The most significant and crucial step in the device approval process is the labeling aspect. The safe and proper use of medical devices by patients and those who provide care for patients depends on accurate labeling with all the necessary information to ensure market access. Article 63 of the " Act on Securing Quality, Efficacy, and Safety of Products, Including Pharmaceuticals and Medical Devices" specifies medical device labeling regulations for manufacturers who intend to market their products in Japan.

In Japan, labeling is listed on package inserts.  The package inserts must contain all the information in the Japanese language. The Market Authorization Holder (MAH) or manufacturer of medical devices must affix packaging inserts as a Clearance Release Judgement requirement. Packaging inserts can be affixed in the factory of the origin or done in Japan by the warehousing manufacturer. Manufacturers/MAH/DMAH must notify the MHLW before the medical device or IVD device can be marketed in Japan (or at the time of new approval) and when revising the package insert. Package inserts must include the following:

Date of preparation/revision

Indications

Japan's standard commodity classification number

Dosage and administration

Therapeutic category

Precautions

Regulatory classification

Pharmacokinetics

Name

Clinical studies

Warnings

Pharmacology

Contraindications

Physiochemistry

Description

Precautions for handling

Conditions for approval

Name and address of manufacturer or importer

Packaging

 

 

For the ease of device identification, the MHLW released a guideline on September 13, 2022 (Ordinance No.128 of 2022) specifying new barcoding rules for medical devices and In vitro diagnostics. The labeling of codes on containers, etc., to identify medical devices shall be implemented as described below to prevent accidents due to mishandling of medical devices, etc. in medical care, to ensure traceability, and to promote the efficient distribution of the same.

No.

Classification

Individual packaging

Packaging to be sold

Original packaging

Product code

Manufacturing identifier

Product code

Manufacturing identifier

Product code

Manufacturing identifier

Medical devices that fall under special treatment materials (I)

1

Implantable medical devices

2

Single-use medical devices other than 1

3

Reusable medical devices other than 1

Medical devices that fall under specially controlled medical devices or specially designated maintenance-and-management-required medical devices other than those specified above (II)

4

Implantable medical devices

5

Single-use medical devices other than 4

6

Reusable medical devices other than 4

Medical devices other than (I) and (II)

7

Implantable medical devices

8

Single-use medical devices other than 7

9

Reusable medical devices other than 7

In-Vitro diagnostics

10

-

Consumable materials used repeatedly for medical care exclusively at medical institutions, which are other than (I) - (IV)

11

-

*Reference Taken from the MHLW notification No. 0913-02

Each code shall be interpreted as follows:

Information that shall always be labeled in accordance with Article 68-2-5 of the Act

Information that shall always be labeled in accordance with this notification

Optional labeling

Terms used

  1. Product code: It must contain the GTIN (Global Trade Item Number), the identification code for GS1
  2. Manufacturing identifier: It must contain information specific to the manufacturer, such as validity/expiration date, lot number, serial number, etc
  3. Individual packaging: Packaging that wraps the individual device
  4. Packaging to be sold: the smallest packaging unit sold to medical institutions by wholesalers, etc
  5. Original packaging: That containing multiple packaging to be sold and packed by marketing authorization holders

The MHLW has specified the following cases wherein barcode labeling is exempted:

  1. Where the surface area of the container is small, identification codes shall be included in the document that accompanies the relevant medical devices and IVDs
  2. When medical devices or IVDs cannot be packed in the container owing to their structure and properties
  3. Labeling codes are not required for the devices and IVDs that are being exported

Labeling codes are not required during emergency approval of the devices or IVDs. However, they shall be placed as soon as possible.

One of the most important and closely examined aspects of the entire Regulatory process is labeling. The expense of incorrect labeling or negligence in including all necessary information can cause manufacturers a significant expense. Manufacturers may find it more cost-effective to outsource the labeling component to a trustworthy Regulatory partner, who will then assist them in the smooth placement of devices in the Japanese market.

To decode more about Japan's medical device labeling requirements, reach out to a Regulatory expert now!

 

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