Medical Network March 12, last November, CFDA announced the "Notice on Doing a Good Job in the Recording of Medical Device Clinical Trial Organizations" and related management methods, aiming to further promote the reform of the medical device review and approval system and standardize the clinical trial of medical devices. process. The "recording work" was officially implemented on January 1 this year.
At the same time, in order to clarify the conditions that should be met by medical institutions for filing, in order to strengthen the management of high-risk medical devices, the “recording management measures” clearly stipulates the specific work of filing:
Institutional hardware - if a clinical trial of a third type of medical device is required, it must be a professional scope (a department) of a tertiary medical institution;
Staff hardware - with advanced technical titles and participated in more than 3 medical devices or drug clinical trials;
Filing procedures - CFDA establishes a record information system, and the relevant medical institutions can obtain the record number after filing the record.
In fact, CFDA has begun to solicit opinions on the medical record system for medical equipment in April 2015 (Letter on Soliciting Opinions on the Relevant Matters Concerning Medical Device Clinical Trial Recording) (Food and Drug Administration Regulations [2015] No. 25). The “Registration Management Measures” issued this time is the implementation of the requirements for the filing management of the medical device clinical trial institutions and the cancellation of the “Qualification Certification for Medical Device Clinical Trials” by the General Office of the CPC Central Committee and the General Office of the State Council.
In order to ensure the further development of clinical trial work, CFDA stipulates that from January 1, 2018 to December 31, 2018, the transition period, from January 1, 2019, medical devices (including in vitro diagnostic reagents) The clinical trial sponsor should select the clinical device clinical laboratory that has been filed in the filing system and conduct clinical trials in accordance with relevant requirements.
The clinical trials of medical devices have been gradually standardized, and medical institutions that have successfully filed records have also blossomed throughout the country.
As of March 9, 2018, the number of medical institutions that have successfully filed medical device clinical trial institutions has increased to 41, including the largest in Guangdong, 9 in Shanghai, 4 in Shandong, and 3 in Beijing. 3 in Fujian, 3 in Hubei, 2 in Tianjin, 2 in Sichuan, 2 in Liaoning, 1 in Jiangxi, 1 in Zhejiang, 1 in Chongqing, 1 in Jiangsu, 1 in Shanxi, 1 in Hunan Province and 1 in Inner Mongolia Autonomous Region.
Clinical specialty departments include internal medicine, surgery, pediatrics, obstetrics and gynecology, imaging and laboratory.

Sexually Transmitted Disease Tests

If your sexual history and current signs and symptoms suggest that you have a sexually transmitted disease (STD) or a sexually transmitted infection (STI), your doctor will do a physical or pelvic exam to look for signs of infection, such as a rash, warts or discharge.
Laboratory tests can identify the cause and detect coinfections you might also have.
Blood tests.Blood tests can confirm the diagnosis of HIV or later stages of syphilis.
Urine samples.Some STIs can be confirmed with a urine sample.
Fluid samples.If you have open genital sores, your doctor may test fluid and samples from the sores to diagnose the type of infection.

It include the HIV 1/2 Test, Anti-syphilis test, Gonorrhea antigen test, Chlamydia Trachomatics antigen & antibody test.


The reagent is used to detect the Chlamydia trachomatis antigen
in female cervical swab and male urethral swab qualitatively.
Chlamydia trachomatis (Ct) is a kind of microorganism in the cell,
which can infect the eye, the reproductive tract and other organs.
Chlamydia is an important pathogen for causing urethritis and
cervicitis. The ill population is mainly young adults. The
incubation period of Ct is several days to several months, usually
1 to 3 weeks. In fact, 70% to 80% of women and 50% of men
among the infected patients show no clinical symptoms, so that
it is important to have a laboratory diagnosis.
Immunochromatography detection of Chlamydia trachomatis is
widely used in clinical diagnosis for its simple operation and
quickness comparing to culture method and nucleic acid
sequence-based amplification.


Sexually Transmitted Disease Tests,Hiv Test,Chlamydia Trachomatis Test,Syphilis Test,Gonorrhea Antigen Test

Changchun ZYF science and technology CO.,LTD , https://www.zyf-medical.com