Elite Biomedical Consulting
  • Home
  • Services
  • Contact
  • News
Picture

NEWS

FDA FY 2021 MDUFA User Fee(s)

1/18/2021

1 Comment

 
The following fees per application type, beginning Oct. 1, 2020 through Sept. 30, 2021, are as follows:
Picture
For eligibility of the reduced small business fee, gross receipts or sales from the most recent tax year must be under $100 million. For additional information, follow the link below to the FDA application or feel free to contact us. 
FDA SBD Guidance
1 Comment

Health Canada - Amendment of the Medical Device Regulations

1/4/2021

3 Comments

 
Health Canada has announced amendments to post-market surveillance regulations to all Medical Device License holders and Medical Device Establishment License holders.

The following provisions will come into effect on June 23, 2021:
-the power to require that a holder of a medical device licence conduct an assessment (section 62.1)
-the power to require that a holder of a medical device licence compile information, conduct tests or studies or monitor experience (62.2) 
-the requirement of the holder of a medical device authority to notify Health Canada of foreign actions taken in response to a serious risk of injury to human health (sections 61.2 to 61.3)
-the requirement to conduct issue-related analyses of safety and effectiveness (section 25(1) and section 39)

Additionally, given the new requirement to notify Health Canada of foreign actions taken in response to a serious risk of injury to human health (sections 61.2 to 61.3), the reporting of foreign incidents will no longer be required for class II-IV medical devices as of June 23, 2021.

The following provision will come into effect on December 23, 2021:
-the requirement of the holder of a medical device licence to prepare summary reports and to notify Health Canada if there has been a change to what is known about the benefits and risks (sections 61.4 to 61.6)

For additional details and access to the guidance documents, please check the link below. 
Health Canada Notice
3 Comments

    EBMC

    Stay up to date on the latest regulatory news and our latest events & updates. 

    Archives

    February 2022
    November 2021
    August 2021
    January 2021

    Categories

    All

    RSS Feed

Site Links

Home
​Services
Contact
​

Elite BioMedical Consulting, Inc.

233 Fuxing 2nd Rd., 5F, Suite 5
Zhubei City, Hsinchu County 30271, Taiwan

U.S. Branch
29122 Rancho Viejo Rd., Suite 212
San Juan Capistrano, CA 92675

Contact Information

Phone: 03-6576763
Email: [email protected]
Site powered by Weebly. Managed by FreeLogoServices.com
  • Home
  • Services
  • Contact
  • News