• Journal of Auto-vehicle Safety Association
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• v.12 no.1
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• pp.46-51
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• 2020

Korea is the only country in the world where the regulation of vehicle homologation has been changed from "Type Approval" to "Self-Certification". But there are some regulations that have not been fully changed, so they became double-regulations. In this research, we find out double-regulations in Self-Certification systems focused on "Specification Notice Procedure", and suggest a proposal of amendment to avoid duplication. Through the research, we can reduce unnecessary requirements about homologation, management of vehicle and administrative procedure significantly.

• Journal of the Korea Institute of Information Security & Cryptology
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• v.32 no.2
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• pp.279-287
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• 2022

With the advancement of cyber threats and the development of hacking technologies, cyber security is being emphasized in various fields such as automobiles and ships. According to this trend, various industrial fields are demanding cybersecurity, and related certifications. In this paper, cybersecurity type approval is compared with the RMF stage under the premise that there are common elements with RMF in that cybersecurity elements must be reflected in the entire system development cycle. For comparison, type approval of maritime cyber security of the Korean Register of Shipping was selected. In conclusion, although type approval of maritime cyber security acquisition procedure is not divided by development stage like the RMF, there are the commonalities in the procedure to apply the cybersecurity element to the System development lifecycle like the RMF. Accordingly, the possibility of determining that the cybersecurity element was applied to the entire development cycle was confirmed.

• Journal of the Korean Society for Aeronautical & Space Sciences
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• v.36 no.3
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• pp.298-305
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• 2008

From design to serial production, aircraft should go thorough complicated certification procedure from airworthiness authority such as Type Certificate, Production Certificate and Certificate of Airworthiness. On the other hand, aircraft components are mandated to receive Technical Standard Order Approval and Production Manufacture Approval before commercial use. As domestic aircraft and LRUs are currently under development, Bilateral Aviation Safety Agreement is promoted for the purpose of increasing aviation safety as well as foreign export. This paper describes the basic aircraft certification procedure and compares the difference in the certification system of US and Korea. Thorough this, it is attempted to suggest a requirements for establishing international certification system.

• Journal of Pharmaceutical Investigation
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• v.36 no.6
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• pp.421-435
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• 2006

The objective of this report is to introduce the European Union's variation rules governing medicinal products that are subject to post-approval changes. The EMEA outlines a variety of changes occurring to approved medicinal products. It also recommends a marketing authorisation holder to follow specific post-approval applications in various situations. For instance, the Commission Regulation(EC) No. 1085/2003 explains variation types and suggests post-authorisation procedures with which an applicant should comply. In all cases of minor and major variations the applicant has to investigate and validate whether or not the intended changes would have impact on the safety, efficacy and quality of a drug product. The applicant should then submit to the EMEA a variation application with adequate documentation in support of the notified changes. This procedure is implemented to ensure that changes to the approved medicinal product do not cause my public health concerns. In fact, the post-authorisation guidance categorizes post-approval changes into type IA/IB variations, type II variations, and extension applications. Such classifications determine administrative procedures to be followed in an efficient manner. Based on the type of a variation, the regulatory agency opts to reduce or extend the evaluation time-frame. The thrust of the EU's post-authorisation guidance is introduced in text with appropriate explanation. All these information will be likely to be helpful in updating a Korean regulatory guidance that could better deal with post-approval changes to generic drugs available in the market.

• Journal of Advanced Navigation Technology
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• v.27 no.5
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• pp.621-628
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• 2023

This study derived a reverse engineering procedure for verifying the design identity of original parts and developed parts for PMA(Parts Manufacturer Approval) and STC(Supplemental Type Certificate) of metal brake pads for transport aircraft, which are critical parts among aircraft parts and equipment. In Korea, the regulations for reverse engineering procedures are regulated by the Parts Manufacturer Approval Guidelines, and in the United States, AC No. 21. 303-4. In the reverse engineering for the brake pad, the detailed procedures for each component were determined by selecting verification test items to confirm identity based on sample quantity, dimensional tolerance, mechanical property measurement, material, weight and volume characteristics for each component. In addition, as a result of analyzing the regulation of Korea and United States, in the case of Korea, it is necessary to establish technical standards for braking systems for transport aircraft and regulations related to flight tests.

• Journal of Advanced Navigation Technology
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• v.25 no.3
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• pp.185-193
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• 2021

The system needs to be modified to improve the performance of the aircraft in operation or to satisfy the requirements of related laws. Appropriate standards are required for the technical skills for remodeling the aircraft system, design verification for airworthiness of the aircraft, and supplemental type certification (STC) certification procedures for type certification. This study analyzes the current status and demand of domestic aircraft remodeling, examines the current supplementary type certification procedure, and diagnoses the problem. In addition, as a result of researching measures to improve remodeling technology and certification capabilities to extend the life of the aircraft, improvements in the education system were derived to improve the domestic additional type certification process, such as approval of remodeling agencies and appointment of qualifications for each professional technician.

• Journal of Advanced Navigation Technology
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• v.27 no.6
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• pp.821-827
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• 2023

In this study, the aircraft technical standards of the Korea and the United States were analyzed to derive the dynamometer test procedure required to prove the compatibility for flight test certification of the metal brake pad for transport aircraft. Since the design modification of the brake systems is classified as a major change, the STC(Supplemental Type Certificate) and the PMA(Parts Manufacturer Approval) are required. In accordance with the TSO-C135a, the technical standard order for brake system in the United States, the design landing-stop test, accelerate-stop test, and most severe landing stop test were selected among the test items for flight test. The conditions for the dynamometer test are determined according to the specifications provided by aircraft manufacturer, and the brake pad condition, deceleration, and the number of test are defined according to the TSO-C135a.

• Journal of the Korean Society of Marine Environment & Safety
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• v.26 no.3
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• pp.286-296
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• 2020

Sandwich structures are general-purpose structures that can reduce the structural weight of composite ships. Core materials are essential for these structures, with polyvinyl chloride (PVC) foams being the most popular. These foam core materials are subjected to various tests in the development process, and must satisfy the performance requirements of several ISO and ASTM standards. Therefore, a procedure for evaluating the performance of foam core materials was proposed in this paper. In addition, prototypes were fabricated using a commercial PVC foam core product in accordance with the structural design of an 11 m fiber-reinforced plastic yacht. Then, a case study was conducted on the proposed evaluation procedure. The proposed procedure facilitates the understanding of the performance requirements and evaluation of core materials used in composite ships and is expected to be utilized in developing core materials for marine structures.

• Korean Journal of Clinical Laboratory Science
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• v.53 no.1
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• pp.68-80
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• 2021

An uncertified facility is a facility not certified, as defined in the Biological Agents and Toxins Act (BATA) in Singapore, but has met the requirements of the Ministry of Health to possess First and Fifth Schedule biological agents and toxins. This type of facility is also known as a Biosafety Level 2 Plus (BSL 2+) facility. Registration as an uncertified facility or a BSL 2+ facility requires a certain process and procedure to be sought with the Biosafety Branch of the ministry. This review, shares first-hand knowledge on the journey to achieving registration of the authors' facility. The procedure involved considerable preparation, setting up facility requirements, biosafety precautions, procedures and practices, and training and competence of laboratory users. The ministry conducted a thorough onsite facility audit to ensure that the facility requirements and biosafety procedures and practices were in place. It then issued an approval letter of possession for the first-time use of biological agents and registered the laboratory as an uncertified facility. The expectation is that the comprehensive information shared may be of great benefit to other facilities with similar interests.

• Journal of Auto-vehicle Safety Association
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• v.7 no.4
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• pp.20-25
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• 2015

The basic point of a vehicle recall is to remove vehicle defects as soon as possible and thus prevent possible road traffic accidents caused by the defects beforehand. Therefore, the core of vehicle recall under the self-certification system consists of a timely response and fast remedy of defects. The present study aimed to deduce a plan for improvement of the system necessary for the fast remedy of defects through a phased analysis of defect investigation procedure based on defect investigation statistical data. There will be a need to make the TSB(Technical Service Bulletin) or service campaign data submission of a manufacturer compulsory for the collection of broad defect information in the stage of information analysis and to impose a higher penalty when the manufacturer violates the data submission in the investigation stage. In addition, it is considered that an active service campaign should be induced and a punishment for late recall will be needed for consumer protection.