2. Based on the Pharmaceutical Affairs Law, there are (1) medical devices that are required to obtain approval from the Minister of Health, Labour and Welfare after examining their quality, usefulness and safety and (2) medical devices that are, as exceptional cases, not required to obtain such approval. The case (2) medical devices comprise the ones the Minister has designated as requiring no approval and the ones that comply with the Japanese Industrial Standard and the Minister has designated as such.
To obtain approval for case (1) medical devices, it is necessary to submit materials and data prescribed by the enforcement regulations of the Law to be examined by the Ministry of Health, Labour and Welfare. For diagnostic medical devices including thermometers and sphygmomanometers, which require being examined for approval, their measuring precision is verified when their performances are evaluated.
Medical devices that, according to the Ministry of Economy, Trade and Industry in past negotiations, have had many sub-standard products seem to belong to case (2), which requires no approval.

3. Although the Ministry of Economy, Trade and Industry (Ministry of International Trade and Industry) claimed the necessity of regulations based on the Measurement Law for aneroid sphygmomanometers in OTO No. 155 of 1984 because "they are indispensable to secure the safety of human life and the distribution of substandard ones will have a serious impact," the Pharmaceutical Affairs Law secures the performance, safety, etc. of medical devices. Given the fact that medical devices that, in some cases, have more to do with the securing of human life than aneroid sphygmomanometers, etc. are not subject to the regulations by the Measurement Law, the complainants cannot help but have doubts about the rationality of the Measurement Law making aneroid sphygmomanometers subject to it for the reason of securing human life.

4. Furthermore, as for the quality control and production control of overseas manufacturers, the Pharmaceutical Affairs Law already implements the medical GMPI (requirements for the control of the import and sale and the quality control of medical devices), imposing the obligation of confirming imported medical devices comply with the GMP of the manufacturing countries on importers/sellers. For example, the GMP of the United States includes inspections for manufacturers to secure the performance of products within themselves, so that the limits of measurement and precision of products are verified in ordinary inspections for performance. The Pharmaceutical Affairs Law also provides that, before the distribution in Japan of foreign products, importers/sellers confirm their performance and safety in compliance with the standard and test method prescribed in the approval document. Japan's industry for medical devices has already started to manage the system, and the system has been established as the procedure for securing quality. In other words, a system has been established for distributing medical devices in Japan that have passed inspections independently conducted by foreign manufacturers and Japanese importers/sellers, the first inspection at the time of shipment and the second when they are imported.

5. The "Three-year Plan for Deregulation (Revised)," a Cabinet Decision on March 29, 2002, specifies that "Globalization of economic activities has made progress, and standards and inspections/official certifications (hereinafter referred to as standard certification systems, etc.) have come to greatly affect corporate and consumer activities, such as the rise of costs and the limitation of choices. Therefore, in setting and managing standard certification systems, etc., arrangements must be made to make any impact on such activities as small as possible on the condition that there will be no impediment to achieving the various original policy objectives of such individual systems, such as protection of the life, body and properties of the people." This thinking of the government leads the complainant to believe it necessary to eliminate the duplicated inspection by the Measurement Law.

6. Considering the circumstances mentioned above, the Ministry of Economy, Trade and Industry should take measures to exclude from the application of the Measurement Law clinical thermometers and sphygmomanometers that are required to obtain approval based on the Pharmaceutical Affairs Law or GMPI for medical devices.

(Second Opinion)
1. The reply from the Ministry of Economy, Trade and Industry dated May 16, 2002 does not form a reply to the complaint made by the complainant on April 25, 2002.
Although the complainants pointed out the irrationality of the regulations by the Measurement Law concerning the present issue by giving more than one reasons, the ministry made no clear reply about them.

2. Although the Ministry of Economy, Trade and Industry stated in the reply dated May 16, 2002 that it held the recognition that official individual certification of measuring instruments was necessary, considering the fact that some clinical thermometers and sphygmomanometers imported from foreign countries did not pass official certification, an investigation by the ministry shows that the official certification has not rejected any units of "clinical thermometers and sphygmomanometers that are required to obtain approval based on the Pharmaceutical Affairs Law or GMPI for medical devices" (hereinafter referred to as the devices of the present issue), of which the complainants are requesting deregulation, and that the official certification has rejected some units of the devices except the devices of the present issue (the devices that are not required to obtain approval based on the Pharmaceutical Law).
Therefore, as for the present complaint, which limits the subjects of deregulation to the devices of the present issue, the ministry's assertion that "some clinical thermometers and sphygmomanometers imported from foreign countries do not pass official certification" cannot form the ground for excluding the present complaint. The devices of the present issue should instead be excluded from the list of the devices subject to the Measurement Law, being that there has not been any rejection of units of them.

3. If there are "any units of the devices of the present issue that have been rejected," the complainants would request the ministry to show the results of the certifications and the number of the pieces rejected.
If no units of the devices of the present issue have been rejected, the ministry's arguments lose validity. In such a case, the ministry should immediately take a measure to exclude the devices of the present issue from the list of the devices subject to the regulation by the Measurement Law.

(Third Opinion)
1. Although the Ministry of Economy, Trade and Industry cited, in the reply dated July 31, 2002, the fact that some measuring instruments did not pass official certification as a reason for recognizing that the official individual certification based on the Measurement Law is necessary, it also answered that "39 of the rejected units that were made in the United States were sphygmomanometers that had obtained medical device permit numbers under the Pharmaceutical Affairs Law." The complainants in question request exclusion of medical devices that require approval based on the Pharmaceutical Affairs Law from the application of the Measurement Law. Thus, the complainants would like to know whether medical devices with "approval numbers (not permit numbers)" have been rejected.

2. The ministry answered "The official certification based on the Measurement Law is, in the first place, implemented on the recommendation of the OIML, the international legal measurement organization of which the United States is also a member country, and it is pursuant to international rules." However, the complainants know that the recommendation does not require conducting official individual certification in addition to examination for approval based on the Pharmaceutical Affairs Law. European countries and the United States also conduct examination for approval of medical devices based on the law corresponding to the Pharmaceutical Affairs Law of Japan, but they do not conduct a type approval and official certification of the individual units based on the law corresponding to the Measurement Law. Japan only requires a type approval and official certification based on the Measurement Law.

3. In light of these, the Ministry of Economy, Trade and Industry should take a measure to exclude clinical thermometers and sphygmomanometers that require approval based on the Pharmaceutical Affairs Law or GMPI for medical devices from the application of the Measurement Law.

(Second Reply)
Based on the Measurement Law, the ministry conducts administration for measurement to prevent the distribution of substandard products within the country by setting technological standards needed to secure proper measurement and imposing official certification of measuring instruments.
15 imported sphygmomanometers (3 made in the United States) were rejected in fiscal 1999 and 87 (40 made in the United States: 38 exceeding tolerance, 2 module breakdowns) and 3,190 imported clinical thermometers were rejected in fiscal 2000.
39 of the rejected units that were made in the United States were sphygmomanometers that had obtained medical device permit numbers under the Pharmaceutical Affairs Law (it is not clear whether the remaining one unit is subject to approval by the Pharmaceutical Affairs Law).
Therefore, the assertion that "Since there have been no rejections, the devices of the present issue should be excluded from the list of devices subject to the Measurement Law" is built on a misunderstanding of the facts. To prevent the distribution of substandard units and secure proper measurement, which is the purpose of the Measurement Law, the ministry judges it necessary to implement the inspection of individual units based on the Law.
The official certification based on the Measurement Law is, in the first place, implemented on a recommendation of the OIML, the international legal measurement organization of which the United States is also a member country, making it a certification based on international rules.
(Actions taken by the ministry after the second reply)
The Weights and Measures Administration Council will conduct deliberation on desirable administration for measurement based on the Measurement Law in Japan for about one year from July 2005.
In the deliberation, the council will also discuss specific measuring instruments (consisting of 18 models, including clinical thermometers and sphygmomanometers).