Medical network on December 14th - note, inspection and quarantine department is stepping up to imports of second-hand, refurbished, unqualified medical instruments investigation dynamics.
On November 29, general administration of quality supervision, inspection and quarantine, issued the warning notice of import of used medical equipment, and ordered local inspection and quarantine institutions to strengthen supervision on imported medical instruments.
Notice said that since 2016, Shanghai, shaanxi, guangdong, shenzhen inspection and quarantine bureau repeatedly found suspected countries banned the import of "old filling the new" old medical apparatus and instruments. The relevant inspection and quarantine bureau to the occurrences of the unqualified products processing.
To protect consumer safety in our country, according to the import and export commodity inspection and its implementing regulations and other laws and regulations, release of import of used medical instrument risk warning notice is as follows:
Around 1, inspection and quarantine institution shall increase of imported medical equipment validation information related products, mainly to verify whether the import medical device registration certificate, such as the relative import products in doubt, should be promptly with the certificate holder or overseas manufacturers to verify product information.
2, the consignee, and use the unit should conscientiously abide by the state relevant laws and regulations require import medical devices, clarify the goods source, it is strictly prohibited imports of second-hand, refurbished, old medical apparatus and instruments.
3, import medical equipment users and consumers should improve product recognition, for the purchase of medical apparatus and instruments should verify import medical device registration certificate and the corresponding certificate for inspection and quarantine of entry goods with necessary certificate holder or overseas manufacturers to verify the product information. Import medical equipment users and consumers can to relevant supervision departments unqualified product information.
4, local inspection inspection institutions shall, in accordance with the "import and export commodity inspection" and relevant laws and regulations of requirements, in accordance with the law and the unqualified products to be imported, according to regulation and the agency will inform the local customs and food.
For import of used medical equipment quality supervision, inspection and quarantine issued warning notices, at least means "strike hard" to come within a certain time.
And, in fact, since this year, for the import of used medical equipment to is not only a matter of inspection and quarantine organ, and the customs anti-smuggling department.
Just last month of November 10, the national customs for the first time a massive concentrate on old medical equipment operation. By the general administration of customs anti-smuggling bureau unified command in Beijing, Shanghai, guangzhou, shenzhen, chengdu, nanjing, huangpu, dalian, chongqing, kunming, jinan and other 11 to the customs anti-smuggling bureau, in conjunction with the local public security organ, in action at the same time, a day destroyed smuggling gang, 19, caught the criminal suspect, 32, a preliminary verification involved in smuggling old medical equipment more than 400 sets, stands at about 380 million yuan.
Strengthen supervision on imported medical instruments, has become a law enforcement of relevant departments to reality. Not only that, and the system construction.
Also in this year, on September 27 to 28, the imported medical instruments inspection regulation and compulsory product authentication management reform symposium held in kunshan, jiangsu province. Quality supervision, inspection and quarantine inspection division, certification by state certification and accreditation administration, Chinese academy of inspection and quarantine and inspection and quarantine bureau directly under 25 related personnel, a total of more than 50 representatives and experts attended the meeting.
Discussed at the meeting, the draft has been completed the monitoring of import medical instrument examination reform scheme, compulsory certification product validation work reform implementation plan, determine through "; check check, comprehensive regulatory risk classification, classification management, focus on the problem, many measures simultaneously; coordinate linkage, cooperate with "four principles, strengthen the imported medical instruments inspection regulation.
"Import medical instrument examination reform plan" and "compulsory certification product certification work reform plan" now that you have completed draft, submit for review, and released from just will take time. And with the new scheme, more to keep pace with The Times to import medical instruments will in the coming era of regulation. |
