Medical Device Standards in Japan

Risk-based framework and classification

The Pharmaceuticals and Medical Devices Act (PMD Act) regulates medical devices in Japan. The law, which came into force in November 2014, applies a risk-based concept: devices are classified into four risk classes and the regulatory pathway depends on the class. Table 1 on the PMDA standards site links the GHTF classes (A–D) with Japanese categories (general, controlled and specially controlled devices) and summarises the requirements for self‑declaration, certification, or approval:

Class	Device category (examples)	Regulatory requirements
Class I (A)	general medical devices (e.g., X‑ray film)	Self‑declaration – marketing notification is necessary but no approval is required.
Class II (B)	controlled medical devices (e.g., MRI, digestive catheters)	Certification – evaluation by a registered certification body when certification criteria exist; otherwise approval by MHLW.
Class III (C)	specially controlled medical devices (medium risk, e.g., dialysers)	MHLW approval unless specified certification criteria exist; clinical evidence may be required.
Class IV (D)	specially controlled high‑risk devices (e.g., pacemakers)	MHLW approval; PMDA conducts scientific review of safety and efficacy.

PMDA classifies applications as new devices (no precedent), improved devices (with or without clinical data), and generic devices. Generic devices that are equivalent to existing approved devices may follow simplified pathways, such as certification or self‑declaration.

Certification criteria

Certification criteria are standards for medical devices defined by the Minister of Health, Labour and Welfare (MHLW). Compliance is assessed by registered certification bodies; devices meeting these criteria can be certified instead of undergoing ministerial approval. The 2005 marketing certification system introduced this third‑party certification, allowing certain controlled devices and IVDs to be certified rather than approved. Certification criteria specify:

• Scope: a list of applicable devices identified by their JMDN codes.
• Intended use/indications subject to the criteria.
• Technical standards defining performance and safety requirements, often referencing Japanese Industrial Standards (JIS).
• Conformity to essential principles: the essential principles for medical devices are codified in Ministerial Announcement No. 122, and a checklist is used to determine compliance.

The criteria apply to generic devices that are substantially equivalent to existing products; devices with biological ingredients have additional coding requirements.

Approval criteria

Approval criteria unify technical requirements and tests for devices that do not require clinical data and are used to support regulatory approval. Composed of ISO or IEC standards, these criteria aim to ensure consistency across approvals. The PMD Act requires that anyone intending to market medical devices and designated in vitro diagnostics receive approval for each product when approval criteria apply. Approval criteria include:

1. Scope – JMDN codes for applicable devices.
2. Technical standards – performance, function and efficacy requirements.
3. Intended use/indications.
4. Conformity to essential principles – using the same essential principles checklist used in certification criteria.

These criteria also apply mainly to generic devices that are substantially equivalent to existing products and do not require clinical data.

Review guidelines

Review guidelines are issued by MHLW and PMDA to describe the technical requirements and acceptance criteria necessary to evaluate the safety and efficacy of medical devices. They aim to ensure efficient reviews by specifying:

1. Intended use/indications and the purpose of the review.
2. Scope – devices identified by JMDN and their intended indications.
3. Technical guidelines – performance, function and efficacy requirements, along with reference standards.
4. Conformity to essential principles.
5. Scope of application – review guidelines apply mainly to devices equivalent to precedent products in the Japanese market; new devices with innovative technology may fall outside the scope.

Japanese Medical Device Nomenclature (JMDN)

The JMDN (Japanese Medical Device Nomenclature) is a nomenclature system created in 2005 based on the Global Medical Device Nomenclature (GMDN). Each entry contains a general name, definition and an eight‑digit JMDN code that incorporates a risk‑based classification. The numbering rules specify that:

• The JMDN code consists of 8 digits; the first five digits derive from GMDN and three additional digits indicate subdivisions.
• If the added three digits are 000, there is no subdivision.
• The 1’s digit reflects differences in risk classification (e.g., body surface stimulators are Class I, subcutaneous stimulators are Class II and intramuscular stimulators are Class III).
• The 10’s digit indicates no difference in risk classification.
• The 100’s digit indicates that the device contains biological ingredients or comprises a different material (e.g., central venous catheters coated with heparin or antimicrobial coatings).

Keeping up to date

The PMDA standards database is continuously updated. The “What’s New” section on the site shows regular announcements; for example, between August and October 2025 the PMDA reported the establishment and revision of multiple JMDN codes and revisions to certification criteria. These updates reflect ongoing harmonisation with international standards and the introduction of new device technologies. Users can search the database for criteria and JMDN codes or browse lists by class. Since forms and submissions must be in Japanese, foreign manufacturers typically work through a Japanese Marketing Authorization Holder (MAH).

Q&A

Q1: What law governs medical device standards in Japan?
A1: The Pharmaceuticals and Medical Devices Act, effective from November 2014, regulates medical devices and introduces risk‑based classification.

Q2: How are devices classified and what are the regulatory pathways?
A2: Devices are classified into four risk classes (Class I–IV). Class I devices require self‑declaration; Class II devices may be certified by a registered certification body when certification standards exist; Class III and IV devices generally require approval by MHLW with a PMDA review.

Q3: What are certification criteria and when are they used?
A3: Certification criteria are standards for devices that allow third‑party certification instead of ministerial approval. They specify scope, intended use, technical standards and essential principles, and apply to devices substantially equivalent to existing products.

Q4: When do approval criteria apply?
A4: Approval criteria are used to support the regulatory approval of devices that do not require clinical data. They provide unified technical requirements and tests and apply mainly to generic devices.

Q5: What is the JMDN and why is it important?
A5: The Japanese Medical Device Nomenclature (JMDN) is a coding system based on GMDN. Each eight‑digit JMDN code identifies a device type, includes risk‑based classification and indicates differences in risk or presence of biological ingredients through its last three digits.

Q6: How can companies stay current with Japan’s device standards?
A6: The PMDA standards database publishes updates on new and revised JMDN codes and certification criteria. Companies should regularly check these updates and use PMDA’s search tools. Because submissions and communications must be in Japanese, it is advisable to work with a Japanese MAH.