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| July 2017 medical device registration review report |
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| Author：中國銘鉉 企劃部 Release Time：2017-8-14 10:30:45 Number Browse：628 |
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Registration acceptance
Based on the latest statistics, database of clove garden Insight in July 2017, a total of 249 accepts the device registration (according to accept order statistics), the lowest level in the first half of 2017 degrees, compared with 813 in the same period last year, to accept the amount.
In July the device registration acceptance, according to the registered classification, domestic equipment (including domestic reagent) 176, import equipment (including domestic reagent) has 538, accounts for its various than the situation as shown in the figure below:
According to the accepted number registered enterprises, most of the total number of submitted device registration in July 2017 is lanzhou institute of biological products co., LTD., a total of 29, there are two number for product registration, application type for all domestic reagent, specific data as shown in the figure below:
Data source: Insight device registration board
Special note:
1. Product registration refers to the first application of this product by the enterprise;
2. Continuous registration is the product that the enterprise has already declared. The medical device registration certificate of this product is fast approaching, and the information needs to be submitted for registration.
3. The license change refers to the product that the enterprise has already declared, the medical device registration certificate of this product and some relevant contents have changed, and the information needs to be submitted for modification.
Divided by instrument registration content, July has 49 product registration, registered 109, licensing item changes have 49, compared with June data, continue registration data dropped most registered continue in June (177).
Registered is equipment products, with the greatest impact for the future development of the enterprise, let us from two dimensions of domestic equipment and imported equipment, see July 2017 instruments registered product details.
Domestic instruments (including domestic reagents) are shown below, with 14 domestic instruments and 10 domestic reagents.
The imported instruments (including imported reagents) are shown as follows. There are 14 domestic instruments and 10 domestic reagents.
Review and approval status
In July 2017, there were 2,588 instruments registered and accepted for review. Compared with last month's 1,500, the increase, compared with the same period last year, has multiplied.
In July, the total number of registered and registered medical devices was completed, with 256 registrations and 58 registered registrations.
Special note:
1. Registered designated inspection means, a medical device at the time of product registration review, if you find that it's not the CFDA qualification cognizance of the medical apparatus and instruments, within the scope of the inspection agency can check the CFDA will according to the inspection of the applicant to apply for registration, special medical equipment inspection institutions designated to carry out registration review.
2. The license change includes the sum of the four data of the current Insight database display of the license changes, the change of the record of the specification, the change of the registration particulars and the application for change.
According to the type of application, 919 domestic instruments (including domestic reagents) that completed the review this month have a total of 1,528 imported instruments (including domestic reagents). The specific proportion is as follows:
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