July 13, 2018

This month’s updates include the"Revision of Regulations on the Supervision and Administration of Medical Devices", “the Principles of Clinical Trial Inspection”, “a New Catalogue of Medical Devices to Be Exempted from Clinical Trials” among others. All information you need to know has been put in a nutshell:

1.    China Government issued The Measurement of Large Medical Equipment (Trial)

Following the issuance of new acceptance catalogue in mid-April, the Measurement of Large Medical Equipment has been made effective, with the objective of providing relevant guidance on Configuration, Use, and Supervision of large medical equipment across Mainland China.

Full text can be accessed here

  

2.    Hainan Government Releases “Guidelines on Emergency Medical Devices in Hainan International Tourism Area”

This article provides a short update on the added provisions of the recently published guidelines related to the emergency medical devices in Hainan International Tourism Area.

Full text can be accessed here.

  

3.    The CNDA issued the Guideline of the Submission Documents of Clinical Trial Application for Non-active Implantable Medical Devices

In order to enhance the requirements for clinical trial approval for non-active implantable medical devices, CNDA has issued “the Guidelines for the Submission Documents of Clinical Trial Application for Non-active Implantable Medical Devices”

Full text can be accessed here.

  

4.    CNDA Released a New Catalogue of Medical Devices to Be Exempted from Clinical Trials (Draft)

In early June, CNDA has issued a draft consisting of the fourth batch of medical device catalogues to be exempted from clinical trials along with the revisions of the first three batches of catalogues, in able to catch up with the upcoming classification to be implemented in July.

Full text can be accessed here.

  

5.    China's Ministry of Justice Issued "Amendments to the Regulations on the Supervision and Administration of Medical Devices (Draft)"

In order to optimize the evaluation system of medical device and encourage the innovation of medical equipment, the Ministry of Justice of China has drafted some changes on Regulation on the Supervision and Administration of Medical Devices.

Full text can be accessed here.

  

6.    CNDA Released the Principles of Clinical Trial Inspection of Medical Device (Draft)

CNDA currently accepts public opinions on the “Principles of the Clinical Trial Inspection for Medical Devices”, which was drafted in order to strengthen regulations on clinical trial operations for medical devices.

Full text can be accessed here.

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