September 14, 2023
MDR and Country Registration Update
As a follow up to our initial post in June about receiving certification under the MDR, we are excited to also share the following regulatory accomplishments:
United Kingdom:
Thirty-nine (39) CE certified product families registered with MHRA according to The Medical Devices Regulations 2002 and transitional arrangements.
Saudi Arabia:
Eight (8) product families certified to the MDS – REQ 1 – Requirements for Medical Devices Marketing Authorization and six (6) in process.
Kuwait:
One product family in process for certification to the Ministerial Decree for Registration and Release of Medical Devices (MD 13/2022)
Jordan:
One product family certified to the Directives for the Trade of Medical Supplies, Sterilizers and Disinfectants 2019
Canada:
One product family certified to the Medical Devices Regulations (SOR/98-282)
New Zealand:
One product family certified to the Medicines Act 1981
Ecuador:
One product family in process for certification to Health Law No. 67
China:
Twenty-two (22) product families in process for certification to the Regulations for the Supervision and Administration of Medical Devices (State Council Order No.739) and seven certified.
Switzerland:
Thirty-one (31) CE certified product families were appointed Ch-REP and importer according to the Medical Devices Ordinance (MedDO) and transitional arrangements, and one in process.
United Arab Emirates:
One product family certified to the Federal Law No. 8 of 2019 and one in process.
OMAN: One product family in process for certification to the Royal Decree 35/2015, Ministerial Decision 113/2020
Japan:
One product family certified to the Pharmaceutical and Medical Device Act (PMD)
Australia:
Two product families certified to the Therapeutic Goods (Medical Devices) Regulations 2002
Mexico:
One product family in process for certification to the General Health Law
Turkey:
One product family in process for certification to the Medical Device Regulation (Official Gazette No. 31499)
Taiwan:
Three product families certified to the Medical Devices Act and nine in process.
We are committed to ensuring our products meet the highest safety and regulatory standards. Our pursuit of MDR registration and country certifications will be ongoing, so stay tuned! We’re making good progress with the product families slated for our Phase 2 and Phase 3 MDR certifications, we will keep you updated on these and all key important regulatory milestones!
