The Ministry of Food and Drug Safety (MFDS), Korea’s national authority responsible for medical device regulation (previously known as Korea Food and Drug Administration or KFDA) issued an update to the requirements regarding the scope of information and documents to be submitted for medical devices.
General Submission Requirements
Medical device application submission requirements are provided by standing regulations on Medical Device Authorization, Notification, and Examination. The provisions of the Regulation cover all issues related to permits, certifications, and notifications regarding medical devices manufactured in South Korea and imported medical devices, implementing requirements regarding the examination of medical device technical documents, application procedures, and the approval process. The regulation also provides definitions for specific elements. For instance, high-tech medical devices are defined as a new medical device based on innovative science and technology, such as biotechnology, information technology, nanotechnology, robot technology, etc. All imported medical devices are subject to approval before being placed on the market. If separate medical devices are combined to be used for the intended purpose, each medical device should be approved separately and the risk class should be defined based on highest risk class among such devices. The regulation provides requirements and rules regarding import, certification and labeling medical device manufacturers should follow in order to obtain marketing authorization allowing to market their products in South Korea. The requirements include, among others, the following:
- If the design and manufacturing processes are carried out in different places, other than the manufacturer`s place of residence, it is necessary to provide manufacturing process flow chart describing each step, including the name and address of each company participating in the manufacturing process;
- Claims on the efficacy for the intended purpose of use should be supported by the appropriate data;
- The information provided in the application should also contain details on raw materials used and specifications of ingredients;
- If a medical device utilizes software, the information should include the name of the software, its version, and operating requirements. It is also necessary to include screenshots showing the way the software operates, and to provide a detailed description of the method of use;
- If the medical device is sterile, the manufacturer shall provide a detailed description of sterilization methods used;
The information on a medical device for certification should also include details on intended use, the principle of operations and raw materials used. The performance of the device should describe physical, mechanical, chemical and electrical characteristics, and also the details on software if applicable. For the imported devices, the information should also include the data on country of origin.
The regulation also provides a set of requirements for the information supplied with the device. If the device is intended to be used by non-professionals, the information supplied with the device should be sufficient to use the device in the manner ensuring safety and effectiveness. Storing and maintenance requirements, safety warnings and restrictions on reuse if applicable should also be included. If the use of the device associated with a high level of risk, the information should contain precautions, including special restrictions on age, gender or health condition. Medical device manufacturer should describe all possible side effects that could be caused by the device. In order to reduce the harm that could be caused by the device, the manufacturer could also include the instruction on treatment applicable in case if such an accident would take place. The description of storing method should include special storage conditions providing that the device would suitable for the intended use. All such information should be provided in a clear and understandable way.
Medical Device Registration Application Review
To ensure high levels of rigorous analysis, the regulating authority implements a set of test standards containing particular requirements to the examinations held to confirm the safety and effectiveness of the device and its performance in the course of the intended purpose. To be cleared for use, the standard should be recognized by the regulating authority. Safety standards depend on the type of the device subject to examination. For example, there are special separate standards applicable for the devices containing electrical elements. The standards impose requirements providing that the examinations should be performed in a way reducing the impact of external factors to increase the accuracy and reliability of the results. In the case of a combined medical device, its elements should be tested both separately and in a whole complex.
According to the Regulation, the registration procedure includes the examination of technical documentation. This type of examination is applicable both for entirely new medical devices that have not been certified earlier and also to the medical devices that are already present at the market after the changes made by the manufacturer. At the same time, some categories of medical devices are exempt from this step, namely:
- Medical devices intended for export (such devices should be marked appropriately: “For export only”);
- Equivalent devices;
- Medical devices identified as identical;
- Medical devices subject to minor changes.
According to the regulation, a step-by-step audit is a screening of data in the form of technical documents necessary for the product application approval.
The scope of data to be provided for examination includes, among others, data on the principle of operations and the intended purpose, the data on applicable standards and comparison to the product already licensed. Safety data includes data on toxicity and biological compatibility.
The regulation also provides the procedure of used device certificate issuance. In this case, the device would be subject to special inspection. The importer or the reseller of the device should also provide information about the medical institution acting as a seller of the device.
The manufacturer should also inform the authority on any substantial changes to the device, its features, and characteristics, including the changes in raw materials used. Such changes could include change of model name due to minor changes, change of the name of the company and change of the address of the manufacturer or its representative. The change report should be submitted within 30 days after the changes take place.
Changes to the Submission Requirements
In order to simplify the registration procedures and make access to the market easier for medical device manufacturers, the regulating authority implemented changes to the submission requirements related to certain categories of medical devices. Once the changes come into force, there would be no obligation to provide Summary Technical Documentation (STED) for the high risk (Class IV) medical devices. Instead, it would be necessary to provide the following information:
- A detailed description of all manufacturing processes (including sterilization, if applicable) and information on standards regulating these processes;
- Description of all processes causing a substantial impact on the performance and effectiveness of the device when used for the intended purpose;
- Visual materials showing all steps of manufacturing processes in the appropriate order.
These new amendments could possibly result in a reduction of time necessary for the manufacturer or the importer to perform all registration procedures and obtain permissions necessary to be able to place the device at the market.
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