Back to top

January Regulatory Letter

Medical Device Tax Is Permanently Repealed

Read more about this newest update here.
 

DTA / FDA Program and Regulatory Workshop
Silver Spring, MD | February 25 & 26, 2020

Manufacturers and distributors do not want to miss this exclusive access Regulatory Affairs Meeting with FDA’s Center for Devices and Radiological Health. This workshop provides a great chance for members to learn about new changes in the dental device world and to interact directly with the FDA. Learn more and register today.
 

Medical Devices; Exemptions From Premarket Notification for Class I and II Devices

Information can be found here.
 

Dental Hand Instrument; Exemptions From Premarket Notifications

Information can be found here.
 

Three Types of Premarket Notification 510(k)s May Be Submitted to FDA

Traditional; Special; and Abbreviated. The Special and Abbreviated 510(k) programs were developed in 1998 and described in the "New 510(k) Paradigm" to facilitate the 510(k) review process for certain types of submissions subject to 510(k) requirements.   In 2019, the FDA split "The New 510(k) Paradigm" into separate guidance documents; The Special 510(k) Program and The Abbreviated 510(k) Program. The Safety and Performance Based Pathway is an expansion of the concept of the Abbreviated 510(k) pathway for certain, well-understood device types.
 

European Commission Provides Guidance Documents to Assist Statekholders in Implementing Medical Device Regulations

Information can be found here.
 

European Commission Confirms 2-Year Eudamed Delay

Information can be found here.
 

European Association of Competent Authorities (CAMD) Issues Open Letter to the Medica Device Community.

You can find and read the letter here.
 

EU Medical Devices Regulation Corrections 

The Council of the European Union has published a second set of corrections as part of a corrigendum for the EU's Medical Devices Regulation (MDR), this time giving manufacturers of certain Class I devices an additional four years to comply. Learn more here.

Notified Bodies: MDR Designations

BSI Netherlands has now also been designated to the EU Regulation 2017/745 (MDR). Still relatively far away from the promise of 20 Notified Bodies by the end of 2019. As it stands, the following are the 7 Notified Bodies currently designated to this regulation:

NB Number | NB Name | Country

  • NB 0086 BSI Assurance UK Ltd United Kingdom
  • NB 2797 BSI Group The Netherlands B.V. Netherlands
  • NB 1912 DARE!! Services B.V. Netherlands
  • NB 0124 DEKRA Certification GmbH Germany
  • NB 0051 IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A. Italy
  • NB 0197 TÜV Rheinland LGA Products GmbH Germany
  • NB 0123 TÜV SÜD Product Service GmbH Zertifizierstellen Germany

NMPA (China) Announcement on Effective Implementation of Unique Identification for the First Batch of Medical Devices

Information can be found here.
 

US, Mexico, Canada Trade Agreement

Information on the USMCA can be found here.
 

World Health Organization Launches IAF's Global Database of Certifications

Validating certification in the past has been either impossible or impractical with no centralized global database. Now via the IAF (International Accreditation Forums) global database, it can be done in real-time. 
 
Users can validate an organizations certification(s) confidently knowing: 

  1. The certification is valid, 
  2. The Certification Body is accredited for the relevant standard, and;
  3. The Accreditation Body is a current IAF MLA Signatory member all in one process.

The database also provides the feature to monitor a suppliers’ certification status and send notifications if a certification of any supplier in an organization's supply chain has expired, suspended, terminated, etc which has not been possible before reducing risk amongst global supply chains.  

The database is now live consisting of:

Russian Federation Issues Regulatory Requirements Mandating Pharma Serialization and Tracing

Information can be found here.
 

ADA ISO Conference August 2020

Information can be found here.