WHAT CECAP OFFERS
CECAP offers many evaluation programs you may want to export your assistive products (APs) or assistive technologies for the handicapped persons to Japan based on the appropriate rules and conventions. The programs offered are as follows;
1.Authorized Clinical Evaluation of Assistive Products (ACEAP)
As mentioned from the top page, CECAP is authorized to perform ACEAP which is not a necessary requirement to purchase your APs in Japan, but is practically more important if the AP can be provided with public funding. Therefore, it is worth to ask how to apply for the ACEAP. All necessary processes to perform ACEAP has been formulated by the Association for Technical Aids (ATA) including how to evaluate (methods) and what to be evaluated (items) (http://www.techno-aids.or.jp/only in Japanese language).
2.Original Clinical Evaluation of Assistive Products (OCEAP)
We can also perform the Original Clinical Evaluation of Assistive Products (OCEAP) based on ACEAP. We respond to a request of clinical evaluation for your assistive products which is not included in ACEAP and this is currently under development or already commercially available. In that case, we develop the method and items for the evaluation in a committee organizing professionals at first when necessary and perform the evaluation based on the similar rules to ACEAP in the second category.
3. Monitoring evaluation
If you want to perform monitoring evaluation for a newly developed product before marketing in Japan, we can offer all necessary procedures to confirm how much your AP is accepted in Japan. The monitoring evaluation can include four kinds of monitor evaluation that are i) long-term and ii) short-term and iii) for a small number of subjects, and iv) for a large number of subjects. Necessary evaluation items by which your AP is evaluated will be decided through discussions within you and CECAP. In addition, an ethical review board which discusses on the ethics examinations is a must to perform any monitoring evaluation in Japan and is organized by CECAP within the procedures.
4.Ethics examination by CECAP ethical review board
As mentioned above, CECAP runs its own ethical review board by which the ethics examination is performed. Currently the ethics examination is a must whenever the monitoring evaluation is done.
There are i) “Ethic guidance about the clinical study” which is an administrative guidance about the methods and procedure from the Ministry of Health, Labor and Welfare and ii) “Ethic guidance about evaluating the assistive products” which is an advanced guidance submitted by ATA and a related academic association. Because CECAP ethical review board has a rule established based on these two guidances, the outcomes of ethics examination will be recognized as public results.
In the CECAP ethical review board, the chairperson is a medical doctor working as a professor in a medical university and committee members are organized by 4 or 5 other members including university professors and AP user, and female members.
Needless to say, CECAP performs any monitoring evaluations according to decision of the ethics committee.
5.Evaluation based on the engineering test
In collaboration with Oyama National College of Technology, we can perform the engineering tests according to JIS which stands for Japanese Industrial Standard, SG which stands for Safety Goods standard, and ISO, partly.
Even though we can not provide you official certification and labels, you can get equivalent results for them.