Do Medical Devices Need KC and Radio Certification in Korea — Electrical Safety Is Exempt, Wireless Is the Fork

Key takeaway — "We have the device approval, so KC is done" is half right. The electrical-appliance KC procedures are exempted squarely by the Enforcement Rule. Radio certification is different: the Enforcement Decree annex writes the exemption narrowly — for the medical device item it lists conformity registration and self-conformity confirmation, and conformity certification, the route wireless equipment takes, is not on that line. For a product with Bluetooth or Wi-Fi, that one line decides both schedule and cost. Compiled on 8 September 2026 from the Enforcement Rule, the Radio Waves Act and its Decree annex, the radio research institute notification and the MFDS standard.

Three schemes, three questions

Scheme	Basis	What it examines
Device approval, certification or notification	Medical Devices Act Articles 6 and 15	Safety and performance of the product; electromagnetic safety is one review item
Electrical-appliance KC	Electrical Appliances and Consumer Products Safety Control Act	Safety as an electrical appliance
Radio conformity assessment	Radio Waves Act Article 58-2	Effects on the radio environment and communications networks, and electromagnetic behaviour

All three can meet in one product. How far the exemption runs is written not in the statutes but in an Enforcement Rule and a Decree annex, so reading the Acts alone does not answer the question.

1. Electrical-appliance KC — the Enforcement Rule exempts it

First, a point of precision. The word "medical device" does not appear in the body of the Electrical Appliances Act. The statute delegates the exemption ground as "other cases in which safety is recognised under other statutes, as prescribed by Ordinance of the Ministry of Trade, Industry and Energy" (Articles 6(9), 16(7) and 24(5)). The substance sits in the Enforcement Rule.

Enforcement Rule	What it exempts
Article 17	Safety certification
Article 35	Safety confirmation reporting
Article 47	Supplier conformity confirmation reporting

All three use the same wording in paragraph 1, subparagraph 3 — "where manufacturing approval or certification has been obtained or manufacturing notification made under Article 6 of the Medical Devices Act, or import approval or certification obtained or import notification made under Article 15 of the same Act" — and exempt the procedure in paragraph 2.

Two things not to miss.

• Certification and notification count, not only approval. Class 1 notification, Class 2 certification and Class 3 or 4 approval all fall within it, and the import track is worded the same way.
• A parenthesis limits the scope. Article 17(1)3 closes with "limited to electrical appliances subject to safety certification". This is an electrical-appliance exemption. The consumer-products exemption grounds list the Industrial Standardization Act and the Special Act on the Safety of Children's Products, and the Medical Devices Act does not appear there.

So the accurate statement is not "medical devices fall outside the Electrical Appliances Act" but "once the device approval, certification or notification is in place, the electrical-appliance KC procedure is exempt." The product remains within the concept; the procedure is what is waived.

2. Radio certification — this is the fork

Article 58-2 of the Radio Waves Act sets out four assessments for broadcasting and communications equipment.

Type	Basis	Nature of the equipment
Conformity certification	Paragraph 2	Equipment liable to harm the radio environment or communications networks, or causing or receiving serious electromagnetic interference. Wireless equipment sits here
Conformity registration	Paragraph 3	Equipment not subject to conformity certification
Self-conformity confirmation	Paragraph 4	Low-risk equipment prescribed by Presidential Decree
Provisional certification	Paragraph 9	Where assessment is impracticable for want of criteria

The exemption sits in Article 58-3, not 58-2. Its paragraph 1, subparagraph 4 covers cases "where conformity assessment for electromagnetic interference and protection equivalent to that under this Act has been undergone under related statutes", and item (f) names "medical devices approved, certified or notified by product class or product under the Medical Devices Act."

That reads like a full exemption. But the same paragraph says the Presidential Decree prescribes equipment for which "all or part of the conformity assessment" may be exempted. What "all or part" means is set by Enforcement Decree Article 77-7 and Annex 6-2.

Annex 6-2 item 4 — conformity certification is not in the exemption

For the equipment under Article 58-3(1)4, which includes medical devices, Annex 6-2 item 4 states the content of the exemption as:

conformity registration and self-conformity confirmation under Article 58-2 (3) and (4)

Items 1 to 3 of the same annex state their exemption content as "conformity certification, conformity registration and self-conformity confirmation under paragraphs (2), (3) and (4)". Only in item 4 is paragraph (2), conformity certification, absent.

The same direction appears in Annex 1 of the radio research institute's Notification on Conformity Assessment of Broadcasting and Communications Equipment (issued and effective 24 July 2026). The note recording the medical device exemption sits inside item 11, equipment causing or affected by electromagnetic interference, and does not appear in the earlier items covering radio equipment. In the same annex, "implantable wireless medical devices" are marked as subject to conformity certification.

What the text therefore supports is this. A device approval exempts conformity registration and self-conformity confirmation on electromagnetic grounds; the part that becomes subject to conformity certification because of a wireless function is not covered by that exemption wording. For a product carrying a Bluetooth or Wi-Fi module, the wireless conformity certification belongs on its own track.

The exemption carries one further condition

Annex 6-2 item 4 is not simply "medical devices are exempt". The condition is in the text — the conformity assessment criteria applied under the related statute must be equal to or above the permitted levels of the electromagnetic compatibility standards under Article 47-3(1) of the Act and Article 67-2 of the Decree.

A comparison of standards is therefore a premise. Whether that condition is met varies by product category and would require comparing the numerical limits, so this guide records only that the condition exists.

The exemption confirmation can be omitted

Article 21 of the Notification requires an exemption confirmation form and supporting documents in paragraph 1, and then allows in paragraph 4(3) that the procedure may be omitted for equipment falling under item 4 of Annex 6-2. The medical device electromagnetic exemption falls there.

3. So where is electromagnetic safety examined? In the approval review

For the part where radio certification is exempt, the MFDS review takes on the electromagnetic question.

• The standard — Common Standard on Electromagnetic Safety of Medical Devices (MFDS notification). Article 2 sets the scope as devices using electrical or electronic circuits, with Annex 1 covering emissions and Annex 2 immunity. The parent provision is Article 19 of the Medical Devices Act
• The submission — Article 26(1)4(d) of the Regulation on Approval, Notification and Review of Medical Devices requires electromagnetic safety data for devices using electrical or electronic circuits
• Acceptable evidence — Article 29(1)7 of the same Regulation: a report from a testing body designated by the MFDS Minister, an IECEE CB report, a report evaluated in an approval in an OECD member country, or a report from an ILAC-recognised laboratory accredited to ISO/IEC 17025. The model name must match the product. The criteria are the Common Standard or an equivalent or higher international standard such as IEC
• The Class 2 relaxation — under Article 28(1), for Class 2 devices Annex 7 may waive, among the Article 26(1)4 materials, the rationale for the test specification and the measured values. The test report itself is not waived

4. In practice — how many tracks does the product take?

Product type	Electrical KC	Radio conformity certification	Radio registration / self-confirmation	MFDS electromagnetic data
No power source	Not applicable	Not applicable	Not applicable	Not applicable
Electrical circuits, no wireless	Exempt via approval, certification or notification	Not applicable	Within the exemption wording	Required
Electrical circuits plus Bluetooth or Wi-Fi	Exempt via approval, certification or notification	Not in the exemption wording — separate track	Within the exemption wording	Required

A product with wireless often also picks up cybersecurity review material. One communication function calls three branches at once.

Common mistakes

• Hearing "medical devices are exempt from KC" and not scheduling conformity certification for the wireless module
• Looking for the electrical exemption in the statute, failing to find it and concluding there is none — it is in the Enforcement Rule
• Extending the exemption to the consumer-products track
• Submitting the overseas manufacturer's EMC report and receiving a deficiency because the model name differs (Regulation Article 29(1)7)
• Reading Class 2 as a complete electromagnetic waiver — what is waived is the rationale and measured values, not the report

Pre-application checklist

• Does the product use electrical or electronic circuits? If so, MFDS electromagnetic data is a given
• Does it have a wireless function (Bluetooth, Wi-Fi, NFC)? If so, put conformity certification on its own track
• If a bought-in wireless module is used, confirm its certification status and treatment in the finished product with the supplier
• Check that the model name on the EMC report matches the product in the application
• Reflect in the schedule that the electrical KC exemption arises only after the device approval, certification or notification is in place
• Check the submission scope for your product category directly in Annex 7 of the Approval, Notification and Review Regulation

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Electrical safety and radio are the items regulatory teams discover last, and more so when wireless is involved. How many tracks your product must take, and which report needs to be redone, is what we check first in a free preliminary review.