(1) Matters to be observed by a medical device importer under Article 13 (1) of the Act applied mutatis mutandis in accordance with Article 15
(6) of the Act shall be as follows:

1. The importer shall manage the facilities of an import business place in a sanitary manner not to cause any harm to health or hygiene and prevent cross-contamination or contamination, etc. from the outside;
2. The importer shall prepare and keep documents regarding the warehousing and release, and quality management of medical devices (including testing standards and methods, labeling, packaging, etc.) and management records on storage and shipment of accessories, and shall thoroughly conduct import and quality inspections based on such documents and records;
3. The importer shall prepare and keep the records of import and quality inspections under subparagraph 2 by import unit and the records of handling customers’ complaints, and shall retain such records for five years from the date of import (referring to a period corresponding to the product life cycle, where the product life cycle exceeds five years);
4. The importer shall release sterile products after verifying that the products have been sterilized;
5. The importer shall release electronic or mechanical products after ensuring their electronic and mechanical safety and electromagnetic safety;
6. The importer shall release products in direct or indirect contact with the human body after ensuring their biological safety;
7. The importer shall prepare and keep a manual of product specifications by item including the following matters:
8. The importer shall prepare and keep import management standards including the following matters:
9. The importer shall check whether an imported medical device has the labeling and packaging in compliance and prepare the records thereon;
10. The importer shall inspect product storage facilities and prepare the records thereon;
11. The importer shall ensure that a quality manager implements the following matters:
12. The importer shall take corrective measures, such as recall without delay, where the safety and effectiveness of released medical devices are undermined or the quality thereof is poor;
13. The importer shall formulate education plans to enable his or her employees to ensure the quality of imported medical devices, hold regular education and training sessions based on the plans, and prepare and retain records thereon;
14. Where the importer is aware of new data or information on the safety and effectiveness of a medical device permitted, certified, or notified (including cases of side effects in relation to the use of the medical device), he or she shall report it and prepare necessary safety measures as determined by the Minister of Food and Drug Safety;
15. For a factory of imported medical devices, the importer shall import and distribute medical devices manufactured in compliance with the standards specified in subparagraph 3 of attached Table 4. In such cases, medical devices imported for the purpose of the recognition of compliance under subparagraph 3 of attached Table 4 and recognized as compliant under that subparagraph shall be deemed imported after being recognized as compliant under that subparagraph;
16. The importer shall comply with the guidelines for export and import of medical devices publicly announced by the Minister of Trade, Industry and Energy under Article 12 of the Foreign Trade Act and regulations for management of imported medical devices determined by the Minister of Food and Drug Safety;
17. The importer shall apply the latest standard specifications determined by the Minister of Food and Drug Safety pursuant to Article 19 of the Act to maintain facilities and manufacturing and quality management systems, to import medical devices, and to conduct quality management or import management;
18. The importer shall thoroughly perform the affairs of post-market safety management, including re-review, re-evaluation, management of medical devices subject to tracking management, and management of safety information (including management of reports on side effects);
19. Where the importer imports secondhand medical devices or purchases medical devices imported by his or her company from a medical institution, he or she shall observe the following:
20. Where the importer is requested to conduct an inspection by a medical device distributor or lessor under subparagraph 1 (a) of Article 39, he or she shall observe the following:

(2) An importer shall report on the results of importing medical devices for the pertinent year to the Minister of Health and Welfare and the Minister of Food and Drug Safety as determined and publicly notified by the Minister of Food and Drug Safety under Article 13 (2) of the Act applied mutatis mutandis in accordance with Article 15 (6) of the Act: Provided, That such report need not be filed where a standard customs clearance forecast report has been filed in an electronic trade document under the Electronic Trade Facilitation Act.