(1) Reasons for Proposal

This amendment aims to determine necessary details regarding certification, evaluation, etc., of medical device software manufacturing enterprises in accordance with Article 24 of the Medical Device Industry Promotion and Innovative Medical Device Support Act and Article 8 of the Enforcement Rules of the same Act.

(2) Major Provisions

A. Organization and operation of the medical device software manufacturing enterprise certification evaluation council (Articles 3 through 5) 

Set forth details necessary for the organization, operation, etc., of a certification evaluation body to advise on the certification of medical device software manufacturing enterprises.

B. Criteria for medical device software manufacturing enterprise (Article 6) 

Set forth certification criteria, such as organization, personnel, and R&D.

C. Software enterprise certification application and evaluation (Articles 7 and 8) 

Specifically decide the documents to be submitted when applying for certification and prescribe necessary details for certification evaluation, such as document review and fact-finding surveys on submitted data.

D. Changes to software enterprise certification and extension of the validity period (Articles 8 through 11) 

Provide the details necessary to apply for a change, reissue a certificate, and apply for an extension of the validity period of a certificate when changes occur in certified items.