The Quality Of The National Medical Equipment

The quality of the national medical equipment


In order to strengthen the quality supervision and management of medical equipment and ensure 

the

 safe and effective use of medical equipment products, the State Food and Drug Administration has 

carried out quality supervision and inspection of 79 batches of six varieties of surgical clothing,

 high frequency operation equipment and total thyroxine detection reagent. The Now the sampling

 results are as follows:


The sampling items do not meet the standard medical equipment products, involving two medical

 equipment manufacturing enterprises of the two varieties of two (Taiwan).

(A) surgical clothing 1 business 1 batch of products. Jilin Fulang Medical Technology Co., Ltd. 

produced a batch of one-time use of surgical clothing, impermeability (product non-critical areas)

 does not meet the standard requirements.

(2) high-frequency surgical equipment 1 enterprise 1 product. Guangdong Baisheng Medical Devices 

Co., Ltd. produced a high-frequency electric knife, the enclosure of the closed does not meet the

 standard requirements.


The above sampling does not meet the specific requirements of the product, see Annex 1.


Was sampling items for the identification of labels, brochures and other items do not meet the 

standards of medical equipment products, involving two medical equipment manufacturing enterprises

 of the two varieties of two.

(A) infusion pump / syringe pump 1 enterprise 1 product. An external marking of an infusion pump,

 equipment or equipment part produced by Changsha Yiyang Medical Instrument Co., Ltd. does not

 meet the standard requirements.

(2) high-frequency surgical equipment 1 enterprise 1 product. Guangdong Baisheng Medical Devices

 Co., Ltd. produced a high-frequency electric knife, equipment or equipment parts of the external

 mark does not meet the standard requirements.


The above sampling does not meet the specific requirements of the product, see Annex 2.


Third, the sampling project all meet the standard medical device products related to 43 medical

 equipment manufacturing enterprises of the three varieties of 76 batches, see Annex 3.

Fourth, the sampling found in the non-compliance with the provisions of the product, the State

 Food and Drug Administration has requested the location of food and drug supervision and 

management departments in accordance with the "Medical Device Supervision and Management

 Regulations" and "Food and Drug Administration General Office on further strengthening the 

medical equipment Sampling work notice "(Food and Drug Administration Supervision 〔2016〕 9),

 the relevant enterprises to investigate and deal with.

Related medical equipment manufacturing enterprises should not meet the standard requirements 

of the product, do not meet the standards of the project risk assessment, according to the

 severity of medical equipment to determine the level of recall, take the initiative to recall

 and public recall information. The provincial food and drug supervision and administration 

departments at the provincial level shall supervise the recall situation of the enterprise and 

shall be recalled if they do not organize the recall. If the medical device products are found

 to be harmless to the human body or if there is evidence to prove that they may endanger human 

health, Suspension of production, import, operation, use of emergency control measures. Relevant 

provincial food and drug supervision and management departments to urge enterprises to identify

 the cause as soon as possible, to develop corrective measures and rectification in place, the 

disposal of the situation in April 24, 2017 to the public before the announcement.