5th Report of Market Access Ombudsman Council (March 17, 1998)

2-(1) Simplification of approval procedures for foreign manufacture of medical devices

1. Complainant: Taipei Economic and Cultural Representative Office in Japan

2. Ministry concerned: Ministry of Health and Welfare

3. Background:

(1) Approval, etc. needed for the import of medical devices

The Pharmaceutical Affairs Law stipulates that in order to import medical devices (those stipulated in Article 1, Attachment 1 of the implementing ordinance for the Pharmaceutical Affairs Law, under Article 2, Clause 4 of the said Law), permission for import and sale (Article 22 of the said Law) as well as approval for each product category (Article 14 of the said Law) must be obtained from the Minister for Health and Welfare (except for medical devices designated as exempt by the Minister).

Regarding approval of medical devices, a system under which foreign manufacturers can directly obtain approval for manufacture of medical devices (Article 19-2 of the said Law) was introduced in 1983.

(2) Approval of medical devices

In order to obtain approval, each medical device concerned must be evaluated to ensure that its structure, efficiency, performance, etc. are effective and safe. However, no approval is needed for product categories designated by the Minister for Health and Welfare.

Medical devices for which approval is not required for each product category (ministerial ordinance, Article 18) include 82 types used directly by medical professionals, whose effectiveness, safety and quality has been confirmed, and which are technically established, as well as 128 types already in widespread use whose effectiveness is well-known and which conform to the Japan Industrial Standards (JIS) in terms of quality and format and are based on existing medical and engineering knowledge.

The average processing period for approval is within one year for new devices, and within four months for most other medical devices.

(3) Requirements for approval of foreign manufacturers

When foreign manufacturers request approval directly from the Minister for Health and Welfare, they are required to appoint an in-country caretaker (ICC) (Article 19-2 of the said Law). Standards for appointing a ICC (ministerial ordinance Article 26-5) are the same as those for domestic manufacturers, etc. which are required to have a technical director on duty (ministerial ordinance Article 24, Clause 3).

(4) Systems in other countries

In the United States, medical devices (except for some low-risk items) require government certification before sale. In such cases, foreign manufacturers can obtain certification directly.

In the EU, a new EU Directive concerning regulations on medical devices is scheduled to be implemented in June 1998. Under this Directive, the CE marking must be applied to medical devices based on approval by third-party certification organizations (except for some low-risk items which are subject to self-certification). Foreign manufacturers may directly declare conformity to their products to requirements for CE marking.

4. Complaint:

According to the Pharmaceutical Affairs Law, approval procedures for medical devices (low-frequency treatment equipment and body-fat scales) to be imported take approximately one year. In addition, appointing and retaining an ICC is a considerable expense which is a great burden to businesses importing in small quantities.

Furthermore, requirement criteria for ICCs are stringent, making it difficult for foreign manufacturers to obtain approval directly.

Accordingly, the Complainant believes that the ICC system should be abolished and approval procedures simplified so that foreign manufacturers can apply for approval directly, as which procedure like the United States Food and Drug Administration (FDA) and the CE marking of the EU. In addition, mutual recognition should be introduced, so that FDA or CE marking certification can be used as an equivalent standard in Japan.

5. Results of deliberation:

According to the Ministry concerned, the specific responsibilities of the ICC which foreign manufacturers must appoint when applying for approval to manufacture medical devices are to collect information on any problems caused by the medical device in question and to retrieve defective products. On the other hand, the technical director which domestic manufacturers must employ is mainly in charge of supervising the employees working at the manufacturing plant (at the importer) and overseeing manufacturing equipment and materials; the technical director is not directly responsible for collecting information on problems, etc. Accordingly, the qualifications required for ICCs and for technical directors are the same, but their obligations under the Pharmaceutical Affairs Law are different.

The system of approval for foreign manufactures in the Pharmaceutical Affairs Law is praiseworthy because it establishes legal non-discrimination between domestic and foreign entities where approval procedures are concerned. It is also understandable that the safety of domestic users of medical devices must be guaranteed in some way. However, because the ICC is charged with collecting information on problems with medical devices, it is sufficient for this individual to have appropriate clerical processing abilities, and it is not necessary for the person to have the same qualifications as a technical director to carry out the duties concerned.

Regarding introducing the mutual recognition system, the ministry's acceptance of foreign test data in principle is a positive factor. Based on the recommendations of the Council, the government has undertaken to actively "promote mutual recognition", and should also actively promote mutual recognition of third-party certification in other countries, depending on the type of medical device in question.

Based on the above, the ministry concerned should take the following actions:

(1) Regarding the qualification requirements for the ICC needed for applications for approval of foreign products, 1) those requirements should be appropriate to the actual duties required; 2) ranks of risk should be introduced, in accordance with the degree of risk of the medical device in question. These actions should be studied and a conclusion reached during fiscal 1998.

(2) A study of expanding the range of product categories of medical devices for household use not requiring approval is already under way, but as recommended in the 4th Report of the Market Access Ombudsman Council (March 17, 1997), the results of study should be made public by March 31, 1998. Further, if approval is not necessary, this will eliminate the need for appointing ICCs as well, and the range of product categories of low-risk medical devices other than for household use should also be expanded.

(3) Active measures to promote mutual recognition should be taken, when other countries request meetings concerning mutual recognition for medical devices.

Government decision (March 23, 1998)

1-(1) Simplification of approval procedures for foreign manufacture of medical devices

(1) Regarding the qualifications for in-country caretakers required for application for foreign manufacturing approval of medical devices, the issue of dividing the required classifications into ranks, appropriate to the degree of responsibility actually required, and to the degree of risk of the medical devices in question, will be studied and a conclusion reached during FY 1998.

(2) Regarding expanding the types of medical devices for home use for which approval is not required, results of study will be made public by March 31, 1998. The types for which approval is not required, for other medical devices with low risk to health, will be expanded as well.

(3) Improvement of mutual recognition of medical devices will be actively undertaken in meeting with foreign countries.