1. Reasons for Amendment

 In order to quickly identify patients and use the information for safety measures in the event of an adverse effect of a medical device subject to tracking management, this amendment clarifies to whom users, who are delegated by the Ordinance of the Prime Minister pursuant to Article 50 (6) of the Enforcement Rule of the Medical Devices Act, must semi-annually submit records of medical device subject to tracking management, and revises the method of data submission.

2. Major Provisions

A. Divide the paragraphs on records and data submission into handlers and users, and specify to whom users must submit materials semi-annually (Articles 1 and 3)

B. Delete “computer media (referring to diskettes or CDs)” among the previous methods for submitting records and data (Articles 2 and 3)