1) Medical Prescription (Rx)
Medical errors and accidents happen so frequently that the need to standardize the supply chain from manufacturers to patients is widely recognized in the healthcare industry. And the Ministry of Health, Labour and Welfare (MHLW) announced an invitation for public comments on the draft "Implementation Guideline for Bar-coding of Prescription Drugs" in March 2006. This guideline was drafted with the full cooperation of FPMAJ and GS1 Japan. After gathering various comments from the public up until June, MHLW announced the guideline in September 2006.
This guideline adopts GS1-128, GS1 DataBar Limited and GS1 DataBar Limited Composite Symbology as well as GS1 DataBar Stacked and GS1 DataBar Stacked Composite Symbology as shown in Table 4.1.1-1.

Table 4.1.1-1 Current Guideline for Pharmaceutical Products

Japanese pharmaceutical manufacturers are already familiar with the guideline prepared by the MHLW and FPMAJ. After the guideline announcement, the manufacturers prepared "package change notifications" and sent them to wholesalers, medical institutions, and dispensing pharmacies across Japan.
The use of bar-coding systems is spreading at a fast pace among wholesalers and medical institutions, as well as manufacturers, for the purpose of preventing medical accidents, improving business efficiency, and assuring traceability.

Fig.4.1.1-1 Example of Package Change Notification

2) Over the Counter (OTC)
MHLW has not yet commenced a standardization initiative for over-the-counter (OTC) drugs.

1) The guideline issued by JFMDA
The Japan Federation of Medical Devices Associations (JFMDA) resolved to use the EAN/UCC-13 and UCC/EAN-128 codes in 1998, which was followed by the publication of the guideline in 1999 with the help of GS1 Japan. However, the use of these standards had been optional for each company.
In March 2003, MHLW published its "Vision for the Medical Device Industry." The accompanying "Action Plan" strongly encouraged the industry to promote the use of information technology systems to build a new product database and use bar codes to increase patient safety.
In 2004, for the purpose of inducing the implementation of the agreed-upon standard, MHLW started monitoring its use through JFMDA. MHLW has also been monitoring the coverage of item registration in the database.
In 2005, the revised guideline was announced in which the use of GS1 DataBar Composite Symbology is additionally recommended for very small items.

Table 4.1.2-1 Current Guideline for Medical Materials and Devices

2) Implementation of JFMDA Guideline
According to the survey conducted by MHLW in 2006, 56.3% of medical devices existing in Japan are registered in MEDIS-DC database and 70.2% are shipped with GS1-128 symbol labels as shown below.

Table 4.1.2-2 Barcoding Medical Devices in Japan

3) GS1 System for Surgical Instruments
In November 2006, the Japan Association of Medical Equipment Industries (JAMEI) published the first guideline for laser marking 2D symbols on surgical instruments for the purpose of ensuring patient safety, enabling traceability and providing effective inventory control at hospitals. Since the popularity of the QR Code has made it the de facto standard in Japan, JAMEI has selected QR Codes in addition to DataMatrix as their standard 2D data carrier.