Medical Device Registration in Japan

Utilize our intimate industry knowledge and expertise to obtain Japan PMDA registration approval for your medical device.

For a free consultation with an expert in Japan’s PMDA and MHLW regulations, contact us now.

Registration of medical devices in Japan is complicated, costly, and will generally take between 1-3 years depending on the device classification. In some cases, Japanese regulators require clinical trials in Japan to be conducted, and the costs of these trials can be very high. Product registration in Japan needs to be pursued carefully and only after determining that there is a strong market demand for your product.

We recently did a webcast about Japan Medical Device Registration and Reimbursement.

Medical device registration in Japan may require that you have PMDA consultation sessions. The first PMDA consultation session is normally for 30 minutes and is free. Typically at this free consultation, the PMDA will not answer your questions but recommend you attend a more formal PMDA consultation. Formal paid PMDA consultations can cover a variety of sessions including a pre-development consultation, a clinical trial consultation, etc. These formal PMDA consultations are not cheap, and the applicant needs to submit some appropriate regulatory information in Japanese, prior to each meeting.

In addition, before medical device registration in Japan, it is always best to determine likely reimbursement in Japan. Japanese will only use medical products/services if they are reimbursed. Reimbursement codes in Japan include A1, A2, A3, B1, B2, B3, C1, and C2. For the A reimbursement categories, all medical procedures including diagnosis and treatment are paid by a fixed fee. For the B categories, the costs of disposable one-time use medical devices are allocated by function category. C reimbursement categories will have a new function and/or have new therapies. Japan will also utilize foreign reference pricing (FRP). For FRP, Japan will take the unweighted average price of the US, England, France, Germany, and Australia. If the price in any one or two countries exceeds the specified Japanese formulas, the average foreign price may be determined by only 4 or 3 of these 5 countries.

As the use of software for medical purposes has become increasingly ubiquitous, in April 2021, Japanese health authorities established several new regulatory units dedicated to the review and approval of software as medical devices (SaMD). The regulatory unit at the MHLW is responsible for evaluating the safety and efficacy of SaMD products, while the office at the PMDA is in charge of reviewing applications by foreign medical device manufacturers. Japan is also considering the use of the “Sakigake” fast-track approval system on software-driven devices in order to accelerate the approval of innovative SaMD.

Pacific Bridge Medical can help you streamline the medical device registration process in Japan so that you can obtain approval for your product in the most cost-effective and timely manner. We can also act as your Marketing Authorization Holder (MAH) or Designated Marketing Authorization Holder (DMAH) in Japan. Our regulatory affairs consultants in Japan will ensure that you have maximum flexibility in your marketing and increased control over your brand.

PBM works with a number of Western CDx companies to register their CDx products in Japan. Please click here to learn more.

If you would like to learn more about the registration requirements and regulatory pathway for medical device products in Japan, please click on the following questions.

Which regulatory bodies in the Japanese government are responsible for medical device registration in Japan?

Main medical device regulation: Pharmaceutical and Medical Device Act (PMD Act)
Top government agency: Ministry of Health and Welfare (MHLW)
The PMDA is a division of MHLW and approves devices
Registered certification bodies (RCB) also review and approve device applications
RCBs are subject to periodic checks by the PMDA

In Japan, are medical devices required to be registered before they can be sold?

Yes, medical devices are required to be registered before they can be sold.

What are the different regulatory classifications for medical devices?

Class I Devices: General Medical Devices – The risk to patients in the event of malfunction is regarded as almost negligible (e.g. s-ray Film)
Class II Devices: Controlled Medical Devices – The risk to patients in the event of malfunction is regarded as relatively low (e.g. MRI, digestive catheters)
Class III Devices: Specially Controlled Medical Devices – The risk to patients in the event of malfunction is regarded as relatively high (e.g. artificial bones, dialyzer)
Class IV Devices: Specially Controlled Medical Devices – The device is highly invasive with potential fatal risk to patients (e.g. pacemaker, artificial heart valves)

What are the different application categories for medical device registration?

Application Category	Overview
New medical devices (clinical trial data required)	Medical devices that are clearly different from those with approval or certification in Japan in terms of structure, principle, method of use, efficacy, and/or performance. GCP clinical trial data must be provided to prove clinical safety and efficacy.
Improved medical devices (clinical trial data required)	This category is for medical devices that 1) do not have an applicable approval standard or do not meet the requirements of the approval standard; 2) cannot be proven to be “me-too” devices (refer to the “me-too” medical device section below); 3) are not regarded as new medical devices (refer to the section above); and 4) cannot be proven safe and effective with non-clinical data.
Improved medical devices (clinical trial data NOT required)	This category is for medical devices that 1) do not have an applicable approval standard or do not meet the requirements of the approval standard; 2) cannot be proven to be “me-too” devices (refer to the “me-too” medical device section below); 3) are not regarded as new medical devices (refer to the section above); and 4) can be proven safe and effective with non-clinical data.
“Me-too” medical devices (clinical trial data NOT required)	This category is for medical devices regarded as the “me-too” type that 1) do not have an applicable approval standard or do not meet the requirements of the approval standard; 2) are not regarded as new medical devices or improved medical devices (refer to the sections above); and 3) can be proven safe and effective with non-clinical data.
“Me-too” medical devices (clinical trial data NOT required and compliant with approval standards)	This category is for medical devices regarded as the “me-too” type that 1) have an applicable approval standard and meet the requirements of the approval standard; and, 2) can be proven compliant to the approval standard.

What does the registration pathway look like for each regulatory classification?

Class I Devices
- Category: “Todokede”
- Type: Notification; the MAH only needs to file a notification (Todokede) to the PMDA with no assessment by the PMDA.
Class II Devices:
- Category: “Ninsho”
- Type: Certification; the Class II devices specified as designated controlled devices (with certification standards) are subject to Ninsho. The MAH needs to file a Ninsho application with a notarized body to obtain their certification.
  - Note: certain Class II devices require both a review by the PMDA and a “Shonin” approval (see below) from the MHLW. Class II devices that do not meet the MHLW’s approval certification standards must file a Shonin application that is reviewed by the PMDA and subsequently by the MHLW.
Class III and Class IV Devices:
- Category: “Shonin”
- Type: Approval; the MAH has to file a Shonin application with the PMDA and obtain their approval. However, under the new regulations, some Class III products may only require Ninsho and not PMDA approval.

Approval Process:

Submit application to the PMDA (from MAH)
PMDA conducts:
1. Review against Essential Principles: Document review based on application for approval, Summary of Technical Documentation (STED), and attachments.
2. Reliability Review: PMDA conducts a QMS conformity assessment inspection at the manufacturing site. During the renewal of a business license a Periodic QMS conformity assessment inspection is conducted as part of the post approval inspection process.

Service/Activity	Document Preparation Time	Avg. Time for Approval, Certification, or Completion (after submission to the PMDA)
Class I – Notification	1 month after receiving a complete set of documents	0 days
Class II – Certification	2 months after receiving a complete set of documents	4-9 months
Class III – Application with approval standard, without clinical trial	2 months after receiving a complete set of documents	9-12 months
“Class III – Application without approval standard, without clinical trial	3 months after receiving a complete set of documents	12 months (me-too) or 15 months (improved)
Class III – Application (improved) without approval standard, with clinical trial	4 months after receiving a complete set of documents	16 months
Class III – Application (new) without approval standard, with clinical trial	4 months after receiving a complete set of documents	18 months
Foreign Manufacturer Registration (FMR) Application	1 month after receiving a complete set of documents	3-4 months
Quality Management System (QMS) Application for sterilized medical device	1 month after receiving a complete set of documents	about 75 days
Creation of a draft label and a product insert (if needed)	1 month	N/A

What are the document requirements for notification for Class I medical devices?

Documents Required to File a Notification/Pre-market Submission
Section	Information Required for Class I Devices
1	Category
2	Generic name
3	Proprietary name
4	Intended use
5	Shape, structure and principle, including the following items where applicable: Color photo Size and weight Components and accessories Electrical rating Block diagram When describing liquids, state clearly whether it is in the form of solution (clear), suspension, emulsion, etc.
6	Raw materials Quantity (weight, weight percent) Specifications (Standard number; JIS, ISO, ASTM, if applicable) Each raw material’s specification (Chemical and/or physical characteristics, etc.)
7	Product specifications (defined according to each product) Ex. Appearance, characteristics, etc.
8	Directions for use
9	Manufacturer(s) and manufacturing method: Flow chart from raw material acceptance to packaging, labeling and storage for shipment Name and address of entity responsible design and development of the product Name and address of manufacturer(s) of each manufacturing process including a manufacturer who does only labeling, packaging and storage License number or Foreign Manufacturer Registration (FMR) number with category of license or accreditation (non-sterile medical devices, sterile medical devices or packaging/labeling
10	Storage conditions and shelf life
11	Notes including those on the following items where applicable: Single use or not Usage of components of other medical devices
12	Package insert (directions for use) draft
13	Color photo (digital image)

What are the document requirements for registration for Class II medical devices?

Documents Required to File a Pre-market Certification
Section	Information Required for Class II Devices
1	Category
2	Generic name
3	Proprietary name
4	Intended use
5	Shape, structure and principle, including the following items where applicable: Color photo Drawings Size and weight Components and accessories Electrical rating Block diagram When describing liquids, state clearly whether it is in the form of solution (clear), suspension, emulsion, etc.
6	Raw materials and their specifications, including the following items where applicable: Quantity (weight, weight percent) Molecular weights Chemical name and /or structural formula CAS No. Purpose for its formulation Name of an official standard (EC, JIS, ISO, ASTM, JP, USO, EP, etc,) Vendors name Specifications (chemical and/or physical characteristics, etc.)
7	Product specifications and test methods (defined according to each product) Ex. Appearance, characteristics, biocompatibility, etc.
8	Directions for use
9	Manufacturer and manufacturing method: Flow chart from raw material acceptance to packaging, labeling and storage for shipment Name and address of entity responsible design and development of the product Name and address of manufacturer(s) of each manufacturing process including a manufacturer who does only labeling, packaging and storage License number or Foreign Manufacturer Registration (FMR) number with category of license or accreditation (non-sterile medical devices, sterile medical devices or packaging/labeling
10	Storage conditions and shelf life
11	Notes including those on the following items where applicable: Single use or not Use or nonuse of new raw materials Use or nonuse of biological materials Use or nonuse of genetic recombination method
12	Package insert (directions for use) draft
13	Color photo (digital image)

More Information Required for Class II Devices
Section	Information Required for Class II Devices
1	Summary of the product: Origin or background of development Category Generic name Proprietary name Classification Name of applicant Intended use Structure and principle Method for use and date of application If the product contains a new raw material.
2	Use in foreign countries: Name of countries where the product is marketed, approved date, approximate sales amounts Incidence of any report of serious malfunction or recall
3	Conformity with essential requirements Ex. Essential requirements for certification of product, ISO 14871:2000 & 2007 (risk management)
4	Description of the medical device: General information Evidence that raw materials are the same with exiting products/Specification of raw materials/sterilization method Explanation of new raw materials for its effectiveness and safety using test results Basis for setting up product specifications Comparison with an already approved product to show sameness
5	Statement that the product conforms to those standard defined by the MHLW
6	Stability and durability test results
7	Test results according to relevant ISO/JIS standard
8	Biological safety test results or a statement by an expert on toxicology, genotoxicity and/or carcinogenicity
9	Test results of electrical safety, electromagnetic compatibility and radiation safety (where applicable)
10	Risk analysis report according to JIS 14971 (ISO 14971)
11	Description of the label for the carton according to the guideline
12	Package insert draft
13	Risk analysis summary
14	Information on the manufacturing process
15	Information on quality control, description on the following items; Acceptance tests of raw materials Quality control tests on unfinished or finished products Release tests including package/label inspection

What are the document requirements for registration for Class III and IV medical devices?

Documents Required to File a Shonin Application Dossier
	Section	Information Required for Class III and IV Devices
Application Form	1	Medical Device Category JMDN Code and Class I, II, III, or IV If a single product belongs to multiple categories, select the category of the medical device with the highest risk class
	2	Name (General Nomenclature/Trade Name)
	3	Intended Use and Efficacy or Effects Target patient population and disease, usage conditions, anticipated effects, etc.
	4	Shape, Structure, and Principle
	5	Raw Materials or Components
	6	Product Specifications Specifications ensuring the quality, safety, efficacy of the device
	7	Operation or Usage Method
	8	Manufacturing Method
	9	Storage Method and Shelf Life
	10	Manufacturing Site of the Product to be Marketed
	11	Manufacturing Site of Raw Materials
	12	Remarks Medical device classification Package insert MAH license number of the applicant, etc.
Attachments	1	Origin or history until discovery and regulatory status in foreign countries Materials regarding background of origin or development Status of use overseas Comparison with similar medical devices
	2	Reason/background for specification Materials regarding specifications and setting of specifications
	3	Stability & Endurance Materials regarding stability and durability
	4	Document for compatibility with Essential Principle – Conformity to Essential Requirements (Article 41, Paragraph 3 of the PAL). Materials regarding declarations of conformity to Essential Requirements Materials regarding conformity to Essential Requirements
	5	Performance Materials regarding tests supporting performance and safety Materials regarding tests supporting efficacy Materials regarding tests methods of use
	6	Risk Analysis Materials regarding systems for implementing risk analysis Materials regarding important hazards
	7	Manufacturing (Process, QC, Sterilization) Materials regarding manufacturing processes and manufacturing facilities Materials regarding sterilization methods Materials regarding quality control
	8	Clinical Data Materials regarding test results of clinical trials Investigation plans (proposals) regarding records of use, etc. of new medical devices.
Summary of Technical Documentation (STED)	1	General overview of product Overview of product requiring color photos for confirming the outer appearance of the product Background of origin or discovery and history of development Status of use in foreign countries
	2	Essential requirements and conformity to the essential requirements List of reference standards Essential requirements and evidence of conformity using the checklist for conformity to the essential requirements
	3	Device description General information Raw materials Product specifications describing why the established product specifications are necessary and sufficient for securing the effectiveness, safety and quality of the product. Storage method and shelf life Comparison with similar medical devices
	4	Overview of design verification and validation documents General Information Declaration of Conformity to Standards Overview of validation of design Test to support device safety Physical and chemical properties Electrical safety and electromagnetic compatibility Biological safety Radiation safety Mechanical safety Stability and durability Tests to support performance Tests to support efficacy Tests to support usage method
	5	Test results of clinical trials Clinical trial results Summary of clinical trial results Other(s)
	6	Labeling Instructions for Use (Draft) Label (Draft)
	7	Risk Analysis System for implementing risk analysis Important hazards
	8	Manufacturing Information Information on manufacturing process and manufacturing facilities Sterilization method Quality control
	9	List of supporting data and attachments Ex. Certificate of conformity, test reports, etc.

What is Foreign Manufacturer Registration (FMR)?

Foreign companies that intend to manufacture drugs, quasi-drugs, active pharmaceutical ingredients (APIs) or medical devices overseas and import them into Japan must be registered with the Ministry of Health, Labor and Welfare (MHLW). This process is known as “Toroku”, or “Foreign Manufacturer Registration (FMR)”. It is a separate process from the product registration process, and is required for obtaining product registration approval. Previously, it was known as “Foreign Manufacturer Accreditation (FMA)” or “Accreditation of Foreign Manufacturers (AFM)”.

For more information about the FMR system and process, please view the Foreign Manufacturer Registration in Japan page.

What is a Marketing Authorization Holder (MAH) or a Designated Marketing Authorization Holder (DMAH)?

A entity that obtains a marketing authorization license is known as a market authorization holder (MAH), and only registered MAH entities may import and sell medical products to the Japanese market. Therefore, all foreign manufacturers must designate a MAH or DMAH to manage their product registrations.

For more information on MAH and DMAH, please view the Local Agent Representation for Medical Products in Japan (DMAH) page.

Is local testing (type testing/sample testing) required for registration?

No, type testing is not required for registration in Japan.

When are clinical studies required for registration?

Normally required for improved devices or new devices where safety and efficacy are not validated by non-clinical data
Can your Western clinical trials suffice in Japan? When you set up your GCP standards, did you meet Japanese GCP standards and have a Japanese investigator on board? Do you have Japanese patients in your Western clinical trials to alleviate ethnicity issues?
PMDA seems to accept more foreign data from larger Western device companies; tougher for smaller Western device companies to get foreign data accepted
If local clinical trials are needed, make sure you have the right KOLs and CRO company

Is approval in the Country of Origin required for registration?

No, approval in the Country of Origin is not required for registration; however, it is recommended.

For a free consultation with an expert in Japan’s PMDA and MHLW regulations, contact us now.

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