Provisional Translation
| OTO No. | 587 | Classification | MHW-249 |
|---|---|---|---|
| Date of Acceptance | January 8, 1999 | Ministry/Agency Receiving Complaint | Economic Planning Agency |
| Responsible Ministries | Ministry of Health and Welfare | Related Laws | The Pharmaceutical Affairs Law |
| Complainant | Domestic firm | Exporting Countries | USA |
| Subject | International harmonization of testing methods for contact lenses | ||
| Details of Measures | Description of Complaint: 1. When applying for import approval for contact lenses, applicants are required to attach test results concerning human allergic sensitivity to the chemical substances contained in the lens ingredients. According to the ministry's guidelines, the chemical substances are to be extracted using an organic solvent, but obtaining the needed quantity of sample requires a very large number of contact lenses. 2. In the ISO10993 series tests used by many foreign countries, saline or vegetable oil in which contact lenses have been soaked are used as the sample, taking into consideration the actual conditions under which contact lenses are used, and only Japan requires the use of an organic solvent to extract the sample. 3. Therefore, Japan should review the above guidelines to harmonize its testing methods with international standards, by using the ISO series and so on, and should eliminate testing using organic solvents to extract samples. The ministry replied as follows: 1. Although extracts obtained by using saline or vegetable oil may be used in sensitivity tests, this extraction method cannot sufficiently extract fat-soluble substances which could be contained in tears and so on and is thus inappropriate for evaluating the risk posed by chemical substances. 2. Regarding the assertion that using the organic solvent extraction method requires a great number of contact lenses, requirements for the minimum amount of extracted material have been relaxed, and when it is difficult to obtain an extract, testing directly on contact lenses which have been ground into a powder is allowed. Further, since evaluation of sensitivity testing to new substances in the materials themselves is also conducted, this testing is not impossible to carry out. 3. Sensitivity testing methods are currently being discussed at the ISO, and Japan is asserting the scientific appropriateness of testing by using the organic solvent extraction method. This issue was also brought up during the 19th MOSS follow-up talks between Japan and the United States on January 28-29, 1999, and Japanese and American toxicity experts will continue to study the scientific appropriateness; the ministry would like to respond based on those results. 4. Biological testing methods to evaluate the biological safety of medical devices are currently set out in the guidelines, but since the details of specific testing methods and their implementation are not always necessarily clear, the guidelines will be clarified and reviewed as necessary, taking into account the opinions of parties concerned. |
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| Classification of Processing | A | Directions | I-a |
| Remarks | |||