1. If the two cases in Item (1) of Article (4) hereunder do not apply to the product, the supplier shall provide "a risk assessment report on the product or its aspects" to the Ministry, provided that it is issued by any of the following Approved Entities: a. A factory holding recognition, accreditation, or approvals that its product is safe. b. The competent authority. c. A university, center, laboratory or qualified research and study institute approved by the Ministry. d. A health or medical center approved by the Ministry. e. Any other authority accepted by the Ministry. 2. The Ministry shall examine and accept the report refe rred to in Item (1) above and shall issue the appropriate decision thereon.
Interpretation and application must be checked against the official text and current version.