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- £¨Ò»£©ÊéÃæÉêÇëÊ飬²¢ÓÐÊÚȨÈËÇ©×ֺ͵¥Î»¸ÇÕ£» (1) An application in written form with a signature of the authorized person and the official seal thereon;
- £¨Ò»£©Î´±êÃ÷ÓÐЧÆÚ»òÕ߸ü¸ÄÓÐЧÆڵģ» (1) An expiry date is not indicated or is altered; or
- £¨Ò»£©Ö²ÈëÈËÌåµÄÒ½ÁÆÆ÷е£» (1) Any medical instrument implanted into the human body;
- £¨Ò»£©½éÈëÈËÌåµÄÎÞÔ´Ò½ÁÆÆ÷е£» (1) Any unpowered medical instrument intervening in the human body;
- £¨Ò»£©¾ßÓиߵÈѧУҽѧרҵ±¾¿ÆÒÔÉÏѧÀú£¬ÔÚִҵҽʦָµ¼Ï£¬ÔÚÒ½ÁÆ¡¢Ô¤·À¡¢±£½¡»ú¹¹ÖÐÊÔÓÃÆÚÂúÒ»ÄêµÄ£» (1) Anyone who has received at least regular medical college education in an institution of higher learning, and has, under the supervision of a medical practitioner, served at least one year on probation in an institution of medical treatment, prevention or health care; or
- £¨Ò»£©·ûºÏ±¾ÌõÀýµÚÁùÌõ¹æ¶¨µÄÆ·ÖÖ»òÕßÒѾ½â³ýÒ»¼¶±£»¤µÄÆ·ÖÖ£»? (1) are conforming with the stipulations set forth in Article 6, and are removed from Grade 1 protection;
- £¨Ò»£©¶ÔÌض¨¼²²¡ÓÐÌØÊâÁÆЧµÄ£»? (1) are with special therapeutic results to a given disease;
- £¨Ò»£©Ò»Àà½ø¿Úµ¥Î»½ø¿ÚµÄ£¬ÄêÅú´ÎÏÖ³¡¼ìÑéÂʲ»µÍÓÚ10%£» (1) As for the import by a Category A importer, the annual rate of spot inspection of batches shall not be lower than 10 percent;
- £¨Ò»£©Ò»Àà½ø¿Úµ¥Î»½ø¿ÚµÄ£¬ÄêÅú´ÎÏÖ³¡¼ìÑéÂʲ»µÍÓÚ30%£» (1) As for the import by a Category A importer, the annual rate of spot inspection of batches shall not be lower than 30 percent;
- £¨Ò»£©Ò»Àà½ø¿Úµ¥Î»½ø¿ÚµÄ£¬ÊµÊ©ÏÖ³¡¼ìÑéÓë¼à¶½¼ìÑéÏà½áºÏµÄ·½Ê½£¬ÆäÖÐÄêÅú´ÎÏÖ³¡¼ìÑéÂʲ»µÍÓÚ50%£» (1) As for the import by a Category A importer, the spot inspection shall be performed combining with surveillant inspection, and the annual rate of spot inspection of batches shall not be lower than 50 percent; and
- £¨¶þ£©ÒÔ·ÇҩƷð³äÒ©Æ·»òÒÔËûÖÖҩƷð³ä´ËÖÖÒ©Æ·µÄ¡£ (2) A non-medical substance is passed off as a medicine, or one medicine is passed off as another.
- £¨¶þ£©²»×¢Ã÷»òÕ߸ü¸ÄÉú²úÅúºÅµÄ£» (2) A registration number is not indicated or is altered; or
- £¨¶þ£©ÒÔ·ÇҩƷð³äÒ©Æ·»òÕßÒÔËûÖÖҩƷð³ä´ËÖÖÒ©Æ· (2) A substance that is not a drug is passed off as a drug, or one sort of drug is passed off as another drug.
- £¨¶þ£©µ÷ÕûȱÏݽø¿ÚÒ½ÁÆÆ÷е½ø¿Úµ¥Î»µÄ·ÖÀà¹ÜÀíµÄÀà±ð£» (2) adjusting the category of the importer of the defective medical instruments in the classified management;
- £¨¶þ£©´æÔÚ°²È«ÎÀÉúȱÏÝ»òÕß¿ÉÄÜÔì³É½¡¿µÒþ»¼¡¢»·¾³ÎÛȾµÄ£» (2) any defectiveness in safety and sanitation or any possible potential health risks or environmental pollution; or
- £¨¶þ£©²»ÊôÓڸ߷çÏÕµÄÆäËûÓëÈËÌå½Ó´¥µÄÓÐÔ´Ò½ÁÆÆ÷е£» (2) Any other powered medical instrument contacting the human body but not at the level of high risk; and
- £¨¶þ£©½éÈëÈËÌåµÄÓÐÔ´Ò½ÁÆÆ÷е£» (2) Any powered medical instrument intervening in the human body;
- £¨¶þ£©Ï൱ÓÚ¹ú¼ÒÒ»¼¶±£»¤Ò°ÉúÒ©²ÄÎïÖÖµÄÈ˹¤ÖƳÉÆ·£»? (2) are prepared with natural medicinal herbs covered by Grade 1 protection by the state; and
- £¨¶þ£©¶ÔÌض¨¼²²¡ÓÐÏÔÖøÁÆЧµÄ£»? (2) are with noticeable therapeutic results to a given disease; and
- £¨¶þ£©¶þÀà½ø¿Úµ¥Î»½ø¿ÚµÄ£¬ÄêÅú´ÎÏÖ³¡¼ìÑéÂʲ»µÍÓÚ30%£» (2) As for the import by a Category B importer, the annual rate of spot inspection of batches shall not be lower than 30 percent; and
- £¨¶þ£©¶þÀà½ø¿Úµ¥Î»½ø¿ÚµÄ£¬ÄêÅú´ÎÏÖ³¡¼ìÑéÂʲ»µÍÓÚ50%£» (2) As for the import by a Category B importer, the annual rate of spot inspection of batches shall not be lower than 50 percent; and
- £¨¶þ£©¶þ¡¢ÈýÀà½ø¿Úµ¥Î»½ø¿ÚµÄ£¬ÊµÊ©ÅúÅúÏÖ³¡¼ìÑé¡£ (2) As for the import by a Category B or C importer, the spot inspection of each batch shall be performed.
- £¨Èý£©ÓÃÓÚÖ§³Ö¡¢Î¬³ÖÉúÃüµÄÒ½ÁÆÆ÷е£» (3) Any medial instrument used for the life support or life maintenance;
- £¨Èý£©²úÆ·ÖÊÁ¿½Ï²»Îȶ¨£¬¶à´Î·¢ÉúÖÊÁ¿ÎÊÌ⣬¶ÔÆ䰲ȫÐÔÓÐЧÐÔ±ØÐëÑϸñ¿ØÖƵÄÒ½ÁÆÆ÷е¡£ (3) Any medical instrument that are unstable in product quality, have led to quality problems for several times, and must be controlled rigidly in product safety and effectiveness.
- £¨Èý£©¿ÉÄÜΣº¦Ò½»¼ÕßÉúÃü²Æ²ú°²È«£¬Çé¿ö½ô¼±µÄ¡£ (3) any possible circumstance that may harm the life or property safety of the doctor or patient or any emergency.
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