SFDA Announcement: Replacement of the Current MDMA System

November 1, 2019

Beginning of August, SFDA announced that the new system will replace the current MDMA system and more technical files will be required from the manufacturers to provide evidence of compliance to a certain route. Click here for the new regulations (MDS-G5). The new system will launch in October as an option for registration until beginning of 2020 where it should replace the current MDMA system. In addition to the above-mentioned documents, the manufacturer needs to provide the following:

  1. The Technical File document in which the intended use and clinical benefits are stated to each device.

  2. Post-Market Surveillance (PMS) Plan and Report for each device.

  3. Risk management report and plan

  4. Classification and compliance check list.

  5. Clinical evaluation report

  6. Post marketing clinical follow up

The expiry date of your approvals used to depend on the expiry of the manufacturer certificates maximum of 3 years. However, the new system will issue an approval for 3 years standard, and fees for review will depend on the number of items in the application. Click here for the new fees by SFDA (SFDA-MD36466).


Reference: MDMA, SFDA

 

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