Last October 20, Qualtech held a two-part webinar themed “Korea Market Expansion and China NMPA Updates.” The guest speaker, Irene Lu, was accompanied by Lily Chang, and three in-house regulatory experts, Sally Kuo, Linda Chiu, and Luna Ho. Together, they shared their expansive knowledge with more than 60 listeners worldwide. 

In the webinar, Qualtech announced its entrance into the Korean market and encouraged other businesses to venture into this bustling and ever-growing country. Important details, such as actionable steps for a successful medical device registration in Korea, were discussed thoroughly. During the second segment, the experts provided a comprehensive summary of the fundamental changes in the Medical Device regulations set by China’s National Medical Products Association from September 2022 to August this year. 

I.    Venturing into South Korea’s Medical Device Market

The webinar began with an overview of the South Korean medical device definition, which is equivalent to the international definition. Based on the country’s authorizing body, the Ministry of Food and Drug Safety (MFDS), formerly known as the Korea Food and Drug Association (KFDA), a medical device is: 

An instrument, machine, apparatus, material, software, or any other similar product specified in the following subparagraphs as one used, alone or in combination, for human beings or animals. 

The Medical Device Act of 2003 (Law No.6909), which regulates all aspects of medical devices in Korea, also states that a medical device is a product used for: 

•	Diagnosing, curing, alleviating, treating, or preventing a disease;
•	Diagnosing, curing, alleviating, or correcting an injury or impairment;
•	Testing, replacing, or transforming a structure or function;
•	Control of conception.

This brief introduction was followed by the key players involved in the life cycle of a medical device: a local or a foreign manufacturer, an importer, and a distributor. Some things to note are:

•	Importers in Korea are known as Medical Device Handlers because they are responsible for the devices produced by foreign manufacturers.
•	A distributor is not only a seller but also a lessor and a repairer of medical devices.

Next, the MFDS categorizes medical device products and classifies risks. In general, there are 26 product groups available for medical devices, including one for software. Also, MFDS classifies risk for medical devices similarly to those in the European Union and Japan. That is, from Class I to IV, with Class IV devices posing the highest risks.

Finally, before entering the Korean medical device market, there are three important documents to take note of: 

1.	Importer License
	Foreign manufacturers must appoint a local importer as an authorized representative. It is crucial to choose one that maintains good communication and provides quality service, such as Qualtech Korea. This entity is responsible for product approval and post-marketing events, such as license recertification and adverse event reporting*. * Note: Foreign manufacturers should immediately notify their importers of any occurrence of an adverse event, whether in or out of Korean jurisdiction.
2.	Korea Good Manufacturing Practice (KGMP) license
	For devices with risk Class II or higher, a KGMP license must be obtained. The requirements are based on the international standard ISO 13485:2016. Moreover, any device must pass an on-site conformity assessment to secure the license. Only a few exemptions, such as scope alterations, qualify for a document review process. The KGMP application process is outlined below. It would take 6 to 8 months to obtain the KGMP license and would need to be renewed every 3 years.
3.	Product Certificate
	To legally market a medical device in Korea, having a product certificate issued by the MFDS is necessary. The application must include a variety of documentation, such as technical data, clinical data, and quality management system (QMS) documentation. Obtaining this certificate is quite straightforward for a Class I medical device. It only needs one day’s work to obtain a pre-market notification. For Class II or higher, the complexity of the process depends on if the device has a significantly equivalent device or if it is a novel medical device. A summary of the process can be found below.
	Lastly, a medical device product certificate would need to be renewed once every 5 years.

If the need to check the applicable standards in Korea arises, refer to the MFDS’ official list here. Note that some standards have additional requirements. For example, the biocompatibility report should be issued by GLP or an OECD GLP Lab.

 

II.    Staying Up-to-date with China’s NMPA Regulations
In the past year, China’s National Medical Products Administration (NMPA) has updated many of its regulations, like those for categorizing medical devices, the list of medical devices exempted from clinical trials, and other more specific laws. 

Pre-Market Approval Regulation Changes
Last July 2023, the NMPA’s Center for Medical Device Evaluation (CMDE) published a new list of medical devices exempted from clinical evaluation. The new list includes 21 new devices, as well as 86 revisions to existing rules related to product name, description, risk classification, and categorization.

Check Circular No.33 2023 for a more in-depth report. 

Additionally, the NMPA made amendments to the Medical Device Classification Catalogue. Such changes include:

•	Adding a specific subcategory into the catalog. For example, the category 01-10 for “Other Surgical Equipment” now contains subcategories like 01-10-06 “Breast Rotary Biopsy System and Accessories.”  This allows for better management of medical products.
•	Upgrading and downgrading some risk categories. For instance, a Soft Tissue Ultrasonic Knife, previously under risk class II, is now a Class III product. Another example would be Guide Wires and Guide Sleeves, which were formerly class III products. With the amendment, they are now classified as Class II medical devices.
•	Including more examples of product names to fit in the catalog. At present, approximately 6700 products are listed to facilitate applicants in easily finding the appropriate classification for their products.

For more information, refer to Circular No. 101 of 2023.

Post-Market Approval Regulation Change
The most important update regarding post-market approval regulations is the changes in the guidelines for verifying the QMS in medical device registration. This includes:

•	Adding new clauses related to GMP, Quality Control, the details of some requirements, and many more.
•	Removing some clauses about outsourcing sample products, the critical points of IVD reagents, and partial production.
•	Modifying some parts of the procurement record, inspection record, and in-process inspection.

Find detailed information in Circular No. 50 of 2022.

Other Essential NMPA Regulatory Changes

•	Full Implementation of Electronic Registration Certificate for Medical Devices
•	Guidelines for the Medical Use of Sodium Hyaluronate
•	Regulations on Enterprises Implementing the Supervision and Management of Responsibilities for Medical Device Quality and Safety
•	Third Batch of UDI Implementation for the Medical Device Product Catalog
•	NMPA on GB 9706.1-2020 and supporting standards, special standards for the implementation of relevant work notice
•	MD QMS Appendix: Medical Device Transportation and Storage Services of Enterprise Quality Management
•	MD QMS Appendix: Specializing in Providing Medical Device Transportation and Storage Services of Enterprise Quality Management On-Site Inspection Guidelines
•	Publication of the List of Mandatory Applicable Standards for Medical Device
•	Electronic Payment for the Product Registration Fee of Drug and Medical Devices
•	Publication of Medical Device Product Registration Dossier Checklist

NMPA Technical Guidance Announced in 2023

128 new technical guidelines were issued from September 2022 to 2023. The purpose is to guide registrants in preparing the registration dossiers, conducting clinical evaluations, and analyzing the risks and benefits of the medical device.

More information can be found here.

Overall, Qualtech has provided a comprehensive overview of the key regulatory requirements for entering the Korean and Chinese medical device markets. It is important to stay up-to-date with the latest regulations, as they are subject to change. With Qualtech’s experienced guidance and support, we can help medical device companies navigate the complex regulatory landscape and ensure that the medical device meets all applicable requirements in the East Asian market. Qualtech’s commitment lies in delivering comprehensive and quality registration services to accelerate market access and catalyze success.

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Lastly, if you have any inquiries or require any assistance regarding Korea and China’s product registration, please feel free to reach out to Ms. Irene Lu (irene@qualtechs.com).