Íæ²ÊÍø

½Ó´ýÀ´µ½Íæ²ÊÍø¼¯ÍŹÙÍø£¡

Ò½ÁÆÆ÷еȫÇò×¢²áЧÀÍ/ϵͳÈÏÖ¤/ÁÙ´²ÊÔÑéÊðÀí-Íæ²ÊÍø×Éѯ

רע ¡¤ רÐÄ ¡¤ רҵµÄÒ½ÁÆÆ÷е×Éѯ»ú¹¹

×ܹ«Ë¾

0755-27391220

¹ãÖݹ«Ë¾

020-82513196

ЧÀÍÏîÄ¿

ÄúµÄλÖãºÊ×ҳЧÀÍÏîĿЧÀÍÏîÄ¿

ÆäËûרÌâÅàѵЧÀÍ

¸÷¹úϵͳ¹æÔòºÍ±ê×¼Åàѵ£¬£¬ £¬ £¬£¬£¬µç×ÓÑ̵ÄTPMPÅàѵ£¬£¬ £¬ £¬£¬£¬Î£º¦ÖÎÀíÅàѵ£¬£¬ £¬ £¬£¬£¬Èí¼þÉúÃüÖÜÆÚÅàѵ£¬£¬ £¬ £¬£¬£¬¿ÉÓÃÐÔÅàѵ£¬£¬ £¬ £¬£¬£¬ÁÙ´²GCPÅàѵ£¬£¬ £¬ £¬£¬£¬Àú³ÌÈ·ÈÏÅàѵ£¬£¬ £¬ £¬£¬£¬ÅÌËã»ú»¯Èí¼þÈ·ÈÏÅàѵ£¬£¬ £¬ £¬£¬£¬¸÷¹ú×¢²á¹æÔòÅàѵ£¬£¬ £¬ £¬£¬£¬ÁÙ´²ÆÀ¹ÀÒÔ¼°Ò½ÁÆÆ÷еÆóÒµ×Ô½ç˵µÄרÌâÅàѵ£¬£¬ £¬ £¬£¬£¬ÍøÂçÇå¾²Åàѵ£¬£¬ £¬ £¬£¬£¬ºã¾Ã¹æÔòÕÕÁÏЧÀ͵È
Éó²éÏêÇé Á¬Ã¦×Éѯ

Ó¢¹úÊÚȨ´ú±íЧÀÍ

ΪҽÁÆÆ÷еÆóÒµÔÚÓ¢¹úÍÆÐÐÊÚȨ´ú±íÖ°Ô𡣡£ ¡£¡£¡£¡£
Éó²éÏêÇé Á¬Ã¦×Éѯ

ÆäËû¹ú¼ÒÒ½ÁÆÆ÷еע²áÊðÀíЧÀÍ

°£¼°Ò½ÁÆÆ÷еע²áÊðÀíЧÀÍ£¬£¬ £¬ £¬£¬£¬°¢ÂüÒ½ÁÆÆ÷еע²áÊðÀíЧÀÍ£¬£¬ £¬ £¬£¬£¬¸çÂ×±ÈÑÇÒ½ÁÆÆ÷еע²áÊðÀíЧÀÍ£¬£¬ £¬ £¬£¬£¬°¢¸ùÍ¢Ò½ÁÆÆ÷еע²áÊðÀíЧÀÍ£¬£¬ £¬ £¬£¬£¬Ó¡¶ÈÒ½ÁÆÆ÷еע²áÊðÀíЧÀÍ£¬£¬ £¬ £¬£¬£¬Ä«Î÷¸çÒ½ÁÆÆ÷еע²áÊðÀíЧÀÍ£¬£¬ £¬ £¬£¬£¬ÐÂ¼ÓÆÂÒ½ÁÆÆ÷еע²áÊðÀíЧÀÍ£¬£¬ £¬ £¬£¬£¬ÂíÀ´Î÷ÑÇÒ½ÁÆÆ÷еע²áÊðÀíЧÀÍ£¬£¬ £¬ £¬£¬£¬Ì©¹úÒ½ÁÆÆ÷еע²áÊðÀíЧÀÍ£¬£¬ £¬ £¬£¬£¬Ô½ÄÏÒ½ÁÆÆ÷еע²áÊðÀíЧÀÍ£¬£¬ £¬ £¬£¬£¬ÎÚ¿ËÀ¼Ò½ÁÆÆ÷еע²áÊðÀíЧÀÍ£¬£¬ £¬ £¬£¬£¬¶íÂÞ˹ҽÁÆÆ÷еע²áÊðÀíЧÀÍ£¬£¬ £¬ £¬£¬£¬º«¹úÒ½ÁÆÆ÷еע²áÊðÀíЧÀÍ¡£¡£ ¡£¡£¡£¡£
Éó²éÏêÇé Á¬Ã¦×Éѯ

°¢À­²®ÁªºÏÇõ³¤¹ú×¢²áÊðÀíЧÀÍ

°¢À­²®ÁªºÏÇõ³¤¹ú£¬£¬ £¬ £¬£¬£¬¼ò³Æ°¢ÁªÇõ£¬£¬ £¬ £¬£¬£¬Ê×¶¼ÔÚ°¢²¼Ôú±È£¬£¬ £¬ £¬£¬£¬ÊÇÓëÉ³ÌØ°¢À­²®½»½ÓµÄ°¢À­²®¹ú¼Ò¡£¡£ ¡£¡£¡£¡£ÔÚ°¢ÁªÇõ£¬£¬ £¬ £¬£¬£¬Ò½ÁÆÆ÷еºÍÌåÍâÕï¶ÏÒ½ÁÆÆ÷е¶¼ÊÇÊܵ½°¢ÁªÇõÎÀÉú¾Ö£¨Ministry of Health and Prevention, ¼ò³ÆMOHAP£©ÏµÄÒ©Æ·¹Ü¿Ø²¿·ÖDrug Control Department¾ÙÐÐî¿Ïµ¡£¡£ ¡£¡£¡£¡£
ÖµµÃ×¢ÖØµÄÊÇ£º¾³ÍâÆóÒµÔÚ°¢ÁªÇõÐèÒªÕÒµ½ÍâµØÕýµ±µÄÊðÀí£¨Agent£©À´¾ÙÐÐÒ½ÁÆÆ÷е·ÖÀàµÝ½»£¬£¬ £¬ £¬£¬£¬×¢²áµÝ½»ÒÔ¼°ÓëMOHAP¾ÙÐÐÏàͬ¡£¡£ ¡£¡£¡£¡£Í¬Ê±£¬£¬ £¬ £¬£¬£¬ÍâµØ´ú±íÔÚ°¢ÁªÇõÉÐÓÐÒ»¸öºÜÊÇÖ÷ÒªµÄ½ÇɫҲÊDz»¿ÉÌæ»»µÄ£¬£¬ £¬ £¬£¬£¬¾ÍÊÇÈë¿ÚÔÊÐíµÄÉêÇëÈË£¬£¬ £¬ £¬£¬£¬Ö»ÓÐͨ¹ýÍâµØ´ú±í²Å»ª¾ÙÐвúÆ·»ñÖ¤ºóÈë¿ÚÔÊÐíµÄÉêÇëºÍ¿ª¾ß£¬£¬ £¬ £¬£¬£¬ÄÇôҲ¾ÍÒâζ×ÅÄúµÄÍâµØ´ú±íÕÕ¾ÉÐèҪЭÖúÄúÍê³ÉºóÐøµÄÈë¿Ú»·½ÚµÄÊÂÒË¡£¡£ ¡£¡£¡£¡£
Éó²éÏêÇé Á¬Ã¦×Éѯ

É³ÌØSFDA×¢²áÊðÀíЧÀÍ

É³ÌØÊ³ÎïºÍÒ©Æ·ÖÎÀí¾Ö(SFDA, The Saudi Food and Drug Authority)¡£¡£ ¡£¡£¡£¡£ÈÏÕæî¿Ïµ¡¢¼àÊӺͼà²âʳÎï¡¢Ò©Æ·¡¢Ò½ÁÆÆ÷е£¬£¬ £¬ £¬£¬£¬²¢Öƶ©Ç¿ÖÆÐÔ±ê×¼¹æ·¶£¬£¬ £¬ £¬£¬£¬ÈÏÕæ SFDA »òÆäËû»ú¹¹ÊµÑéÊҵļà²âºÍ/»ò²âÊÔÔ˶¯µÄ»ú¹¹¡£¡£ ¡£¡£¡£¡£±ðµÄ£¬£¬ £¬ £¬£¬£¬SFDA»¹ÈÏÕæÏûºÄÕß¶ÔÓëʳÎï¡¢Ò©Æ·ºÍÒ½ÁÆÆ÷еÒÔ¼°ËùÓÐÆäËû²úÆ·ºÍÓÃÆ·ÓйصÄËùÓÐÊÂÏîµÄÈÏÖ¤¡£¡£ ¡£¡£¡£¡£
É³ÌØÒ½ÁÆÆ÷е²¿·Ö£¨Medical Devices Sector£©ÔÚÖÜÈ«µÄÁ¢·¨ºÍî¿ÏµÏÂÈ·±£Ò½ÁÆÆ÷еµÄÇå¾²ÐÔ¡¢ÓÐÓÃÐÔºÍÐÔÄÜ·½ÃæÊ©Õ¹×ÅÒªº¦×÷Óᣡ£ ¡£¡£¡£¡£É³ÌØÒ½ÁÆÆ÷еî¿Ïµ¿ò¼ÜÔÚЭЭµ÷Ç÷ͬ·½ÃæÓë¹ú¼ÊÀÏÀý¼á³ÖÒ»Ö£¬£¬ £¬ £¬£¬£¬ËüÊÇÈ«ÇòЭµ÷ÊÂÇé×é (GHWP) µÄÖ÷ϯ£¬£¬ £¬ £¬£¬£¬Ò²ÊÇ IMDRF ºÍ ISO ¶à¸öÊÖÒÕίԱ»áµÄÆð¾¢³ÉÔ±¡£¡£ ¡£¡£¡£¡£
2019 Äê 12 Ô£¬£¬ £¬ £¬£¬£¬É³Ìذ¢À­²®ÍƳöÁËеÄͳһµç×Óϵͳ¡°GHAD¡±£¬£¬ £¬ £¬£¬£¬È¡´úÁËÏÖÓеÄÒ½ÁÆÆ÷еÉÏÊС¢×¢²áºÍÉèÁ¢ÔÊÐíϵͳ£¨MDMA¡¢MDNR ºÍ SFDA£©¡£¡£ ¡£¡£¡£¡£×Ô 2021 Äê 7 ÔÂÆð£¬£¬ £¬ £¬£¬£¬ÍâµØºÍÍâ¹úÒ½ÁÆÆ÷ÐµÖÆÔìÉÌÐèÒªÔÚÐÂϵͳ GHAD ÏÂ×¢²á»ò¸üÐÂÆäÔÊÐíÖ¤¡£¡£ ¡£¡£¡£¡£
ÖµµÃ×¢ÖØµÄÊÇ£ºÔÚÉ³ÌØ¾ÙÐÐSFDA×¢²áǰÐèÒªÔÚÍâµØÈ·¶¨Ò»¸öÕýµ±µÄÊÚȨ´ú±í£¨AR£©£¬£¬ £¬ £¬£¬£¬ÒÔ±ãÓëSFDA¾ÙÐÐ×¢²áÈÏÖ¤Ïàͬ¡£¡£ ¡£¡£¡£¡£
Éó²éÏêÇé Á¬Ã¦×Éѯ

ÐÂÎ÷À¼Medsafe×¢²áÊðÀíЧÀÍ

ÐÂÎ÷À¼Medsafe£¨Medicines and Medical Devices Safety Authority£¬£¬ £¬ £¬£¬£¬ÓÖ³ÆÒ©Æ·ºÍÒ½ÁÆÆ÷еÇå¾²ÖÎÀí¾Ö£©ÊÇÐÂÎ÷À¼Õþ¸®ÈÏÕæî¿ÏµºÍÖÎÀíÒ©Æ·¡¢Ò½ÁÆÆ÷еºÍÆäËûÒ½ÁƲúÆ·µÄ»ú¹¹¡£¡£ ¡£¡£¡£¡£MedsafeÈÏÕæÆÀ¹ÀºÍÉóÅúÒ½ÁƲúÆ·µÄ×¢²á¡¢î¿ÏµÒ½ÁƲúÆ·µÄÖÊÁ¿¡¢Çå¾²ÐÔºÍÓÐÓÃÐÔ¡¢¼àÊÓÉú²úºÍÏúÊ۵ȡ£¡£ ¡£¡£¡£¡£MedsafeµÄÖ÷ҪʹÃüÊÇÈ·±£ÐÂÎ÷À¼Êг¡ÉϵÄÒ½ÁƲúÆ·ÇкϹú¼ÒºÍ¹ú¼ÊµÄ±ê×¼ºÍÒªÇ󣬣¬ £¬ £¬£¬£¬°ü¹Ü¹«ÖڵĿµ½¡ºÍÇå¾²¡£¡£ ¡£¡£¡£¡£Îª´Ë£¬£¬ £¬ £¬£¬£¬MedsafeÓëÆäËû¹ú¼ÊÒ½Ò©î¿Ïµ»ú¹¹¼á³ÖϸÃÜÏàÖú£¬£¬ £¬ £¬£¬£¬ÅäºÏÔö½øÒ½ÁƲúÆ·µÄÇå¾²ºÍ¿É¿¿ÐÔ¡£¡£ ¡£¡£¡£¡£
ÈçÒ½ÁÆÆ÷еÆóÒµ»ñµÃÁËÅ·ÃËCEÈÏÖ¤¡¢ÃÀ¹úFDA¡¢»ò¼ÓÄôóÎÀÉú²¿µÄMDL/MDEL×¢²áÈÏÖ¤£¬£¬ £¬ £¬£¬£¬ÔòÔÚÐÂÎ÷À¼ÉÏÊкó30ÌìÄÚ£¨´Ó×°±¸Ê״εִïÐÂÎ÷À¼ÈÕÆÚ×îÏÈ£©ÐèÒªÍâµØÖ¸¶¨ÔÞÖúÉÌ£¨Sponsor£©½«ÄúµÄ²úÆ·ÁÐÈë MedSafe µÄWAND(Web Assisted Notification of Devices)Êý¾Ý¿â¡£¡£ ¡£¡£¡£¡£
ÖµµÃ×¢ÖØµÄÊÇ£ºÐÂÎ÷À¼Ò²ÊÇÓÉÍâµØÖ¸¶¨ÔÞÖúÉÌ£¨Sponsor£©³ÖÖ¤£¬£¬ £¬ £¬£¬£¬È«È¨ÈÏÕæ¾³ÍâÆóÒµÔÚÐÂÎ÷À¼ÍâµØµÄÆ÷еע²áÉÏÊУ¬£¬ £¬ £¬£¬£¬¼ç¸ºÖ´·¨ÔðÈΣ»£»£»¶Ô WAND ÖÐÐÅÏ¢µÄ׼ȷÐÔÈÏÕæ£¬£¬ £¬ £¬£¬£¬²¢ÇÒÊÇ Medsafe µÄΨһÁªÂçÈË¡£¡£ ¡£¡£¡£¡£
Éó²éÏêÇé Á¬Ã¦×Éѯ

ÈÕ±¾PMDA×¢²áÊðÀíЧÀÍ

Ò½ÁÆÆ÷еÆóҵϣÍû°Ñ²úƷͶ·Åµ½ÈÕ±¾Êг¡£¬£¬ £¬ £¬£¬£¬±ØÐèÒªÖª×ãÈÕ±¾µÄ Pharmaceutical and Medical Device Act (PMD Act)¹æÔò¡£¡£ ¡£¡£¡£¡£
ÈÕ±¾ºñÉúÀͶ¯Ê¡£¡£ ¡£¡£¡£¡£¨MHLW£¬£¬ £¬ £¬£¬£¬È«³ÆÎª¡°Ministry of Health, Labour and Welfare¡±£©ÏÂÊô²¿·Ö£ºÒ©Æ·ºÍÒ½ÁÆÆ÷е¾Ö (PMDA,È«³ÆÎª¡°Pharmaceuticals and Medical Devices Agency¡±)ÊÇÈÕ±¾µÄî¿Ïµ»ú¹¹¡£¡£ ¡£¡£¡£¡£
Ò½ ÁÆ Æ÷ е ±Ø Ðë Òª ÓÉ Æä ÊÐ ³¡ Õýµ±ÊÚ È¨ ´ú±í MAH £¨ Marketing Authorization Holder £©Í¨¹ýÒÔϳÌÐòÈ¥×¢²áÆä²úÆ·¡£¡£ ¡£¡£¡£¡£
Class I Æ÷е - ÉÏÊÐÌõ¼þ½» Todokede
IÀàÆ÷еÉÏÊÐǰ±ØÐèÓÉÆä MAH»ò DMAHÏò PMDA Ìá½»Ò»·ÝÉÏÊÐÌõ¼þ½»Îļþ£¬£¬ £¬ £¬£¬£¬Õâ·ÝÎļþ²»ÐèÒª¾­ÓÉ PMDAµÄÉóºËºÍÅú×¼¡£¡£ ¡£¡£¡£¡£
Class II Æ÷е - ÉÏÊÐǰÈÏÖ¤ Ninsho
×÷ÎªÌØÊâ¿ØÖÆµÄ II ÀàÆ÷еÉÏÊÐǰ±ØÐèÒª¾­ÓÉÉÏÊÐǰÈÏÖ¤¡£¡£ ¡£¡£¡£¡£ÈÏÖ¤»ú¹¹£¨PCB£©Îª PMDA ÊÚȨ¿ÉÒÔ¾ÙÐÐ PMDAÈÏÖ¤µÄ»ú¹¹¡£¡£ ¡£¡£¡£¡£
Class II£¬£¬ £¬ £¬£¬£¬III,IV Æ÷е - ÉÏÊÐǰÅú×¼ Shonin
³ýÁËÌØÊâ¿ØÖÆµÄ II ÀàÆ÷еÍâµÄÆäËû II ÀàÆ÷еºÍ III,IV ÀàÆ÷е±ØÐèÒªÓÉÆä MAH »ò DMAH ÏñPMDAÌá½»ÉÏÊÐǰÅú×¼µÄÉêÇ룬£¬ £¬ £¬£¬£¬²¢¾­ÓÉ PMDAÅú×¼ºó²Å»ª×¢²áËûÃǵIJúÆ·£¬£¬ £¬ £¬£¬£¬²¢Í¶·ÅÊг¡¡£¡£ ¡£¡£¡£¡£
ÖµµÃ×¢ÖØµÄÊÇ£º¾³ÍâµÄÒ½ÁÆÆ÷е½øÈëÈÕ±¾×¢²áʱֻÄÜÓÉÈÕ±¾ÊÚȨ´ú±í£¨MAH»òDMAH£©³ÖÖ¤£¬£¬ £¬ £¬£¬£¬¾³ÍâµÄÒ½ÁÆÆ÷ÐµÖÆÔìÉÌÖ»»ñµÃ¡°Ò½ÁÆÆ÷еÍâ¹úÖÆÔìÒµÕßÉϰ¶Ö¤¡±£¨¼´ÏµÍ³Éó²é¼°¸ñÖ¤Ê飩¡£¡£ ¡£¡£¡£¡£
Éó²éÏêÇé Á¬Ã¦×Éѯ

°ÍÎ÷ANVISA×¢²áÊðÀíЧÀÍ

°ÍÎ÷¹ú¼ÒÎÀÉúî¿Ïµ¾Ö£¨ANVISA£©ÈÏÕæî¿Ïµ°ÍÎ÷¾³ÄÚµÄÒ½ÁÆÆ÷еÔ˶¯¡£¡£ ¡£¡£¡£¡£ÔÚ²úÆ·×¢²áÁ÷³Ì×îÏÈǰ£¬£¬ £¬ £¬£¬£¬Ê×ÏÈÐèÒª¶Ô²úÆ·¾ÙÐзÖÀ࣬£¬ £¬ £¬£¬£¬ANVISA½«²úÆ··ÖΪËÄÀ༴IÀà¡¢IIÀà¡¢IIIÀàºÍIVÀ࣬£¬ £¬ £¬£¬£¬Î£º¦ÖÖ±ðÒ²ËæÖ®ÉÏÉý¡£¡£ ¡£¡£¡£¡£ÎªÁ˼ò»¯µÍΣº¦ÖÖ±ðΣº¦Æ÷еµÄ×¢²áÁ÷³Ì£¬£¬ £¬ £¬£¬£¬2022Äê9ÔÂANVISA¼ò»¯ÁËIÀàºÍIIÀàÒ½ÁÆÆ÷е²úÆ·µÄ×¢²áÁ÷³Ì£¬£¬ £¬ £¬£¬£¬Ö®Ç°µÄ×¢²á·¾¶Cadastro±ä»»ÎªNotification¡£¡£ ¡£¡£¡£¡£°ÍÎ÷µÄ²úÆ·×¢²á·ÖΪÁ½ÖÖ·¾¶NotificationºÍRegistro¡£¡£ ¡£¡£¡£¡£Î£º¦¼¶±ð½ÏµÍµÄ²úÆ·£¨IÀà²úÆ·ºÍIIÀà²úÆ·£©µÄ×¢²á·¾¶ÎªNotification·¾¶£¬£¬ £¬ £¬£¬£¬Î£º¦½Ï¸ßµÄ²úÆ·£¨IIIÀàºÍIVÀà²úÆ·£©¿ÉÒÔͨ¹ýRegistro·¾¶¾ÙÐÐ×¢²á¡£¡£ ¡£¡£¡£¡£
ÏÖÐÐÒ½ÁÆÆ÷еî¿Ïµ¹æÔò£ºRDC 751-2022£¨2023Äê3ÔÂ1ÈÕÉúЧ£¬£¬ £¬ £¬£¬£¬·ÏÖ¹ÁËÔ­¹æÔòRDC 185/2001£©
±ØÐèÇ¿µ÷µÄÊÇ£ºa.°ÍÎ÷Ö®ÍâµÄÍâÑóÆóÒµÈÏ֤ʱÐèÒªµ½°ÍÎ÷ÕÒÕýµ±µÄÊÚȨ´ú±í£¨°Í´úBRH£©,²¢ÇÒÖ»ÄÜÓɸÃÊÚȨ´ú±í³ÖÖ¤£»£»£»b.²úÆ·ÇкÏÒ½ÁÆÆ÷е¹æÔòÇÒ´øµçµÄ²úÆ·ÐèÒªÔÚÉêÇëǰ×öINMETROÈÏÖ¤£¬£¬ £¬ £¬£¬£¬´øÀ¶ÑÀµÄÐèÒª×öANATELÈÏÖ¤£»£»£»c.²úÆ·µÄ×¢²áÉêÇë±í¡¢ËµÃ÷Êé¡¢±êÇ©±ØÐèÒÔÆÏÌÑÑÀÓïÌṩ£¬£¬ £¬ £¬£¬£¬ÆäËûÊÖÒÕÎļþ¿ÉÒÔÊÇÆÏÌÑÑÀÓï¡¢Î÷°àÑÀÓï»òÕßÓ¢Óï¡£¡£ ¡£¡£¡£¡£
Éó²éÏêÇé Á¬Ã¦×Éѯ
×Éѯ

µç»°

×ܹ«Ë¾

0755-27391220

¹ãÖÝÈÈÏß

020-82513196

΢ÐÅ

¶þάÂë

΢Ðſͷþ

¶þάÂë

С³ÌÐò

ÓÊÏä

ÆóÒµÓÊÏä

www.reanny@reanny.com

¡¾ÍøÕ¾µØÍ¼¡¿