The Medical Device Coordination Group (MDCG) has published guidance MDCG 2021-21 “Guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices” – the document is critical for all manufacturers who manufacture and have CE marked COVID-19 tests under the IVD Directive (IVDD).

Today, WHO and HRP have launched a new guideline to help countries make faster progress, more equitably, on the screening and treatment of this devastating disease.

The landscape of the medical device industry is changing.

On Aug 7th, the U.S. Food and Drug Administration approved the first liquid biopsy companion diagnostic that also uses next-generation sequencing (NGS) technology.

October 9, with the endorsement of Premier Li Keqiang, the State Council issued the Opinions on Further Improving the Quality of Listed Companies (hereinafter referred to as the Opinions).

The Supreme Law and the National Medical Insurance Bureau issued a document: From now on, medical commercial bribery cases will be notified to the Medical Insurance Bureau

FDA will not require developers to submit a premarket approval application, premarket notification or emergency use authorization for laboratory developed tests, the Department of Health and Human Services announced on August 19th.

FDA Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID19) Diagnostic Tests

On February 7, 2014, China Food and Drug Administration (CFDA) issued the Special Review and Approval Procedure for Innovative Medical Devices (interim), which will be put into force as of March 1, 2014.

In order to safeguard the legitimate rights and interests of the applicants, CFDA drafted the Measures for the Administration of the Examination and Approval of the Confidentiality of Medicine and Medicinal Devices

In order to implement the "Medical Device Supervision and Management Ordinance" (State Council Decree No. 650) and the "Opinion of the State Council on the reform of drug and medical device review

In order to implement the Opinions of the State Council on the Reform of Examination and Approval System for Medicine and Medical Devices (Guo Fa [2015] No. 44)

A. The Direction for the Application Form of Registration 1.All the contents filled in shall be in both Chinese and English； 2.Upon the application, the form shall be printed ；

Chapter I General Provisions Article 1 These Regulations are hereby formulated with a view to strengthening the supervision and administration of medical devices, ensuring their safety and effectiveness and protecting human health and life safety.

1.The Direction for the Application Form for Registration 1) All the contents shall be in both Chinese and English； 2) All the contents must be printed；