When Must a Marketing Authorization Holder License Be Obtained?

Under Japan’s Pharmaceuticals and Medical Devices Act (PMD Act, commonly known as Yakujiho), obtaining a Marketing Authorization Holder (MAH) license is mandatory for placing medical devices on the market under a company’s own brand. The MAH serves as the legal entity bearing ultimate responsibility for the quality, efficacy, and safety of medical devices.

The MAH license for medical devices is classified into three categories based on the risk class of the products to be handled. Importantly, obtaining a license for a higher risk class allows the holder to also handle products in lower risk classes.

License Type	Applicable Device Risk Classification	Risk Level
Type I MAH	Specially Controlled Medical Devices (Class III, IV)	High Risk
Type II MAH	Controlled Medical Devices (Class II)	Medium Risk
Type III MAH	General Medical Devices (Class I)	Low Risk

The MAH license application is submitted to the prefectural governor having jurisdiction over the location of the business establishment where the General Manager of Marketing Authorization resides (typically the head office). Following submission, the prefecture conducts a conformity assessment (document review and on-site inspection). The license is granted upon confirmation of compliance with the PMD Act and related regulations. The license is valid for five years and requires renewal.

Primary Duties of Marketing Authorization Holders

MAHs are entrusted with the following critical responsibilities:

Pre-market activities include obtaining marketing approval, marketing certification, or filing notifications for medical devices. This encompasses clinical evaluation and responses to conformity assessments.

Quality management activities involve establishing and operating a Quality Management System (QMS) that manages the entire supply chain of medical devices being marketed. This includes design and development control, contract manufacturer management, incoming inspection, and release determination.

Post-market activities include conducting Post-Marketing Surveillance (PMS). This encompasses collection, evaluation, and reporting of adverse event information and infection information, as well as provision of safety information.

A crucial point requires attention here. Despite the nomenclature “Marketing Authorization Holder,” this license alone does not permit the actual “manufacturing” or “sales” of products.

To actually “manufacture” products, a separate manufacturer registration is required. This includes registration for design activities only (no registration category), registration for undertaking part of the manufacturing process (relevant manufacturing process category), and others. Additionally, to “sell” products, a sales business license or notification is required for Class II and higher medical devices.

Five Mandatory Responsible Persons

MAHs must appoint the following five legally mandated responsible persons as part of their organizational structure. Each of these persons must meet requirements stipulated by the PMD Act (educational background, practical experience, etc.) and is obligated to undergo periodic training.

The Supervising Manager is an executive officer who manages the MAH’s operations on-site, typically fulfilled by a representative director or similar position.

The General Manager of Marketing Authorization oversees all operations related to marketing authorization and ensures compliance with the PMD Act. This position requires either a pharmacist license or specified educational background and practical experience, and must be registered with the prefectural governor.

The Domestic Quality Operations Manager oversees operations related to quality control and quality assurance. This person ensures proper operation of the quality management system based on the QMS Ministerial Ordinance.

The Safety Manager oversees post-marketing safety management operations (PMS) and manages safety-related operations including adverse event reporting and recalls.

The General Manager of Medical Device Marketing Authorization is the designation when the General Manager of Marketing Authorization oversees medical devices comprehensively.

The requirements for concurrent service of these responsible persons vary depending on the type of MAH license. For example, under Type I MAH (specially controlled medical devices), there are restrictions on the General Manager of Marketing Authorization serving concurrently with other responsible persons. However, under Type III MAH (general medical devices), relatively flexible concurrent service is permitted. Each company must establish an appropriate structure according to the risk class of products they handle.

Timing for Obtaining the MAH License

A frequently asked question among startup companies is, “By when must the Marketing Authorization Holder license be obtained?”

In conclusion, the MAH license must be obtained at the latest by the time of product approval acquisition, certification acquisition, or notification filing. More specifically, the MAH license must already be obtained at the time of submitting a product application (approval application or certification application). This is because the MAH license number must be stated in the product application form, and entities without a license cannot submit applications at all.

Therefore, it is essential to plan for obtaining the MAH license from the early stages of product development and proceed with preparations by working backward from the timing of product application. License acquisition requires considerable time (typically 3-6 months) for organizational structure establishment, procedure documentation, responsible person appointment, preliminary consultations with prefectural authorities, and preparation for conformity assessments. Early initiation is highly recommended.

Necessity of ISO 13485 Certification

Third-party certification of ISO 13485 (international standard for medical device quality management systems) is not a legal requirement for obtaining an MAH license. Under Japan’s PMD Act, compliance with the QMS Ministerial Ordinance is required, which is verified through conformity assessments by prefectural authorities. ISO 13485 certification is voluntary and obtained at the company’s discretion.

However, obtaining ISO 13485 certification offers the following advantages. First, it objectively demonstrates compliance with international quality management standards. Second, when considering overseas expansion, ISO 13485 certification is required or recommended in many countries and regions. Third, since the requirements of the QMS Ministerial Ordinance are based on ISO 13485, obtaining ISO 13485 certification may facilitate responses to prefectural conformity assessments.

Therefore, it is appropriate to determine the necessity of ISO 13485 certification according to the company’s business strategy and future plans.

Comparison with Other Countries

Japan’s MAH license system functions as pre-market regulation that evaluates the structure and capabilities of business operators before product marketing. This serves as an important regulatory framework for ensuring product quality and safety.

In contrast, the United States and the European Union (EU) do not have business operator licensing systems equivalent to Japan’s MAH license. These regions adopt a product-based regulatory approach, conducting approval, certification, or conformity assessment of individual products on the premise that business operators have established appropriate quality management systems.

Specifically, in the United States, Establishment Registration with the Food and Drug Administration (FDA) and Device Listing submission are required. However, this serves more as information provision to enable regulatory oversight rather than permission to commence business. Regarding quality management systems, compliance with the FDA’s Quality System Regulation (QSR, 21 CFR Part 820) is required, and market entry is permitted through product-specific applications such as 510(k) submissions or Premarket Approval (PMA) applications.

In the EU, under the Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746), manufacturers establish quality management systems (ISO 13485-based) and undergo conformity assessment by Notified Bodies to affix CE marking and market products. While this system presupposes manufacturers’ legal responsibilities and quality control structures, there is no pre-market business operator licensing system like Japan’s.

Thus, Japan adopts a system that pre-evaluates and licenses the structure of business operators, whereas the United States and EU employ regulatory designs centered on product-by-product evaluation. This represents a significant difference. Companies aiming for global expansion must understand the characteristics of regulations in each country and region and formulate appropriate strategies.