Medical devices exempt from SCCSR

Just as in many countries, premarket approval is required for importing medical devices to Korea.  The premarket approval is classified into notification, certification, and approval depending on the class of a medical device and the requirement of clinical test. Outline of the premarket approval process is well explained in the webpage of the competent authority, MFDS (Ministry of Food and Drug Safety):  https://www.mfds.go.kr/mfds/eng/html/sub04/MFDS-DE01-10-26-L0001.jsp

Apart from the premarket approval, as prescribed in the CONSOLIDATED PUBLICE NOTICE (통합공고), a document called “표준통관예정보고서 (SCCSR: Standard Customs Clearance Schedule Report)” shall be submitted to the KMDIA (Korea Medical Devices Industry Association) to import medical devices. In relation to the HS Codes where medical devices can be classified, SCCSR is designated to be checked by a customs officer during the import customs clearance under the NOTIFICATION ON DESIGNATION OF GOODS SUBJECT TO VERIFICATION BY HEAD OF CUSTOMS AND VERIFICATION METHOD IN ACCORDANCE WITH ARTICLE 226 OF THE CUSTOMS ACT (관세법 제226조에 따른 세관장확인물품 및 확인방법 지정고시).

 

Through SCCSR, shipment details like information of importer, exporter, and manufacturer, total amount, settlement currency, terms of payment, terms of delivery, port of discharge, medical device class, product name, product code, approval number, quantity, unit price, etc. are reported.

 

KMDIA levies following fees for processing SCCSR:

Classification	Basic fee	Unit fee	Remark
Member	KRW 5,000 per SCCSR	KRW 0.4/USD	If the total amount doesn’t exceed USD 10,000 per SCCSR, apply the basic fee. If the total amount exceeds USD 10,000 per SCCSR, apply the basic fee and unit fee.
Non-member		KRW 0.5/USD

The fee can be a burden for importers of medical devices. In order to lessen the burden, MFDS decided to make the Software as a Medical Device (SaMD) exempt from SCCSR.

 

In the IMDRF/SaMD WG/N10FINAL:2013, SaMD is defined as software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device. In the MFDS Notification, REGULATIONS FOR PRODUCT CLASSIFICATION OF MEDICAL DEVICE AND CLASS BY PRODUCT (의료기기 품목 및 품목별 등급에 관한 규정), SaMD is classified as follows:

(E) Software as a Medical Device
	E01000 Software for cardiovascular
	E01010.01	[2]	Cardiovascular image, treatment planning software
	E01010.02	[2]	Cardiovascular image, analysis software
	E01020.01	[2]	Electrocardiograph, analysis software
	E01020.02	[2]	Electrocardiograph, mobile analysis software
	E01030.01	[2]	Blood flow, analysis software
	E01040.01	[2]	Cardiac output, analysis software
	E01050.01	[2]	Oxygen saturation, analysis software
	E01050.02	[2]	Oxygen saturation, mobile analysis software
	E01060.01	[2]	Blood gas, analysis software
	E01070.01	[2]	Blood pressure, analysis software
	E01070.02	[2]	Blood pressure, mobile analysis software
	E01080.01	[2]	Heart rate, analysis software
	E01080.02	[2]	Heart rate, mobile analysis software
	E01090.01	[2]	Pulse wave, analysis software
	E01090.02	[2]	Pulse wave, mobile analysis software
	E01100.01	[3]	Cardiopulmonary physiology, analysis software
	E01110.01	[3]	Cardiovascular risk assessment software
	E01120.01	[3]	Cardiovascular image, computer aided detection/diagnosis software
	E02000 Software for dental
	E02010.01	[1]	Dental image, Picture archiving and communication system, software, class 1
	E02010.02	[2]	Dental image, Picture archiving and communication system, software, class 2
	E02020.01	[2]	Dental image, treatment planning software
	E02020.02	[2]	Dental image, analysis software
	E02030.01	[2]	Dental image, computer aided detection/diagnosis software
	E03000 Software for otolaryngology
	E03010.01	[2]	Audiometer software
	E03020.01	[2]	Evoked-response audiometer, analysis software
	E03030.01	[2]	Impedance audiometer, analysis software
	E03040.01	[2]	Equilibrium function, analysis software
	E03050.01	[2]	Larynx function, analysis software
	E04000 Software for gastroenterology and urology
	E04010.01	[2]	Endoscopic image, treatment planning software
	E04010.02	[2]	Endoscopic image, analysis software
	E04020.01	[2]	Endoscopic image, computer aided detection/diagnosis software
	E04020.02	[3]	Gastric cancer image, computer aided detection/diagnosis software
	E04020.03	[3]	Colorectal cancer image, computer aided detection/diagnosis software
	E04020.04	[3]	Prostate cancer image, computer aided detection/diagnosis software
	E05000 Software for general hospital
	E05010.01	[2]	Infusion safety management software
	E05020.01	[2]	Vital sign, analysis software
	E05020.02	[2]	Polysomnograph, vital sign, analysis software
	E05030.01	[2]	Bone absorptiometric ultrasound, analysis software
	E05040.01	[2]	Ultrasound image, treatment planning software
	E05040.02	[2]	Ultrasound image, analysis software
	E05050.01	[2]	Ultrasound image, computer aided detection/diagnosis software, class 2
	E05050.02	[3]	Ultrasound image, computer aided detection/diagnosis software, class 3
	E05060.01	[2]	Near infrared camera image, analysis software
	E05070.01	[2]	Wound image, analysis software
	E05080.01	[2]	Lungcapacity, analysis software
	E05080.02	[2]	Pulmonary exercise stress, analysis software
	E05090.01	[2]	Respiratory gas, analysis software
	E05090.02	[2]	Respiratory function, analysis software
	E05090.03	[2]	Respiratory resistance, analysis software
	E05090.04	[2]	Respiratory mobile analysis software
	E05100.01	[2]	Body temperature, mobile analysis software
	E05110.01	[1]	U-healthcare gateway software, class 1
	E05110.02	[2]	U-healthcare gateway software, class 2
	E05110.03	[3]	U-healthcare, decision support software
	E06000 Software for neurology
	E06010.01	[2]	Electroencephalograph, analysis software
	E06010.02	[2]	Magnetoencephalograph, analysis software
	E06020.01	[2]	Neural image, treatment planning software
	E06020.02	[2]	Neural image, analysis software
	E06030.01	[2]	Ataxiagraph, analysis software
	E06040.01	[2]	Parkinson’s disease exercise aided software
	E06050.01	[2]	Psychological assessment software
	E06060.01	[2]	Cognitive assessment software
	E06060.02	[2]	Cognitive therapy software
	E06070.01	[2]	Affective disorder therapy software
	E06080.01	[2]	Evoked response, analysis software
	E06090.01	[3]	Neural image, computer aided detection/diagnosis software
	E07000 Software for uterology
	E07010.01	[2]	Fertility, computer aided diagnosis software
	E07020.01	[2]	Vital sign fetal, analysis software
	E07020.02	[2]	Ultrasonic fetal heart, analysis software
	E07030.01	[3]	Congenital defect risk assessment software
	E08000 Software for ophthalmology
	E08010.01	[2]	Ophthalmic image, treatment planning software
	E08010.02	[2]	Ophthalmic image, analysis software
	E08020.01	[3]	Ophthalmic image, computer aided detection/diagnosis software
	E08030.01	[2]	Vision training software
	E09000 Software for orthopaedics
	E09010.01	[2]	Orthopaedic image, treatment planning software
	E09010.02	[2]	Orthopaedic image, analysis software
	E09020.01	[2]	Orthopaedic image, computer aided detection/diagnosis software
	E10000 Software for rehabilitation
	E10010.01	[2]	Electromyograph, analysis software
	E10020.01	[2]	Respiratory rehabilitation, software
	E10020.02	[3]	Cardiopulmonary rehabilitation software
	E11000 Software for radiation oncology and diagnostic radiology
	E11010.01	[1]	Medical image, mobile picture archiving and communication system, software
	E11010.02	[1]	Medical image, picture archiving and communication system, software, class 1
	E11010.03	[2]	Medical image, picture archiving and communication system, software, class 2
	E11020.01	[2]	Medical image, treatment planning software
	E11020.02	[2]	Medical image, analysis software
	E11020.03	[2]	Medical image, radiation treatment planning software
	E11030.01	[2]	Medical image, computer aided detection/diagnosis software, class 2
	E11030.02	[3]	Medical image, computer aided detection/diagnosis software, class 3
	E11030.03	[3]	Breast cancer image, computer aided detection/diagnosis software
	E11040.01	[3]	Cancer risk assessment software

 

SaMD was first inserted in the REGULATIONS FOR PRODUCT CLASSIFICATION OF MEDICAL DEVICE AND CLASS BY PRODUCT through the MFDS Notification No. 2020-103 (Oct. 26, 2020) and SCCSR exemption for SaMD was reflected in the CONSOLIDATED PUBLICE NOTICE through the MOTIE Notification No. 2020-212 (Dec. 10, 2020).

 

Previously, SaMD was included in the premarket approval as a component of a medical device. From Oct. 26, 2020, a separate premarket approval is issued for SaMD with its E00000.00 classification number indicated.

 

Pursuant to Article3 (1) of ADDENDA of the MFDS Notification No. 2020-103, the classification number, item name, definition, and class of a SaMD which has already been approved, certified, or notified is deemed as changed without undergoing the procedure for change. So, if a medical device is SaMD, SCCSR is not required regardless of its indication in the premarket approval.

 

Notwithstanding, it shall be noted that software whose intended purpose is to drive a hardware medical device does not meet the definition of SaMD.