QH Medical

R E G U L A T O R Y S E R V I C E S

NMPA and Its departments

Medical Device

IVD products

Cosmetics

N E W S A N D R E G U L A T I ON S

06-13

2024

Announcement on the release of the Classification Catalogue of IVDs(No. 58 of 2024)

NMPA Release time: 2024-05-11In order to implement the relevant requirements of the Regulations on the Supervision and Administration of Medical Devices (State Council Decree No. 739) and further g...

06-13

2024

Announcement on standardizing the classification and definition of medical devices (No. 59 of 2024)

Release time: 2024-05-11In order to strengthen the classification management of medical devices, further standardize the classification and definition of medical devices, and optimize the working p...

06-13

2024

Notice on medical centralized procurement in 2024

Release time: 2024-05-20The Notice mainly includes four parts.1 Expand the scope of the alliance and form a national alliance for centralized procurement.2 Strengthen overall planning and coordinat...

01-08

2023

Frequently Asked Questions about the registration of medical device and IVDs in China

Below you will find answers to questions we get asked by clients the most about registering medical devices or IVDs in China.1 Where can we access Chinese standards in English?There is still no off...

03-30

2022

Interpretations of the Relevant Issues Concerning the Special Approval of Innovative Medical Device

Issued on July 31, 2017 1. Application time for the special approval of innovative medical devicesAccording to the "Innovation Procedures", if the registrant has applied for the special approval of...

03-30

2022

A Description of the Preferential Approval Procedure for Medical Devices

Issued on October 26, 2016A"medical device priority approval procedures"will be implemented on January 1, 2017,issued by the State Food and Drug Administration.17 procedures include the purpose and...

03-30

2022

Interpretation of Quality Problems in Medical Device of Clinical Trials

1. One year validitytest report of medical device registration on clinical trial “Specification for quality management of medical deviceson clinical trials," Article VII: "quality inspection report...

03-29

2022

Rules for Classification of In Vitro Diagnostic Reagent

1.In order to standardize the classification management of in vitro diagnostic reagents, these rules are formulated according to the Regulations on The Supervision and Administration of Medical Dev...