ÔÚ¹ýÈ¥µÄ¼¸ÄêÀ°ÍÎ÷µÄÒ½ÁÆÆ÷е²úÒµ²»¶Ï·¢Õ¹£¬ÒѾ³ÉΪÁËÀ¶¡ÃÀÖÞ×î´óµÄÒ½ÁÆÆ÷еÊг¡¡£¶ÔÓÚ³ö¿ÚÉÌÀ´Ëµ£¬Á˽â°ÍÎ÷Ò½ÁÆÆ÷еµÄ×¼Èë·¨¹æÖÁ¹ØÖØÒª¡£±¾ÎÄÖ÷Òª´Ó°ÍÎ÷Ò½ÁÆÆ÷еÁ¢·¨»ú¹¹¡¢Ò½ÁÆÆ÷еµÄ·ÖÀ࣬ÒÔ¼°Ò½ÁÆÆ÷е²úÆ·µÄÊг¡×¼ÈëµÈ·½Ãæ½øÐÐÉîÈëÆÊÎö¡£
°ÍÎ÷Ò½ÁÆÆ÷е¼à¹ÜµÄ»ù±¾·¨¹æÊÇRDC185/01¡£¸Ã·¨¹æÓɹú¼ÒÎÀÉú¼à¶½¾Ö£¨ANVISA£©¸ºÔðÖ´ÐС£ANVISAÊÇ°ÍÎ÷µÄÖ÷Òª¼à¹Ü»ú¹¹£¬¸ºÔðÉóÅúºÍ¼à¶½Ò½ÁƲúÆ·µÄÊг¡×¼Èë¡£
ÔÚ°ÍÎ÷£¬Ò½ÁÆÆ÷е°´ÕÕ·çÏյȼ¶±»·ÖÀàΪËĸö¼¶±ð£¬·Ö±ðÊÇ¢ñ¡¢¢ò¡¢¢ó ºÍ¢ôÀà¡£¢ñÀà´ú±í×îµÍ·çÏÕ£¬¶ø¢ôÀà´ú±í×î¸ß·çÏÕ¡£Ò½ÁÆÆ÷еµÄ·ÖÀà¹æÔòÔÚRDC185·¨¹æµÄ¸½Â¼IIÖÐÓÐÏêϸ¹æ¶¨¡£
°ÍÎ÷¶ÔÓÚÈκÎÉæ¼°ÈËÌåµÄ²úÆ·£¨°üÀ¨Ò©Æ·¡¢Ò½ÁÆÆ÷е¡¢ÃÀÈÝ»¯×±Æ·µÈ£©µÄ¾Óª¶¼ÓÐÑϸñµÄ¹æ¶¨¡£³ö¿ÚÉÌÔÚÏúÊÛÕâЩ²úÆ·Ç°£¬±ØÐëÏò°ÍÎ÷ÎÀÉú²¿Ìá½»ÊéÃæÉêÇ룬²¢Í¨¹ý¹Ù·½Ö¸¶¨µÄ×¢²á³ÖÖ¤ÈËÌṩע²á²ÄÁÏ¡£ÕâЩ²ÄÁϱØÐëÒÔÆÏÌÑÑÀÓïΪÖ÷ÒªÓïÑÔ¡£
¾ßÓж¯Á¦Ô´µÄÒ½ÁÆÆ÷е²úÆ·ÐèҪͨ¹ýÈÏÖ¤¡£ÈÏÖ¤¹ý³ÌÓɵÚÈý·½»ú¹¹Ö´ÐУ¬Æ佫¶Ô²úÆ·½øÐмì²â£¬²¢¶ÔÉú²ú¹¤³§½øÐÐÉóºË¡£¶ÔÓÚ·çÏսϸߵÄIIIÀàºÍIVÀàÒ½ÁÆÆ÷е£¬ÖÆÔìÉÌ¿ÉÒÔÑ¡ÔñʹÓÃMDSAP£¨Ò½ÁÆÆ÷еµ¥Ò»ÉóºË³ÌÐò£©ÉóºËÀ´Ìæ´úANVISAµÄÉóºË¡£ÖµµÃ×¢ÒâµÄÊÇ£¬°ÍÎ÷Ä¿Ç°ÒѾ¹«²¼ÁË11¼Ò»ñµÃÊÚȨµÄMDSAP¼ì²â»ú¹¹¡£
£¨1£©Ê²Ã´ÊÇMDSAP
MDSAPÈ«³ÆMedical Device Single AuditProgram£¨Ò½ÁÆÆ÷еµ¥Ò»ÉóºË³ÌÐò£©£¬Êǹú¼ÊÒ½ÁÆÆ÷е¼à¹ÜÕßÂÛ̳IMDRFµÄMDSAP¼à¹Ü»ú¹¹Î¯Ô±»á·¢ÆðµÄ¡£MDSAPÒ²¾ÍÊÇ¿·¢ÔÚÏß¹ÙÍøios°æÏÂÔØË׳ƵÄÎå¹úÁªÉó£¬ÊÇÃÀ¹ú£¨FDA£©¡¢°Ä´óÀûÑÇ£¨TGA£©¡¢°ÍÎ÷£¨ANVISA£©¡¢¼ÓÄôó£¨HC£©¡¢ÈÕ±¾£¨MHLW£©Îå¹úµÄ¼à¹Ü»ú¹¹ÈϿɲ¢¼ÓÈëµÄÒ»Ì×еÄÉóºË³ÌÐò¡£
£¨2£©ANVISA×¢²áÁ÷³Ì
¶ÔÓÚÏëÔÚ°ÍÎ÷Êг¡ÏúÊÛÒ½ÁÆÆ÷еµÄ·Ç±¾ÍÁÉú²úÉÌ£¬ÐèÒª°´ÕÕANVISAµÄ¹æ¶¨½øÐÐÈÏÖ¤ºÍ×¢²á¡£»ù±¾µÄ²½ÖèºÍÁ÷³Ì°üÀ¨È·¶¨²ú¿·¢ÔÚÏßappÏÂÔرð£¬Ö¸¶¨°ÍÎ÷×¢²á³ÖÓÐÈË£¨BRH£©£¬½øÐÐINMETROÈÏÖ¤£¬BGMPÑ鳧£¬×¼±¸¼¼ÊõÎĵµ£¬Ö§¸¶ÉêÇë·ÑÓ㬲¢×îÖÕ»ñµÃÅú×¼ÏúÊÛ¡£
£¨3£©°ÍÎ÷³ö¿ÚÒ½ÁÆÆ÷еµÄÉÏÊÐÐí¿ÉËùÊÊÓõÄÖ÷Òª·¨¹æ
ÔÚ°ÍÎ÷£¬Ò½ÁÆÆ÷еµÄÉÏÊÐÐí¿ÉÐèÒª×ñÊØÈô¸ÉÖ÷Òª·¨¹æ£¬ÕâЩ·¨¹æ°üÀ¨Ò½ÁÆÆ÷еµÄ×¼Èë·¨¹æRDC 185/2001ºÍRDC 40/2015£¬ÒÔ¼°ÁÙ´²ÊÔÑé·¨¹æRDC 10/2015ºÍÒ½ÁÆÆ÷еÖÆÔìÉ̵ÄGMP·¨¹æRDC 183/2017¡£
°ÍÎ÷µÄÒ½ÁÆÆ÷еÊг¡ËäÈ»¾Þ´ó£¬µ«ÊÇÊг¡×¼ÈëµÄ·¨¹æÒ²Ïà¶Ô¸´ÔÓ¡£¶ÔÓÚÏëÔÚ°ÍÎ÷Êг¡ÏúÊÛ²úÆ·µÄ³ö¿ÚÉÌÀ´Ëµ£¬Àí½âºÍ×ñÊØÕâЩ·¨¹æÊǷdz£ÖØÒªµÄ¡£Õâ²»½ö¿ÉÒÔÈ·±£ËûÃǵIJúÆ·Äܹ»ºÏ¹æÉÏÊУ¬Ò²ÓÐÖúÓÚ¼õÉÙ¿ÉÄܵķ¨ÂÉ·çÏպͲ»±ØÒªµÄ³É±¾¡£
×î³õ·¢²¼ÓÚ2023Äê6ÔÂ29ÈÕ @
? 2024. All Rights Reserved. »¦ICP±¸2023007705ºÅ-2 »¦¹«Íø°²±¸31011502009912ºÅ