• 2020-02-12 15:58:33

For the registration of any medical device with most regulatory authorities around the world, the first step would be to prepare the device’s technical documentation or a dossier. Technical documentation are the documented evidence, normally an output of the quality management system,

• 2020-02-12 15:58:33

For the registration of any medical device with most regulatory authorities around the world, the first step would be to prepare the device’s technical documentation or a dossier. Technical documentation are the documented evidence, normally an output of the quality management system,

• 2020-02-14 04:03:25

海外医機器技術協力会(OMETA), Japan Association of Medical Device Industry (JAMDI), DEKRA Japan, and Qualtech Japan are jointly organising an upcoming seminar in early July (July 6th, 2018) in Japan.

• 2020-02-14 04:02:32

Large medical equipment is a special type of equipment with complex technology, large capital investment and high operational cost, creating a great impact on medical expenses. This April, China government has issued “The New Acceptance Catalogue for Large Medical Equipment”.

• 2020-02-14 04:01:45

The Hainan Government has issued “the Supervision Regulation of Emergency Medical Devices in Hainan International Tourism Area”, which shall be applicable for the importation and approval of medical equipment urgently needed in the clinical setting.

• 2020-02-14 04:00:29

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” (hereinafter referred to as the Guideline) in June.

• 2020-02-14 03:59:43

In early June, CNDA had 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. In this regard, CNDA is currently accepting comments from the public until the end of June 2018.

• 2020-02-14 03:58:45

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. This draft is open for public comments until July 24.

• 2020-02-14 03:57:58

CNDA welcomes public comments on the recently drafted policy entitled, "Principles of the Clinical Trial Inspection for Medical Devices", hereby referred to as "Principle".

• 2020-02-14 03:56:57

MDCO has revised guidance document related to Importer Listing in Hong Kong, that are GN-07 Guidance Notes for Listing of Importers of Medical Devices, COP-04 Code of Practice for Listed Importers of Medical Devices, and Application for Inclusion on the List of Importers/ Distributors (Form MD-IP+D). This new guidance will be fully implemented start from June 1st 2018.