Approval of Medical Devices in Japan

Insights into a Successful Market Entry in Japan

Japan is the second-largest market for medical devices globally, offering significant potential for manufacturers. However, securing product approval in Japan is particularly challenging due to language barriers and a complex regulatory framework. This process includes appointing a Market Authorization Holder (MAH), registering manufacturing sites, and complying with Ministry of Health, Labour and Welfare (MHLW) Ordinance No. 169. Notably, the complexity of the approval process varies depending on the risk class of the medical device.

The regulatory framework for medical devices is defined by the Pharmaceutical and Medical Devices Act (PMD Act), commonly referred to as the PMD Law, which was amended in 2014, along with various control provisions.

Find out here which requirements apply to your medical device in Japan and how to fulfill them.

General information

Japanese authorities responsible for the market access of medical devices include the Ministry of Health, Labour and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA).

The PMDA is specifically responsible for the regulation of pharmaceuticals and medical devices, playing a crucial role in evaluating safety and effectiveness, as well as in approving new products for the Japanese market.

Effective cooperation between the MHLW and the PMDA is essential for ensuring a smooth and efficient market entry for medical devices in Japan. The MHLW manages the overall regulatory framework, while the PMDA handles tasks such as product review and market surveillance.

For additional information about the MHLW, please refer to: Information Available in English｜Ministry of Health, Labour and Welfare｜Government of Japan｜厚生労働省 (mhlw.go.jp)

The PMDA's website also offers an English version, allowing access to various regulations, approved product lists, news, and more: https://www.pmda.go.jp/english/index.html.

Classification of Medical Devices in Japan

The approval and regulatory strategy for a specific medical device largely depend on its risk class, similar to other regulatory systems.

In Japan, medical devices are divided into four risk classes: Class I, II, III, and IV. Class I products represent the lowest risk, whereas Class IV products represent the highest risk.

In vitro diagnostics are classified into three risk categories: Class I, II, and III, with increasing risk from Class I to Class III.

The classification system in Japan is similar to that in the United States, as Japan also has databases that categorize a large number of products and defined product categories into specific risk classes. This regulation dates back to 2004 and is known as Yakushoku Notification No. 0720022.

Product classification into a particular product code and its associated risk class is determined using the "Japanese Medical Device Nomenclature (JMDN)": https://www.std.pmda.go.jp/stdDB/index_en.html.

Each product category and class has specific "Certification standards," "Approval standards," or "Review Guidelines" that apply.

Since 2009, the system has been updated to classify products into the following categories:

"Generic devices" (also known as "me too" products, which are essentially similar to existing products)
"Improved devices" (products that resemble existing ones but are not novel enough to be classified as "new")
"New devices" (novel products that are unlike any existing ones on the market; novelty can relate to aspects such as to intended use, technology, mode of action, etc.)

The path to approval and the effort involved vary depending on the risk class and the classification into one of the three categories.

Notification

Medical devices or in vitro diagnostics classified as Class I, associated with an extremely low risk to the human body, also known as "general medical devices"), do not require formal approval from the PMDA. Instead, a "Notification" (also called "Self Declaration," or "Todokede" in Japanese) is submitted to the agency. This notification is carried out by the local representative, also known as a "Marketing Authorization Holder" or "Designated Marketing Authorization Holder".

The representative submits details about the manufacturer, general details about the medical device, and the Japanese instructions for use to the authority.

Pre-market certification

The “Pre-market certification” (known as “Ninsho” in Japanese) is applied to most Class II medical devices as well as Class II in vitro diagnostics. Meanwhile, the pre-market certification is also applicable to some Class III products.

Class II products are also referred to as "Controlled Medical Devices" and are typically associated with a low to moderate risk.

For many of these products, standards known as "Japanese Industrial Standards (JIS)" exist, which is why they are also referred to as "specified controlled devices." The JIS are often national versions of international ISO standards.

In the Pre-market Certification process, these standards are also referred to as "Certification Standards."

Medical devices that comply with these requirements are examined by accredited organizations ("Registered Certification Bodies" or "RCBs") in Japan.

Pre-market approval

The "Pre-market Approval" process, called "Shonin" in Japanese, is applicable to the majority of Class III medical devices, to Class II products (including IVDs) for which there are no Certification Standards, and to all Class IV products.

Class III and IV devices are classified as "Specially Controlled Medical Devices" and are usually associated with a high to very high risk.

Compliance with regulatory requirements (Approval Standards/Criteria, Review Guidelines) is assessed directly by the MHLW, rather than by an independent third-party certification body.

As part of the Pre-market Approval process, compliance with the so-called "Approval Standards" and the "Review Guidelines" of the PMDA is assessed and evaluated.

The submission documentation consists of a technical file in the STED format. For products categorized as "new" or "improved," where safety and efficacy cannot be demonstrated with non-clinical evidence, a clinical study must additionally be provided.

Local Representative – MAH / DMAH

Foreign manufacturers require a local representative in Japan. This representative is either the "Marketing Authorization Holder - MAH" or the "Designated Marketing Authorization Holder – DMAH" in Japan. The DMAH does not hold the license for the registered product, unlike the MAH. Additionally, a DMAH cannot be appointed for Class I medical devices. The MAH/DMAH must have a registered business address in Japan and assumes full responsibility for the approved products.

The obligations of a MAH or DMAH involve:

Establishing a registered address in Japan
Meeting organizational and personnel requirements as per MHLW regulations
Applying for and maintaining product approvals
Implementing a quality management system according to MHLW Ordinance No. 169
Conducting market surveillance and vigilance**

Independent of whether a MAH or DMAH is listed in the approval application, manufacturing sites must be registered in advance. Domestic facilities register with local prefectures, while foreign manufacturing sites register directly with the PMDA.

Compliance with Quality Management System Requirements

In addition to product registration, manufacturers must fulfill quality management system requirements, which are defined in the MHLW Ministry Ordinance No. 169.

In 2021, the MHLW Ministerial Ordinance No. 169 was revised to harmonize with the requirements of ISO 13485:2016. Additionally, national requirements are listed in Chapter 3, such as MAH obligations (Article 66) or the reporting of adverse events (Article 69). The updated regulation’s requirements must be implemented by March 25, 2024.

To comply with these requirements, the manufacturer submits an application for a QMS inspection to the authority or to an RCB. Following the audit and subsequent conformity assessment, the JIS Q 13485 certificate is issued, which is valid for three years.

As Japan is part of the Medical Device Single Audit Program (MDSAP), the manufacturer can alternatively be certified through this program, in which case a QMS inspection by the authority or RCB would not be required.

Post-Market Phase

After being certificated, the Japanese labeling can be finalized. It is mandatory to include the Japanese labeling before the product is introduced to the market. In addition to meeting the Japanese language requirements, the importer must also be specified. The labeling requirements are defined in Article 63 of the PMD Act. One option is to apply the labeling at a warehouse in Japan.

The obligations related to market surveillance are mainly derived from the requirements of Ministerial Ordinance No. 135/2004 - GVP Good Vigilance Practice.

Safety data for medical devices is gathered through an obligatory complaint and feedback management system, as well as with repair and service information. Additionally, relevant information is supplied by the industry, science, and users.

The "Safety Manager" is responsible for the timely reporting and assessment of incidents involving medical devices and coordinates the necessary steps for risk evaluation. Depending on the severity of the incident, the MAH must submit a report to the PMDA within 15 days (for serious incidents) or 30 days (for non-critical incidents).

Product changes must either be reported (Minor Change Notification – MCN) or approved (Partial Change Amendment – PCA), depending on the type of change.