Manufacturing and Import Business Licences under the Korean Medical Device Act

1. Key takeaways

The first step of the Korean medical device business is not filing a product but obtaining a business licence. The Medical Device Act sets two licences by business form: the licence for manufacturing business (Article 6) and the licence for import business (Article 15). Only the holders of these two licences can proceed to apply for item licences, item certification or item notification.

Facility requirements differ by business form. Manufacturing requires a manufacturing site, laboratory and storage facilities, plus a quality manager; importing requires a business premises, storage facilities and quality inspection facilities, likewise with a quality manager. Both must have a quality manager, which is the common element.

For Chinese manufacturers entering the Korean market, the route is the import business licence: a licensed entity in Korea (KLH) holds the import business licence and the import item licences, the manufacturing site remains offshore, and its quality system is confirmed through the KGMP conformity audit. GRZAN advises treating the question of whether the facilities and personnel of the licensed entity continuously meet the statutory conditions as an annual review item, not as a one-time check at application.

2. Legal basis

The two business licences and their statutory conditions rest on the following instruments.

Comparison of the statutory conditions of the two business licences (supplementary table)

3. Expert insights

Insight 1: The business licence and the item licence are two levels of licence and must not be merged into one concept.

The business licence answers whether the business may be conducted at all; the item licence, certification or notification answers whether this product may be sold. What GRZAN has encountered in projects is a company that treated the two as a single application and prepared documents along the item dimension, only to find the file not accepted because the conditions of the business licence were unmet. The sequence of the two levels is fixed: business licence first, item licence afterwards.

Insight 2: The quality inspection facilities of the import business licence are often underestimated.

The holder of an import business licence must have quality inspection facilities and equipment for inspecting imported products. A holder with only a warehouse and office space will be required to supplement them in the licence review. GRZAN advises verifying these three items on site when selecting a licensed entity, rather than reading only the business scope on the registration certificate.

Insight 3: Offshore manufacturing sites connect through the KGMP audit, with the certificate valid 3 years.

For Chinese manufacturers the manufacturing site is offshore, and its quality system is confirmed through the KGMP conformity audit (MFDS Notification No. 2023-79), with the certificate valid 3 years. The KGMP and the import business licence belong to two separate systems, yet the lapse of either one affects the actual conduct of the import business.

Insight 4: The business licence also sits inside the item renewal system.

Article 49 of the Medical Device Act, as amended by Act No. 17248 with effect from 8 October 2020, requires manufacturing licences, manufacturing certifications, manufacturing notifications, import licences, import certifications and import notifications to be renewed every 5 years. Obtaining the business licence is not once and for all; it must be managed on a compliance calendar.

4. Practical recommendations

• Verify the business licence before touching the item documents. GRZAN advises confirming at the project kick-off meeting that the licensed entity’s import business licence is within its validity and that the facilities and the quality manager are in place.
• Verify the three hardware items on site. Photograph and archive the business premises, the storage facilities and the quality inspection facilities and equipment item by item, as evidence for licence maintenance.
• Merge the KGMP and business licence validity onto one calendar. The KGMP certificate is valid 3 years and items must be renewed every 5 years; the two cycles are not synchronised and managing them separately easily misses items.
• Write the quality manager arrangement into the contract terms. Agree with the licensed entity on the presence-in-post of the quality manager and the duty to notify of changes, so that personnel turnover does not undermine the licence conditions.
• Report changes promptly. Relocation of the business premises and adjustment of storage facilities are licence matters; changing them without reporting creates compliance risk.

5. Verification checklist

• □ Type of business licence: confirm a manufacturing licence or an import business licence; matched to the actual business form.
• □ Premises conditions: verify the business premises or manufacturing site on site; identical to the licence registration.
• □ Facility conditions: check the storage facilities and the quality inspection facilities and equipment; the equipment list is complete and usable.
• □ Quality manager in post: check the employment certificate and the registration information; full-time, in post and registered.
• □ KGMP status: check the certificate validity period; valid for 3 years and not expired.
• □ Item renewal cycle: check the date of the last renewal; renewal completed within the 5-year cycle.
• □ Change reporting: check the records of premises and facility changes; reported after each change.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, Korean licence holder and local testing support for the Republic of Korea. Our team manages MFDS premarket approvals and KGMP conformity, coordinates import requirements, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com