South Korea’s Ministry of Food and Drug Safety (MFDS) has issued two guidance dedicated to certain aspects of medical device regulation. One pertains to imported medical devices and the other to scarce and unique devices. These documents had been previously published in the course of public consultations at the end of 2019 and entered into force in January 2020.
South Korea’s Updated Requirements on Imported Medical Devices
The first guidance published by the MFDS explains the exemptions to requirements of imported medical devices. The guidance amends requirements on import business license, import license, import certification and import declaration through making changes to the foreign trade laws. In particular, the document introduces the following standards:
- The packaging and labeling of the device should include the manufacturer and the word “Sterile” (if applicable). If the device is intended solely for the purpose of conducting a study, it should be marked with the “Research and testing” mark. It is also important to mention that, according to the guidance, medical devices intended for research and testing purposes confirm the need for import requirements.
- The information supplied with the devices should include the expiration date and the usage plan. This includes the disposal method after use.
- The party that previously received the importation approval for any of the devices that are exempted from the obligatory importation approval procedures has a right to submit a request for the exemption confirmation requirements.
In order to apply for exemption, the interested party must submit an application to the MFDS indicating the intended purpose of the device. The information on using the device and the way it should be disposed of after use should also be provided with the application. If an applicant confirms that the device would be used solely for research and testing purposes, the MFDS will issue an approval of change of use and recommendation for exemption from imported medical device certification requirements.
To be able to benefit from the aforementioned exemption, the manufacturer has to provide the regulating authority with information on the way the device would be used and describe the research to be conducted using the device. They must also explain the quantity of this type of medical devices reasonably necessary to conduct the research (study). All this information should be provided in the form of a usage plan.
Basically, the guidance on requirements for imported devices implements the importation exemption for medical devices imported for research and testing purposes. It also introduces the procedure of changing the purpose of importation allowing an interested party to make changes necessary to be eligible to utilize the exemption framework.
The scope of the guidance covers all medical devices for which the importer intends to apply for a recommendation for the requirement exemption after the guidance enters into force.
Guidance on Scarce and Urgently Needed Medical Devices
Another guidance published by the MFDS covers the requirements applicable to the supply of scarce and urgently needed medical devices. The document is dedicated to matters related to the demand of rare and urgently needed devices, the details of supply plans for establishments and appropriate submissions, and also to the procedures for applying for the supply of the aforementioned medical devices. The guidance is intended to determine the necessary details and to implement the appropriate provisions regarding the supply and demand surveys.
The company that intends to file an application under the appropriate framework shall provide the authority with the information including a description of procedures for supplying medical devices. At the same time, the authority has a right to require the applicant to provide any additional information reasonably necessary to assess.
The document also provides the following:
- If a scarce or urgently needed medical device is the same as a medical device that has already been licensed, certified or declared, the amount of documents needed to be provided will reduce substantially.
- It may be required to provide references to the particular patient or healthcare institution, medical certificates (indicating product and company names, and also the information about the devices, e.g. model name), and/or covering letters (in a case if the product information is not specified in the certificate).
- An applicant must also describe and explain the reasons for supplying scarce and urgent medical devices.
- Supply agreement should cover the supply quantity, matters concerning supply price and timing, matters concerning billing and payment of supply costs (including late payment interest on late payment) and also any other matters deemed necessary as agreed through consultations held between the authority and the applicant.
- If the authority would determine that it is reasonably necessary to stock up scarce and urgently needed devices in advance, it is entitled to require to perform the appropriate procedure or to conclude a long-term supply agreement.
In accordance with the supplementary provisions of the guidance, all scarce and urgently needed medical devices supplied before the present guidance enters into force should be recognized as devices supplied in accordance with the guidance.
An Application for Supply of Scarce and Urgently Needed Medical Devices
The guidance also contains the application form template. According to the template, the application form should indicate the following information:
- Details about an applicant (name, location, contact person and details),
- Details about the target patient (name, target disease, contact details),
- Details about the product (name, the purpose of use as intended by the manufacturer, quantity, packaging unit, the name of the manufacturer and the country of origin),
- Reasons for applying.
In order to supply scarce and urgently needed medical devices, the manufacturer or any other interested party should submit an application accompanied by the documents listed in the guidance.
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