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National Medical Device Quality Announcement (No. 4, 2017, No. 22 in total)
In order to strengthen the quality supervision and management of medical devices and ensure the safe and effective use of medical device products, the State Food and Drug Administration organized 122 batches of products of two varieties of metal spinal screws and metal spinal rods for quality supervision and random inspection. The results of the random inspection are now announced as follows:
1. Medical device products whose items are randomly inspected do not meet the requirements of the standard, involving one product and one batch of one medical device manufacturer. Specifically:
Metal spinal rods are produced by 1 company and 1 batch. Pioneer Surgical Technology, Inc. produced a batch (spine fixation system-orthopedic rod, hexagonal end), the size does not meet the standard requirements.
Please refer to Annex 1 for the specific conditions of products that do not meet the standard requirements in the above random inspections.
2. All the medical device products in the random inspection items that meet the requirements of the standard involve 121 batches of 2 varieties from 60 medical device manufacturers, see Annex 2.
3. For the products found in the above-mentioned random inspections that do not meet the standard requirements, the State Food and Drug Administration has required the food and drug regulatory authorities where the company is located to follow the Regulations on the Supervision and Administration of Medical Devices and the General Office of the Food and Drug Administration on further strengthening medical devices "Notice on Sampling Inspection" (Food and Drug Administration, Ban Xia Jian [2016] No. 9), to investigate and deal with relevant enterprises.
Relevant medical device manufacturers should conduct risk assessments for products that do not meet the standards and items that do not meet the standards, determine the recall level according to the severity of the medical device defects, and actively recall and disclose the recall information. The provincial food and drug supervision and administration department where the company is located shall supervise the recall of the company. If the recall is not organized, the recall shall be ordered; if it is found that the medical device product that does not meet the standards and regulations has caused harm to the human body or there is evidence that it may endanger human health, it shall take Suspend emergency control measures for production, import, operation, and use. The relevant provincial food and drug supervision and administration departments should urge enterprises to find out the reasons as soon as possible, formulate corrective measures, and make corrective actions in place on schedule. The relevant disposal situation will be announced to the public before April 14, 2017.
1. Medical device products whose items are randomly inspected do not meet the requirements of the standard, involving one product and one batch of one medical device manufacturer. Specifically:
Metal spinal rods are produced by 1 company and 1 batch. Pioneer Surgical Technology, Inc. produced a batch (spine fixation system-orthopedic rod, hexagonal end), the size does not meet the standard requirements.
Please refer to Annex 1 for the specific conditions of products that do not meet the standard requirements in the above random inspections.
2. All the medical device products in the random inspection items that meet the requirements of the standard involve 121 batches of 2 varieties from 60 medical device manufacturers, see Annex 2.
3. For the products found in the above-mentioned random inspections that do not meet the standard requirements, the State Food and Drug Administration has required the food and drug regulatory authorities where the company is located to follow the Regulations on the Supervision and Administration of Medical Devices and the General Office of the Food and Drug Administration on further strengthening medical devices "Notice on Sampling Inspection" (Food and Drug Administration, Ban Xia Jian [2016] No. 9), to investigate and deal with relevant enterprises.
Relevant medical device manufacturers should conduct risk assessments for products that do not meet the standards and items that do not meet the standards, determine the recall level according to the severity of the medical device defects, and actively recall and disclose the recall information. The provincial food and drug supervision and administration department where the company is located shall supervise the recall of the company. If the recall is not organized, the recall shall be ordered; if it is found that the medical device product that does not meet the standards and regulations has caused harm to the human body or there is evidence that it may endanger human health, it shall take Suspend emergency control measures for production, import, operation, and use. The relevant provincial food and drug supervision and administration departments should urge enterprises to find out the reasons as soon as possible, formulate corrective measures, and make corrective actions in place on schedule. The relevant disposal situation will be announced to the public before April 14, 2017.
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