隨著相關制度的逐步完善，市場環境的逐漸向好，醫療器械或將迎來噴涌爆發式的發展。

新政策要求：醫療器械經營企業要在經營活動中積極應用唯一標識，做好帶碼入庫、出庫，實現產品在流通環節可追溯。

醫療器械經營許可證申請須知

醫療器械經營許可證是醫療器械經營企業必須具備的，開辦第二類醫療器械經營企業，應當向省、自治區、直轄市人民政府藥品監督管理部門備案；

開辦第三類醫療器械經營企業，應當經省、自治區、直轄市人民政府藥品監督管理部門審查批準，并發給《醫療器械經營許可證》。

依據《醫療器械經營監督管理辦法》，開設三類醫療器械運營公司，食品類藥品監督管理局單位將會對經營地開展當場審查。對不符合要求標準的，明確提出整頓規定或未予批準。根據《藥品醫療器械飛行檢查辦法》，食品類藥品監督管理局單位將會對醫療機械銷貨方式合理合法、工作人員在職人員在職、拿貨檢查、運送儲存等層面開展不事先告之的監督管理。三類醫療器械的界定

依據《醫療器械監督管理條例》，第三類醫療器械是具備較高危，必須采用非常對策嚴控管理方法以確保其安全性、合理的醫療機械。例如普遍的注射器、注射針、靜脈留置針、心臟支架、麻醉機、CT、磁共振等。

申請辦理三類醫療器械許可證必須提前準備的原材料

（1）企業營業執照；

（2）公司章；

（3）房屋產權證明、租賃協議；

（4）法定代表人、主要負責人、品質管理員的身份、畢業證等證明材料；

（5）經營地平面設計圖，倉庫平面設計圖。

申請辦理三類醫療器械許可證的規定

（1）場所和倉庫總面積規定：與經營地企業規模相一致。

cts in the circulation link. Instructions for application of medical Device Business License The medical device business license is necessary for the medical device trading enterprise, and the establishment of the second class medical device trading enterprise shall be filed by the drug regulatory department of the people's government of the provincial, autonomous region or municipality directly under the Central Government; The establishment of a class III medical device trading enterprise shall be examined and approved by the drug regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government, and a Medical Device Trading License shall be issued. According to the Measures for Supervision and Administration of Medical Device Operation, the third type of medical device operating company will be established, and the food and Drug Administration will carry out on-the-spot review of the place of operation. For those that do not meet the re, the rectification provisions shall be clearly prescribed or shall not be approved. According to the Measures for Flight Inspection of Drugs and Medical Devices, the Food and Drug Administration will carry out supervision and management of the reasonable and legal sales metho