Medical Device Manufacturing/Import Business License

Basis of law

 Import :  Article 15 of the Medical Device Act and Articles 29 and 34 of the Enforcement Rules of the same Act

 Manufacturing :  Article 6 of the Medical Device Act and Article 3 of the Enforcement Rules of the same Act

Complaint overview

This is a civil affairs service where a person who wishes to obtain a medical device company license applies to the head of the local food and drug safety office.

* When applying for an import business permit, you must apply for more than one import item license/certification at the same time or report more than one import item at the same time.

Business license
required documents

• 1.  Medical device Manufacturing • Import business license application form

    ※  Sole proprietorship : Enter the registration base of the representative.

• 2.  In case of sole proprietorship : Health certificate for its representative

    ※  To prove that the representative is not mentally ill or addicted to drugs or other toxic substances

    ※  Validity period : Within 6 months from the date of issuance

• 3.  In case of Corporation : Certified copy of corporate register (confirmation by public official in charge)

• 4.  Documents confirming whether the quality manager meets the qualifications under Medical Device Act Article 11, Paragraph 2

License Amendment

• 1) Based law

  * Import :  Medical Device Act (Article 12) Medical Device Act Enforcement Rules Article 26 (1), Article 34

  * Manufacturing :  Medical Device Act (Article 12) Medical Device Act Enforcement Rules Article 26 (1), Article 34

• 2) When a change in business license is required

  -  Change of business name

  -  Changes due to transfer and acquisition

  -  Change of location

  -  Change of Quality Manager

  -  Change of representative

Change of Business license Applicable documents

1.  When applying in person, submit 1 copy of the application for change in medical device manufacturing (import) business license [Appendix Form No. 29]

2.  1 copy of permit

3.  Change of location : A copy of the consignment contract (in case of consignment of testing for the manufacturing process or quality control) and data proving compliance with the standards of the facility and manufacturing and quality control system according to [Appendix 2] (GMP conformity certificate)]

4.  Transfer and acquisition agreement (if the relevant manufacturing facilities, manufacturing methods, etc. are taken over due to separation or merger of a company, etc.)(The following information can be omitted as it is confirmed by the official in charge)

5.  1 copy of corporate register (if a corporation)

6.  1 copy of business registration certificate (if individual)