What Is Changing — Promulgated June 9, Effective December 10
The amended Medical Device Act (Act No. 21775), promulgated on June 9, 2026, takes effect on December 10. It rests on three pillars.
On September 14, the Ministry of Food and Drug Safety (MFDS) issued pre-announcements of draft amendments to the Enforcement Decree and Enforcement Rule (the Rule draft is MFDS Notice No. 2026-445). These are still drafts, so details such as the pre-review fee and procedure may change before final promulgation. Please check the MFDS notice itself for the comment deadline and fee amount.
This amendment is separate from the shift to a negative-list system for change approvals pre-announced in March, and from the amendment strengthening online monitoring of illegal ads promulgated on September 15 (Act No. 21949, effective March 16, 2027). The effective dates differ, so track them separately.
Pre-Review Becomes Law — Ask "Is This a Medical Device?" Before You File
The amended Act lets anyone planning to apply for approval, certification, or notification ask MFDS in advance to review whether a product is a medical device and how it is classified. The draft subordinate rules set out the scope, procedure, and fee. Once the review is a statutory civil service with requirements written into law, companies can more readily use the outcome as a basis for development planning.
This matters most for borderline products.
If you develop on the assumption of a lower class and are later placed in a higher one, clinical data, technical file review, and GMP preparation must be redone. If you launch a product as a non-device and it is later deemed a device, you face unlicensed manufacturing and sales exposure.
What to Prepare Before Requesting
An AI-Generated "Virtual Doctor" Cannot Recommend a Medical Device
The ban covers ads that use AI-generated voice, images, or video in a way likely to make consumers believe a doctor or other expert is recommending a medical device. The specific ad types subject to sanctions will be set in the subordinate rules.
Audit by creative asset, not by channel.
Contracts need updating too. We recommend adding to agency and influencer agreements a duty to disclose AI-generated content in advance, a prohibition on expert-endorsement formats, and takedown and indemnity obligations for violations.
Emergency-Introduction Devices and Wider Purchasing Channels — What Applies to Manufacturers and Importers
The former "rare and urgently needed medical devices" category is reorganized as "emergency-introduction medical devices," distinct from rare medical devices. The Act now provides a basis for designation and withdrawal, demand surveys, and supply planning, and the draft rules entrust import and supply, information provision, and demand surveys to the National Institute of Medical Device Safety Information.
The drafts also include ancillary changes, such as expanding the parties from which manufacturers and importers may purchase (central government agencies, local governments, and rental businesses). Companies importing products with no domestic substitute, or distributing through public bodies or rental channels, should check the provisions directly.
Two Months to Go: A Checklist for SMEs
KITIM supports companies from preparing device status and classification review materials to regulatory strategy and GMP readiness. If your product's classification is uncertain or you need an ad review process, please reach out through KITIM's consultation request.