 and MO 169 are accepted by other RCBs for use in conjunction with their reviews of product submissions from their Market Authorization Holder (MAHs).

Supporting smaller companies with global market access

Newly established or smaller companies may have a challenge obtaining a Japan-based Market Authorization Holder (MAH) with QMS & GVP capability to hold the marketing approval. Japan has harmonized the QMS requirements with ISO 13485, but there are additional requirements that will fall under the responsibility of overseas manufacturers under Ministerial Ordinances’ requirements for accreditation. With experience working with companies of all sizes, we have the expertise to support you as you break into this highly regulated yet profitable overseas market.

Our core competencies and unique skills are calibrated to handle our customer’s extensive portfolio of medical technologies.