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Guidelines for Market Access of Medical Devices in China

The China Medical Device Market Access Guide is a report drafted by the Medical Device Business Department of CIRS Group, which aims to help companies and individuals who want to sell their medical devices to the People's Republic of China and register their medical device products in NMPA. This guideline describes the key definitions, main regulations, authorities and requirements for the full life cycle of medical devices in China, including pre registration preparation, registration process, testing/inspection, clinical evaluation, quality management system and post registration market management.

2022-11-09

Guidelines for Market Access of Medical Devices in China

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There are many positive factors in the domestic medical machinery industry

Medical treatment is one of the three topics of people's livelihood. As an important supporting point of the medical system, the medical device industry has received more and more attention. When the concept of urbanization is gradually emphasized, the market of medical device industry has been excavated.

2022-11-09

There are many positive factors in the domestic medical machinery industry

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Past and present life of stapler

The square column shaped staples with a cross section similar to a rectangle contact a plane with the nail pusher plate, so as to avoid the offset or distortion of the nail legs when the nail pusher plate moves.

2022-11-09

Past and present life of stapler

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Common types and applications of staplers

Two rows of spaced staples are provided to close the tissue in a straight line without cutting function. It is applicable to thoracic surgery, gastrointestinal surgery, hepatobiliary surgery, such as the operation of the lung lump, main bronchus, portal vein, pancreatic head and distal rectum.

2022-11-09

Common types and applications of staplers

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Changzhou Inspection Branch held an interview with stapler manufacturers

Changzhou has 53 stapler manufacturers, accounting for about 60% of the province. In order to further implement the main responsibility of manufacturers and strengthen the risk prevention and control in the production process of medical devices, Changzhou Inspection Branch organized a collective interview meeting for stapler manufacturers on October 27. More than 100 people including the legal representative, the person in charge of the enterprise and the management representative of the production enterprise attended the meeting.

2022-11-09

Changzhou Inspection Branch held an interview with stapler manufacturers

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10 Billion Stapler Market in the Micro invasive Era

Stapler has great advantages over traditional manual suture in surgery, and is widely used in thoracic surgery, gastrointestinal surgery, hepatobiliary surgery, urology and other surgical fields. As the number of operations in China continues to grow and the penetration rate of minimally invasive surgery continues to increase, the bank predicts that the market size of staplers in China in 2022 will be 10.929 billion yuan, and it is expected to reach 14.058 billion yuan (CAGR=8.8%) in 2025, with a compound growth rate higher than the global average. As the mainstream variety of minimally invasive surgery, endoscopic staplers will develop rapidly in the future with broad market space.

2022-11-09

10 Billion Stapler Market in the Micro invasive Era

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How to judge the equivalence of medical devices

The equivalence demonstration is a process to judge whether the declared product is equivalent to the selected comparison medical device. If the comparison product can prove that it is basically equivalent to the declared product through demonstration, the comparison product can be regarded as the equivalent product of the declared product, and clinical evaluation of the same variety can be conducted.

2022-11-09

How to judge the equivalence of medical devices

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Use zebra guide wire what you need to pay attention to

Intheprevioushowtocorrectlyusezebraguidewirecontent,wehaveintroducedtheuseofzebraguidewire.Nextwewillfocusontheuseoftheprocessforeveryonetotell. Ifthesethingshappen,weshouldnotusezebraguidewireagain.F

2017-12-20

Use zebra guide wire what you need to pay attention to

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Biopsy forceps manufacturers recommend biopsy forceps for you

Inthepreviousbiopsyforcepsmanufacturers:BiopsyforcepsWhatarethecharacteristicsofcontent,weintroducedthecharacteristicsofthebiopsyforcepsslightlyfromtheshapeandstructure.Thefollowingcontentsofourbiopsy

2017-12-20

Biopsy forceps manufacturers recommend biopsy forceps for you

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One-time use of pouch stapler product features

One-timeusepouchstaplerproductfeatures 1,withouthandsewing,reducethedamagetothesurroundingtissue.2,walletfiredabarrage,easytooperate.3,trauma,significantlyreducetheoperationtime.4,usuallyusedinone-tim

2017-12-20

One-time use of pouch stapler product features

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