4th Report of the Market Access Ombudsman Council (March 17, 1997)

2-(1) Relaxing import procedures for medical equipment in categories not yet approved

1. Complainant: Tokyo Chamber of Commerce

2. Ministry concerned: Ministry of Health and Welfare

3. Background:

In order to manufacture, import medical equipment (equipment or devices intended to diagnose, treat or prevent illness in humans or animals, or to have some effect on the structure or function of human or animal bodies and specified by statute) manufacturers and importers must obtain a permit to do so, as stipulated by Articles 12 and 22 of the Pharmaceutical Affairs Law.

Under Articles 14 and 23 of the same law, except for medical equipment specified by the Minister of Health and Welfare (medical equipment that does not require to get approval for each product category) each product category of medical equipment manufactured, imported must be evaluated tested for structure, benefits, effects, performance, standards, etc. to determine that there are no problems as far as quality, efficacy or safety are concerned, and approval obtained from the Minister of Health and Welfare.

Medical equipment is divided into three classes, from I to III. Class I equipment is that which requires no approval and which does not touch the body, or among types of equipment which touch the body, has no major impact on the body in case of malfunction. After changes to the law in 1994, the overall ratio of Class I equipment rose from 5% to 30%. Class III equipment is that which is implanted in the body. Since this equipment is directly related to sustaining life, risk control is carried out for each type of equipment. Class II equipment is that which is in neither Class I nor Class III and which requires approval for each product category.

Medical equipment which requires no approval by product category (Class I medical equipment) includes 82 types of equipment and that which meets Japan Industrial Standards (JIS). These 82 types of medical equipment are used directly by professionals. Since their efficacy, safety and quality have been confirmed and their use has become established in technical terms, they require no approval. Similarly, no approval is required for medical equipment conforming to JIS standards which is already in common use, whose usefulness is known and vouched for, and which meets quality and performance standards from the perspective of medical and engineering knowledge and stipulated by JIS. However, the equipment for home treatment which is the subject of this complaint falls under Class II and thus requires approval.

In other countries, in the United States for example, no distinction is made between home and professional use where medical equipment is concerned. Although approval to manufacture medical equipment, including electric therapy devices for home use and electronic blood pressure measuring instruments, is required under the Medical Equipment Safety Act, no approval is needed for massage chairs and certain other products for home use. In the case of those products, the manufacturers themselves must prove the quality, safety and so on of the products, as called for in the Consumer Products Safety Act. Similarly, the EU makes no distinction between medical equipment for home and professional use. Products are supervised under the Medical Devices Directive, with procedures required in proportion to the risk involved to the body. Where home massage equipment is concerned, procedures are necessary according to the classifications described below.

(1) Low-risk treatment devices

Self-certification record (of quality, efficacy and safety of the product itself, evaluation of quality control capabilities at the place of manufacture) to be drawn up by manufacturer (e.g. permanently magnetized treatment devices)

(2) Devices other than those in (1) above

Certification (of quality, efficacy and safety of the product itself, evaluation of quality control capabilities at the place of manufacture) by third parties approved by public health bureaus of EU member countries to be obtained (e.g. massage devices, electromagnetic treatment devices)

4. Complaint:

Simple massage equipment, magnetic health devices and other equipment used for personal health care are basically treated in the same way as authentic medical equipment, requiring MHW pharmaceutical approval procedures. It is not necessary for simple health care devices with little possibility of having adverse effects on life or health to be treated the same way as authentic medical equipment intended for professional use, and accordingly, simple devices used for personal health care should be exempt from the pharmaceutical approval requirement.

5. Results of deliberation:

Safety regulations intended to protect public health should be kept to the minimum consistent with the intended objectives. Overly stringent regulations not only impose a burden on businesses, they also have adverse effects from the consumer's perspective by restricting market access for foreign products, limiting the range of choice among available products and keeping prices high. As well, it is important to establish and make public clear guidelines for examination of applications and to provide information, from the viewpoint of ensuring transparency.

The concerned ministry has so far taken steps to eliminate the approval requirement, by establishing specifications and so on, for medical equipment whose quality, efficacy and safety has been established, but further actions should be taken, as described below.

(1) Regulations concerning medical equipment, including the scope of equipment requiring approval or not, differ in Japan, the United States and Europe. However, the ministry should take steps to promote international harmonization. It should also make public the conditions required for exemption from approval and when it is decided that approval is no longer necessary for certain types of medical equipment, announce the reasons for its decision.

(2) It is unnatural to require that home health care equipment like massage devices, magnetic health devices and so require the same approval as medical equipment for professional use. The matter of eliminating the approval requirement for such devices should be studied and a conclusion reached by the end of FY1997.

(3) Procedures in connection with elimination of the approval requirement should be established, by making clear which department parties wishing to have their products exempted from approval may address for this purpose.

Government decision (March 25,1997)

2-(1) Relaxing import procedures for medical equipment in categories not yet approved

(1) Since regulations on medical devices differ from each other between Japan, USA and EU efforts will be made to harmonize them including the scope of equipment for which approval is required.

The requirements which must be met in order for medical equipment not to require approval will be made public. The reasons why a decision was made that the medical equipment in question no longer requires approval will also be explained.

(2) The matter of no longer requiring approval for massage apparatus and magnetic energy health equipment for home use will be studied and a conclusion reached by the end of FY 1997.

(3) The department which parties wishing to have their equipment exempted from approval can consult will be made clear, and procedures for not requiring approval will be established.