《医疗器械说明书管理规定》于2001年11月19日经国家药品监督管理局局务会审议通过,现已发布。该规定自2002年5月1日起施行。本文作者依据管理规定对说明书书写要点与注意事项作一简单介绍。1说明书的内容医疗器械说明书应当包含产品能正确使用的全部信息,其内容应当真实、准确 “Medical Device Manual Management Regulations” on November 19, 2001 examined and adopted by the State Drug Administration Bureau has been released. The regulations from May 1, 2002 shall come into force. According to the management rules, the author makes a brief introduction to the key points and precautions of the manual writing. 1 manual content Medical device manual should contain all the information the product can be used correctly, its content should be true and accurate