Korea's Three MDSAP Audit Guidelines — A Door That Opens Both Ways

Key takeaway — On 28 August 2026 the MFDS issued three guidelines on responding to an MDSAP audit. On their face they support Korean manufacturers going abroad. Yet the same MDSAP certificate also shortens the domestic KGMP procedure — it opens a document-review-only route, and the resulting certificate's validity is set equal to that of the MDSAP certificate. One document opens the door in both directions. It is worth confirming from the text, however, that this is a shortened procedure and not an exemption. Compiled in September 2026 from the press reference and the KGMP notification.

1. What was issued

	Content
Date	28 August 2026
Form	Three civil-petitioner guidelines, newly established
Division	MFDS Medical Device Management Division
Where	MFDS website → Legislation and Materials → Legislation Information → Guidance for Officials and Civil Petitioners

The three product types were selected having regard to Korean export performance.

Product type	Class	As described in the press reference
General electrosurgical unit	Class 3	An instrument using high-frequency current for cutting or coagulation
Biomaterial for tissue restoration	Class 4	Biologically derived material used to replace, restore or reconstruct human tissue and organs including vessels, heart, septum, fascia and skin
General ultrasonic diagnostic imaging system	Class 2	A system that transmits ultrasonic energy to the affected area and images the reflected signal for diagnosis

The classes span 2, 3 and 4, and the lines differ. The instrument line (electrosurgical unit, ultrasound system) sits alongside the materials line (biomaterial). A company whose product is not an exact match may still find a comparable line useful.

What the guidelines contain is listed as:

• An overview of the MDSAP audit scheme
• The requirements of MDSAP full member jurisdictions
• Audit characteristics by manufacturing process
• Audit criteria for sterile medical devices
• Quality document templates and worked examples

The press reference adds that items to prepare for audit, taking account of device characteristics such as instruments versus materials and supplies, are also included.

2. The structure — five countries in one audit

The press reference describes MDSAP as an international body created in 2017 for the joint audit of medical device manufacturing and quality management standards. The participants are listed as:

the United States, Canada, Japan, Australia and Brazil

and it states that obtaining MDSAP certification can exempt a manufacturer, wholly or in part, from those countries' GMP certification audits.

One audit carries you through five jurisdictions. For a company preparing several export markets at once, the reduction in audit rounds and document preparation is substantial.

3. But it also changes things at home

This is where the news carries practical weight. The Regulation on Medical Device Manufacturing and Quality Control (MFDS Notification No. 2026-46, in force 1 July 2026) defines MDSAP in Annex 1, item 70:

a scheme under which quality-management-system conformity audit results received from auditing organisations jointly designated and operated by full member jurisdictions such as the United States and Japan are mutually recognised across several countries

And it gives that certificate effect in three places.

Provision	Effect
Article 6(2)6	Where an MDSAP certificate is held, the conformity audit may be conducted by document review alone
Article 7(3)	The submission changes — a copy of the MDSAP certificate and the audit results (including nonconformity reports and corrective and preventive actions), the product standard for the highest-class item in each product group, the five sets of Korean legislation material, and material showing the correspondence between the MDSAP-covered products and the products under audit
Article 9	Where the audit was by document review alone without an on-site inspection, the certificate's validity is set equal to that of the MDSAP certificate

One more. Article 3(2)3(b) addresses a site manufacturing under contract where another operator holds a valid certificate, and requires that, where that certificate was issued by document review without an on-site inspection, an MDSAP certificate (valid and obtained with an on-site inspection) be submitted.

4. A shortened procedure, not an exemption

This is a frequent misunderstanding, so it is worth nailing down. Holding an MDSAP certificate does not make the KGMP conformity recognition procedure disappear. What the notification gives is a document-review route, not a waiver of the audit.

And even on that route there are cases requiring an on-site inspection, in Article 6(3)4.

• Sites due for periodic audit (under Article 4(2))
• Sites where the audit under the joint programme showed major nonconformities such that the MFDS Minister determines public health could be affected
• Combination-product manufacturing sites
• Sites making devices containing human-derived components or using human-derived tissue

In other words, the first audit may go by document review while the periodic audit brings an on-site inspection. A company that does not know this leaves the three-year slot empty and then has no preparation time.

5. Who should be reading this now

Korean manufacturers preparing to export

• If two or more target markets are among the United States, Canada, Japan, Australia and Brazil, MDSAP's value rises sharply
• Read whichever of the three guidelines is closest to your line — instrument, or material and supply
• For a sterile device, the guideline's sterile audit criteria apply directly

Korean importers with an overseas manufacturer

• Check first whether the manufacturer already holds an MDSAP certificate. If so, the shape of KGMP preparation changes
• Put an obligation to provide the MDSAP audit results, including nonconformity reports and corrective and preventive actions, into the agreement. Article 7(3) asks for more than a copy of the certificate
• The correspondence material between MDSAP-covered products and the products under Korean audit cannot be produced in Korea if the manufacturer does not supply it

Manufacturers already running KGMP

• The relationship between an ISO 13485 system and MDSAP is covered in the ISO 13485 and KGMP guide. In short, ISO 13485 makes preparation easier and MDSAP shortens the procedure

Common mistakes

• Reading MDSAP as a KGMP exemption — what the text gives is a document-review route
• Passing the first audit by document review and not anticipating the on-site inspection at the periodic audit (Article 6(3)4)
• Obtaining only a copy of the certificate from the manufacturer and not requesting the audit results and correspondence material
• Not checking whether the MDSAP certificate was obtained with an on-site inspection and remains valid (Article 3(2)3(b))
• Not reflecting in the register that the validity is set equal to the MDSAP certificate (Article 9)

Check now

• Confirm whether two or more MDSAP full member jurisdictions are among your export markets
• Download and read whichever of the three guidelines is closest to your line
• With an overseas manufacturer, confirm whether an MDSAP certificate is held and whether an on-site inspection was involved
• Check whether the agreement obliges provision of the audit results and correspondence material
• If going by document review, put the on-site inspection at the periodic audit into the schedule now
• Record the validity calculation (equal to the MDSAP certificate) in the management register

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MDSAP is a document obtained once and used in several places. It carries value both abroad and in the domestic KGMP procedure, but neither procedure disappears. Whether your site qualifies for the document-review route, and what to secure from your manufacturer, is what we check first in a free preliminary review.