New Regulations

CFDA issues 6 documents including the template for application and review form for ethical review of clinical trials of medical devices (No. 58, 2016)2016-03-29

CFDA issues Good clinical practice for medical devices (No. 25, 2016)2016-03-29

In March 23th, 2016, Good clinical practice for medical devices is issued by CFDA and National Health and Family Planning Commission and will be implemented from June 1st, 2016, to replace current regulations on clinical

CFDA Announcement Regarding the Issue of Charging Standards for the Registration of Drugs and Medical Devices (No. 53, 2015)2015-05-28

On May 27, 2015, CFDA released announcement regarding the issue of charging standards for the registration of drugs and medical devices (No. 53, 2015)

CFDA issues Measures for the Administration of Medical Device(including IVD Reagents) for Renewal2015-05-27

On March, 2015, CFDA released measures for relevant issues of documents for renewal.

CFDA issues Measures for the Administration of IVD Reagents2014-09-29

On June 27, 2014, CFDA released the Measures for the Administration of IVD Reagents, coming into force from October 1, 2014.

CFDA issues Measures for the Administration of Medical Device Registration2014-09-30

On June 27, 2014, CFDA released the Measures for the Administration of Medical Device Registration, coming into force from October 1, 2014.

CFDA announces issues about Class I MD filing2014-09-30

On May 30, 2014, CFDA issued an announcement where detailed regulation on Class I MD filing is specified.

CFDA issues guidelines for compiling MD product technical requirements2014-09-30

On May 30, 2014, CFDA issued new guidelines on MD product technical requirements, where normative requirements are made for the form and content of product technical requirements.

CFDA issues Class I MD directory2014-09-30

On May 30, 2014, CFDA issued Class I MD directory, to reorganize class I MD listed in 2002 MD catalogue and other related classification documents, where more details and additional information is provided.

CFDA announces issues about execution of MD Regulations2014-09-30

On May 23, 2014, CFDA made an announcement, to clarify administrative measures before regulations and normative documents to go with Regulations for the Supervision and Administration of Medical Devices come out.

Good News from QME 2017-11-07

Welcome to Sino-Dental exhibition in 2017 2017-05-05

QME will attend the CMEF 2017 2017-05-05

QME will attend IDS in 2017 2016-12-13

QME will attend the 2017 dental south china 2016-12-13

[QME exhibition Review] SINO-DENTAL 2016 2016-06-17

QME focus on CFDA registration and clinical trial of medical devices

QME will attend SINO-DENTAL 20162016-04-15

Welcome to SINO-DENTAL 2016, which will be held during June 9-12, 2016 at China National Convention Center (CNCC) • Beijing.

QME Will Attend the 21th Dental South China International Expo2016-02-25

Beijing QME Consulting Co., Ltd, the professional medical device registration company, will participate in the meeting from March 2th to 5th, 2016.

QME Will Attend 2016 Midwinter Meeting Hold by Chicago Dental Society2016-02-25

Beijing QME Consulting Co., Ltd, the professional medical device registration company, will participate in the meeting fromFebruary 25th to 27th, 2016. Our professionals will visit your booth and offer effective service fo

QME will Attend 2015 SINO-DENTAL Held in Beijing2015-05-27

We will attend Sino-Dental 2015 from June 9---12 in Beijing, our booth# is L57 & L58 in Hall 4A.