Medical network - on February 9, on February 8, state administration of drug safety published "measures for the management of medical device recall" (hereinafter referred to as the "method"), will be effective as of May 1, 2017.
On June 1, 2014, the newly revised regulations on the supervision and administration of medical devices issued and implemented, and puts forward new requirements for medical device recall. On this basis, the drug safety administration of the original "medical device recall management approach (trial)" (hereinafter referred to as the "method (try out)") were modified, and form a "method", and on January 5, 2017, drug safety administration of China, adopted at the meeting examined and approved.
Revision of the "method", "method (try out)" retained the framework and main content, but also focus on the scope of the recall and complementary and adjusted the individual operating procedures, enhanced production enterprise's main body responsibility and legal responsibility, increasing the penalties for violation behavior.
Major changes include:
1, implement the main responsibility of medical device recall
Registrant or clear in medical devices for the record, import overseas manufacturers of medical equipment in China designated agent is the main part of the implementation of medical device recall.
2, has been clear about the scope of application
"Method (try out)" regulation, "this method is suitable for sale in the territory of the People's Republic of China medical device recall supervision and management".
"Method" is amended as "the territory of the People's Republic of China are on the market of medical device recall and its supervision and management", made clear all registered medical device products in our country, recalled in domestic or overseas, should be implemented according to the requirements of this "method" or report.
3, adjust the scope of the defective product
"Method (try out)" regulation "medical device recall, as mentioned in the present measures refers to the medical device manufacturing enterprise according to the procedures prescribed by the listed defects in a particular category, type of sales or batches of product, take warning, inspection, repair, back label, modify and perfect the specification, software upgrades, replaced, and ways to eliminate defects such as back, destroy behavior", "" defect" as mentioned in the present measures, refers to the medical equipment in normal use may endanger human health and life safety of unreasonable risk ", namely the recall is exist in normal use may endanger human health and life safety risk of unreasonable medical apparatus and instruments.
The methods according to the new revision of the regulations, to expand the scope of the defective product for "(a) under normal use may endanger human health and life safety of unreasonable risk products; (2) do not conform to the compulsory standards, the product technical requirements for registration or registration of products; (3) is not in conformity with the quality management for medical equipment production, circulation unreasonable regulations lead to possible risk products; (4) other products need to be recalled".
4, increased the defect assessment content
Corresponding modifications, to enlarge the range of defective product to evaluate the defects of medical devices in the main content, increase the "whether products conform to the compulsory standards, the product technical requirements for registration or registration".
5, adjust the regulatory supervision of recalled products destroyed
"Method (try out)" regulation "need to be destroyed, shall be destroyed under the supervision of destruction to pharmaceutical supervisory and administrative department". But in practice, this way is not conducive to the actual operation. At the same time, in the current information technology, the diversification of supervision mode is the trend of The Times.
Therefore, "method" changed to "need to destroy, shall be destroyed under the supervision of food and drug supervision and administration department."
6, adjusted the recall of information reporting requirements
"Method (try out)" regulation "the pharmaceutical supervisory and administrative department shall, within 10 days from the date of receiving the summary report to review report, and evaluate the effect of recall. Review and evaluation conclusion medical device manufacturing enterprise shall be notified in written form and sent to the administrative department of public health at the same level". In practice, review and evaluation conclusion written notice to the medical device manufacturing enterprise and notify the health administrative department at the same level requirement is difficult to operate.
Therefore, "method" cancel the written notice to the requirements of manufacturing enterprises and amend the information reported to the administrative department for health to "communicate relevant information to the administrative department of public health at the same level when necessary".
YiXie enterprise has recalled obligation, refuse to perform a fine
"Method" regulation, medical device manufacturing enterprise is the main body responsible for product quality and safety, shall establish a sound system of medical device recall management, defect product recall in a timely manner. Enterprise and use the unit should be positive, actively cooperate with production enterprises to perform the duty of recall control and recovery of the defective product.
Recall three levels, the medical device manufacturing enterprise, recall decision level should be in 1 days, recall secondary recall should be within 3 days, level 3 should recall within 7 days, notify the relevant enterprises, the use of units or inform the user.
Recall is a kind of legal obligation, refused to recall of medical apparatus and instruments of production enterprises, according to the regulations on the supervision and administration of medical devices, the provisions of article sixty-six of the agency at or above the county level shall order correction, confiscate the illegal production, operation or use of medical apparatus and instruments; Illegal production, operation or use of medical value of less than 10000 yuan, and be fined between RMB 20000 yuan and 20000 yuan; Value of 10000 yuan of above, five times the sum of value and 10 times the fine; If the circumstances are serious, order to suspend production or business operation, until revoked by the original license issuing department registration certificate of medical equipment, medical equipment production license, medical equipment business licenses.
Business, refused to cooperate with related units used medical equipment defect investigation, refused to assist production enterprise of medical device recall, a warning shall be issued, instruct deadline to correct, Overdue refuses to correct, a fine of less than 30000 RMB yuan. |
