KCL 한국건설생활환경시험연구원 Korea Conformity Laboratories

식품의약품안전처로부터 의료기기 품질관리 심사기관으로 지정 받아 의료기기 전 품목군(26개)에 대한 의료기기 제조 및 수입업체의 품질관리를 위한 인증평가 (GMP 마크) 업무를 수행하고 있습니다. 품질관리 심사 대상 의료기기를 제조 또는 수입하는 경우 임상시험용 의료기기를 제조하는 경우 품질관리 심사 대상 최초심사 제조 또는 수입 의료기기가 이 기준에 적합함을 인정받기위해 최초로 받아야 하는 심사 정기심사 최초심사 후 3년 주기로 실시하는 사후 관리 심사 (유효기간 만료일 3개월 전까지 이전에 신청하여야 함.) 추가심사 별표 3에 따른 다른 품목군의 의료기기를 추가하는 경우 새로이 받아야 하는 심사 지원내용 제조소의 소재지 변경에 따라 적합성평가를 새로이 받아야 하는 심사. 다만, 제품의 품질과 관계가 적은 보관소, 시험실의 변경은 제외 업무절차 업무절차 : 신청자가 심사기관에 적합인정업무 상담 요청 > 심사기관에서 적합인정업무 상담 > 신청서 검토 > 보완 필요시 보완서류 요청 및 보완조치 > 적합인정 신청 > 신청 접수 > 심사기관에서 각 지방 식품의약안전청에 의료기기 감시원 선정요청 > 식품의약안정청에서 심사기관에 의료기기 감시원 및 심사일 통보 > 심사기관에서 신청인에게 심사계획 통보 > 신청인은 심사 준비 > 심사준비 완료 후 서류 검토 및 현장조사 실시 > 부적합시 보완요구 > 신청인이 보완사항 시정 및 보완심사 신청 > 적합시 각 지방식품의약품안전청에 적합인정서 발행 >
식품의약품안정청에서 심사결과 및 심사실적 관리, 신청인은 적합인정서 판매 블로그 KCL 공식 블로그

As a GLP(Good Laboratory Practice) testing institution for human pharmaceuticals and medical devices, we are accumulating rich testing capabilities based on advanced equipment. We support permits and certifications for medical devices, chemical substances, pharmaceuticals, and pesticides, and conduct biological safety evaluations using animals, microorganisms, cells, and other methods, ranging from medical device testing to biological safety assessments. Overview Testing & Inspection of Medical Devices (Biological Safety Testing for GLP Compliance) Full Range of Biological Safety Testing Services for GLP Compliance of Medical Devices Issue final GLP report in accordance with the respective testing standards for approval on medical device items Common standards on the biological safety of medical devices ISO 10993 testing(certain items excluded) Reference standard of medical device Overseas standards(USP, ASTM), etc GLP test-related items of medical devices In vitro/in vivo genotoxicity test Cytotoxicity test, blood compatibility test, endotoxin test Irritation test, skin sensitization test, pyrogen test Transplantation test and systemic toxicity test(subacute/subchronic toxicity & acute systemic toxicity test) Testing & Inspection of Medical Devices (Performance/Safety Assessment) Testing and Inspection Services Covering All 16 Categories of Medical Device & Full Technical Support at Every Stage of Product Development and Quality Control Testing and inspection of medical devices for approval and certification Coverage of all 16 medical device categories including surgical equipment and instruments, medical equipment for external/internal insertion, and dental equipment and instruments Assessment of the physical and chemical properties and performance of dental materials Commissioned testing and quality inspection of medical devices Validation of cle aning, sterilization, packaging, cleanliness, etc. Testing of bio-burdens, microbial limits, etc Assessment of the R&D on Medical Device Testing and assessment of research projects, support for new project development, and testing and assessment for overseas certifications Assessment of the safety and performance of medical devices produced by 3D printing; support for R&D Assessment for development and quality control of medical devices using new technology; support for R&D of medical devices using new technology Non-clinical Safety Assessment for GLP Compliance & Validation of Bio-materials Assessment of the Safety of Pharmaceuticals, Agrochemicals, Chemicals, etc. that can be Harmful to Human or Environment, and Assessment and R&D of the Safety of Veterinary Pharmaceuticals and Devices Non-clinical safety assessment for GLP compliance Pharmaceuticals: General toxicity(incl. toxicokinetics), inhalation toxicity, genotoxicity, irritation, skin sensitization, etc. Chemicals: General toxicity, inhalation toxicity, irritation, corrosion, skin sensitization, ecotoxicity, etc Pesticide: Oral/dermal toxicity, irritation, skin sensitization, ecotoxicity, pesticide residual test, etc. Veterinary pharmaceuticals and devices: Cytotoxicity, irritation, skin sensitization, transplantation, etc. Validation of Bio-materials Efficacy assessment: Pharmaceuticals, health foods, functional foods, medical devices, functional cosmetics, etc. Pharmacokinetics testing: Analysis of pharmacokinetics using animal specimens; analysis of bioequivalence and metabolites in biological specimens Clinical and histopathological testing: Preparation and microscopic examination of slides; hematological, biochemical, and immunological testing Bio-product consulting: Technical support and joint R&D for commercialization of bio-materials Quality Control Audit of Medical Devices for GMP Conduct GMP Audit on All Medical Device Items of Domestic and Foreign Medical Device Manufacturers Entity: Manufacturers and importers of medical devices Subject: All medical device items of Grade 2 to 4(Grade 2: Assessment by a sole quality control assessor; Grade 3 to 4: Joint assessment with a regional food and drug safety authority) Type Initial audit: Initial audit to recognize the compliance with quality control requirements Regular audit: Recurring audit(at least once every 3 year) Change audit: In case the location of manufacturing facility is changed (change in the location of storage facilities or laboratories are not considered) Additional audit: In case that a medical device from a different category is added to the manufacturing facility Microorganisms, viruses, bioaerosols, & insect-repellent fields Sterilization, antibacterial, & antifungal testing Antiviral testing Bioaerosol reduction performance testing Performance testing of air purifying products such as air purifiers, air sterilizers, HVAC, & filters for reducing airborne microorganisms(airborne viruses, airborne bacteria, & airborne mold) Biocide effect/efficacy testing Evaluation of effectiveness/efficacy for approval of biocides according to the Consumer Chemical Products & Biocides Safety Control Act Testing of space surface disinfection efficacy/performance Evaluation of space surface disinfection performance of space disinfection products such as disinfectants & liquid disinfectants Insect repellent/insecticide performance evaluation testing Checking insect repellent rate and insecticidal power of materials & products Microbial identification & genetic analysis research Measurement and analysis of microbial(bacterial, mold, & viral) contamination in the field(field test) Audit of Technical Documentation on Medical Devices Audit the technical documentation for Grade 2 medical device certification Supplies(5 categories) Cardiovascular equipment and instruments, surgical instruments, vision correction lenses, pharmaceutical injectors, dental materials Electronics(9 categories) Medical tables, radiation treatment devices, physical treatment devices, cardiovascular equipment and instruments, biological condition measuring devices, medical magnetic generators, surgical instruments, vision correction lenses, pharmaceutical injectors In vitro diagnosis(1 category) In vitro diagnosis Medical Technology Support Provide support for advance consulting of physical/chemical properties assessments, performance testing, biological safety testing, etc. for the medical device approval and audit Ongoing training and management of members depending on whether they are VIP or new members Specialized consulting on medical devices and their commercialization; prompt response Support to customized training according to the characteristics of medical devices Proposal and development of domestic and international standards, including ISO and KS

식약처 및 의료기기 심사기관 월례회의 결과 입니다.(~'23.09까지)

1. 의료기기 제조 및 품질관리 기준 고시(식품의약품안전처 고시 제2023-79호(2023.12.19 개정)) 2. MDSAP 심사결과 활용 가이드라인 [민원인 안내서] (2024.02)3. 의료기기 GMP 종합 해설서(민원인 안내서) (제8개정)4. 의료기기 제조 및 품질관리기준(GMP) 심사 사례집 (2023.11)5. 의료기기 제조 및 품질관리기준(GMP) 운영 기본 지침 [공무원 지침서] (2023.10)6. 의료기기 GMP 적합성인정 심사 신청 안내서 - 제조소 작성방법 - (2023.06)