Technical document review
A technical document review is a general “technical document review” (TDR) for those products that are basically the same as an already approved product, whereas a “safety and efficacy review” (SER) is required for devices unlike those currently available on the market – falling under new structure, new performance, new intended use, and newly developed Medical Devices. Technical documents for all class II Medical Devices are reviewed by 3rd Parties, whereas class III and IV Medical Devices are reviewed by KFDA.
One of the critical aspects of the technical document review is related to the test reports manufacturers already have. Often, manufacturers may think they have all required reports and thus may be ready to submit their technical file. That is not always true. Usually only tests performed at an accredited laboratory will be accepted (see the end of this article for more details). By experience a lot of “bad surprises” could be avoided by including this aspect early in the regulatory/marketing strategy.
General Technical Document Review (TDR)
- Devices substantially equivalent as previously approved products
- Clinical study reports are not required
Safety and Efficacy Review (SER)
- Required for devices with new-to-market features – new developments, new performance, new structure, and/or new intended use
- Significant difference affecting safety and effectiveness
- Clinical study reports are essential, in addition to TDR requirements
Technical Document file contains
- Intended use (IFU)
- Physical, chemical characteristics
- Biological safety
- Electromagnetic compatibility
- Stability report (shelf-life test)
- Principle of operation
- Electrical, mechanical safety
- Irradiation safety
In addition to TDR, SER requires:
- Original developer
- Clinical investigation data
- Design history and background
- Market history in foreign countries
In the product registration procedure, the class II Medical Devices defined as “equivalency-notified products” are exempt from technical document review process, and those defined as “modified products” are partially exempt.
What is a “equivalency-notified product”?
- Medical Devices, which are equivalent to premarketed devices for the intended use, operation principle or used materials (for non-active Medical Devices), performance, test specification and operation method, etc.
- Equivalency-notified and regularly updated by KFDA
- Test report required to identify the “equivalency” issued
- by KFDA-registered test laboratories
Medical Device testing
The test reports issued by the following laboratories are recognized to support the function, safety and effectiveness
- KFDA-registered laboratories
- IEC-registered laboratories (CBTL)
- KOLAS-accredited laboratories (Korea Laboratory Accreditation Scheme acc. to ISO 17025)
- GLP laboratories accredited according to OECD rules