Registration Process of Medical Products (Class III & IV) in Japan
Due to the complex registration process and strict regulatory supervision of medical products worldwide, medical product manufacturer should be able to understand the local registration process and regulatory affairs exactly, so that a successful market approval of the product can be achieved. This document aims to give a brief introduction to the initial registration process of the medical product (Class III & IV) in Japan.
In Japan, medical device regulations are overseen by the Pharmaceutical and Medical Devices Agency (PMDA), which is a division of The Japanese Ministry of Health, Labour and Welfare (MHLW). Foreign manufacturers who do not have a local office in Japan, are required to appoint a Designated Marketing Authorization Holders (D-MAH) to deal with the PMDA on their behalf. The other prerequisite for registration application is that the manufacturers meet the requirements of Quality Management System (QMS) under the Ordinance #169 of MHLW, which is based largely on the ISO 13485 quality management standard.
In Japan, medical devices are classified as Class I, II, III, and IV based on increasing risk levels using the database named as Japanese Medical Device Nomenclature (JMDN), among which the class I products need a premarket submission, the specified controlled Class II products need a premarket certification and the highly controlled Class II, III and IV products shall have a premarket approval. Each type of medical device has a single corresponding JMDN code and classification. Thus, the first step of product classification is to find the right JMDN code for the devices.
The following table shows some typical examples for the classification:
The following shows the documents requirement for registration application for Class III & IV medical products.
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
- Name (General Nomenclature/Trade Name)
- Intended Use and Efficacy or Effects
- Target patient population and disease, usage conditions, anticipated effects, etc.
- Shape, Structure, and Principle
- Raw Materials or Components
- Specifications ensuring the quality, safety, efficacy of the device
- Operation or Usage Method
- Manufacturing Method
- Storage Method and Shelf Life
- Manufacturing Site of the Product to be Marketed
- Manufacturing Site of Raw Materials
- Medical device classification
- Package insert
- MAH license number of the applicant, etc.
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
Reason/background for specification
- Materials regarding specifications and setting of specifications
Stability & Endurance
- Materials regarding stability and durability
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
- Materials regarding tests supporting performance and safety
- Materials regarding tests supporting efficacy
- Materials regarding tests methods of use
- Materials regarding systems for implementing risk analysis
- Materials regarding important hazards
Manufacturing (Process, QC, Sterilization)
- Materials regarding manufacturing processes and manufacturing facilities
- Materials regarding sterilization methods
- Materials regarding quality control
- Materials regarding test results of clinical trials
- Investigation plans (proposals) regarding records of use, etc. of new medical devices.
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
- 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
- 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
Overview of design verification and validation documents
- 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
Test results of clinical trials
- Clinical trial results
- Summary of clinical trial results
- Instructions for Use (Draft)
- Label (Draft)
- System for implementing risk analysis
- Important hazards
- Information on manufacturing process and manufacturing facilities
- Sterilization method
- Quality control
List of supporting data and attachments
- Ex. Certificate of conformity, test reports, etc.
The regulation of Class I medical devices is much looser compared with products in higher risk classes. The manufacturer shall only submit Pre-Market Submission documents to PMDA in Japanese, and for most Class I product the QMS conformity assessment is not required.
The following shows the required documents for Pre-Market Submission of Class I products:
Information required for class devices
- Generic name
- Proprietary name
- Intended use
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.
- Quantity (weight, weight percent)
- Specifications (Standard number; JIS, ISO, ASTM, if applicable)
- Each raw material’s specification (Chemical and/or physical characteristics, etc.)
Product specifications (defined according to each product)
- Ex. Appearance, characteristics, etc.
- Directions for use
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
- Storage conditions and shelf life
- Notes including those on the following items where applicable:
- Single use or not
- Usage of components of other medical devices
- Package insert (directions for use) draft
- Color photo (digital image)
Written by Liyu Huang (Regulatory Expert from DeviceMaster GmbH)
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