html 소스복사 <p><span style="font-size: 10pt;">제1차 의료기기산업 실태조사</span></p> <p><span style="font-size: 10pt;"><br></span></p> <p><span style="font-size: 10pt;">목 차</span></p> <p><span style="font-size: 10pt;">1장 조사 개요</span></p> <p><span style="font-size: 10pt;">제1절 추진 배경 및 목적</span></p> <p><span style="font-size: 10pt;">1. 조사배경 및 목적···································································10</span></p> <p><span style="font-size: 10pt;">추진배경············································································10</span></p> <p><span style="font-size: 10pt;">법적근거············································································10</span></p> <p><span style="font-size: 10pt;">2. 조사 대상··············································································11</span></p> <p><span style="font-size: 10pt;">조사항목 및 범위···································································11</span></p> <p><span style="font-size: 10pt;"><br></span></p> <p><span style="font-size: 10pt;">2장 조사 결과</span></p> <p><span style="font-size: 10pt;">제1절 의료기기 규제 및 정책 동향</span></p> <p><span style="font-size: 10pt;">1. 국내 의료기기산업 규제 및 주요 정책········································· 15</span></p> <p><span style="font-size: 10pt;">규제제도············································································ 15</span></p> <p><span style="font-size: 10pt;">산업 육성정책······································································ 16</span></p> <p><span style="font-size: 10pt;">2. 해외 의료기기산업 규제 및 주요 정책········································ 17</span></p> <p><span style="font-size: 10pt;">국가별 혁신의료기기 지정 제도··············································· 19</span></p> <p><span style="font-size: 10pt;">3. 국가별 혁신의료기기 관리 제도················································ 19</span></p> <p><span style="font-size: 10pt;">국가별 혁신의료기기 지정 및 허가 현황··································· 20</span></p> <p><span style="font-size: 10pt;">제2절 의료기기 산업 및 시장 현황</span></p> <p><span style="font-size: 10pt;">1. 글로벌 의료기기 산업 및 시장 현황··········································· 26</span></p> <p><span style="font-size: 10pt;">글로벌 의료기기 시장 규모···················································· 26</span></p> <p><span style="font-size: 10pt;">글로벌 의료기기 수출·입 규모················································ 28</span></p> <p><span style="font-size: 10pt;">글로벌 의료기기 주요 기업···················································· 30</span></p> <p><span style="font-size: 10pt;">글로벌 의료기기산업 투자 및 인수합병·····································3 1</span></p> <p><span style="font-size: 10pt;">2. 국내 의료기기 산업 및 시장 현황··············································35</span></p> <p><span style="font-size: 10pt;">국내 의료기기 산업 규모························································35</span></p> <p><span style="font-size: 10pt;">국내 의료기기 기업 현황······················································· 39</span></p> <p><span style="font-size: 10pt;">국내 의료기기산업 인력 현황················································· 43</span></p> <p><span style="font-size: 10pt;">3. 국내 의료기기 사용 현황························································ 46</span></p> <p><span style="font-size: 10pt;">의료기관 종별 국산의료기기 사용 현황····································· 46</span></p> <p><span style="font-size: 10pt;">제품 분류별 국산의료기기 사용 현황········································ 48</span></p> <p><span style="font-size: 10pt;">의료기관 종별 주요 보유 제품 및 국산의료기기 사용 현황············· 51</span></p> <p><span style="font-size: 10pt;">제3절 의료기기 연구개발 및 기술(제품) 현황</span></p> <p><span style="font-size: 10pt;">1. 국가연구개발 투자 현황··························································54</span></p> <p><span style="font-size: 10pt;">의료기기 국가연구개발 투자 규모············································54</span></p> <p><span style="font-size: 10pt;">분야별 의료기기 국가연구개발 투자 규모 ··································57</span></p> <p><span style="font-size: 10pt;">2. 의료기기 임상시험 현황··························································58</span></p> <p><span style="font-size: 10pt;">의료기기 임상시험기관 현황···················································58</span></p> <p><span style="font-size: 10pt;">의료기기 임상시험계획 승인 현황············································59</span></p> <p><span style="font-size: 10pt;">분야별 의료기기 임상시험계획 승인 현황···································59</span></p> <p><span style="font-size: 10pt;">3. 국가별 의료기기 기술 경쟁력·················································· 60</span></p> <p><span style="font-size: 10pt;">의료기기 분야별 기술 수준····················································· 61</span></p> <p><span style="font-size: 10pt;">의료기기 분야별 기술 성숙도··················································62</span></p> <p><span style="font-size: 10pt;">4. 의료기기 제품화 현황·····························································65</span></p> <p><span style="font-size: 10pt;">의료기기 신규 신고·인증·허가 현황··········································65</span></p> <p><span style="font-size: 10pt;">분야별 의료기기 신규 신고·인증·허가 제품·································67</span></p> <p><span style="font-size: 10pt;"><br></span></p> <p><span style="font-size: 10pt;">3장 기업 실태조사</span></p> <p><span style="font-size: 10pt;">1. 일반 현황·············································································72</span></p> <p><span style="font-size: 10pt;">기업 유형 및 업종 분류···························································72</span></p> <p><span style="font-size: 10pt;">2. 인력 현황 ············································································74</span></p> <p><span style="font-size: 10pt;">직무별 인력 분포··································································74</span></p> <p><span style="font-size: 10pt;">3. 연구개발 및 제조 현황····························································78</span></p> <p><span style="font-size: 10pt;">연구개발 수행······································································78</span></p> <p><span style="font-size: 10pt;">연구개발비········································································· 80</span></p> <p><span style="font-size: 10pt;">제품 개발 건수 및 기간···························································81</span></p> <p><span style="font-size: 10pt;">제조 주체 및 원자재 수급······················································· 82</span></p> <p><span style="font-size: 10pt;">외부협력 수행(연구, 제조, 마케팅 분야 전체)····························· 84</span></p> <p><span style="font-size: 10pt;">4. 시장진출 현황······································································ 86</span></p> <p><span style="font-size: 10pt;">의료기기 기업 매출 총액(추정)··············································· 86</span></p> <p><span style="font-size: 10pt;">국내 주요 유통 판매처···························································87</span></p> <p><span style="font-size: 10pt;">해외 법인 설립···································································· 88</span></p> <p><span style="font-size: 10pt;"><br></span></p> <p><span style="font-size: 10pt;">4장 참고 자료</span></p> <p><span style="font-size: 10pt;">1. 정책 의료기기산업 8대 중점 분야에 따른 산업 분류체계 ···············92</span></p> <p><span style="font-size: 10pt;">요약···················································································92</span></p> <p><span style="font-size: 10pt;">세부 내용 ···········································································92</span></p> <p><span style="font-size: 10pt;">2. 국가과학기술표준분류와 8대 분야 중점 의료기기산업 분류체계 매칭············································ 94</span></p> <p><span style="font-size: 10pt;"></span></p>
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