MDR and Country Registration Update

We are pleased to announce an increase in our certifications under the MDR and excited to share our updated certifications below:

European Union:
Eleven (11) product families certified to the Medical Devices Regulation 2017/745 (MDR) and sixteen (16) in process.

United States:
Thirty (30) product families certified to the Code of Federal Regulations Title 21.

United Kingdom:
Thirty-nine (39) CE certified product families registered with MHRA according to The Medical Devices Regulations 2002 and transitional arrangements.

Switzerland:
Forty-eight (48) CE certified product families were appointed Ch-REP and importer according to the Medical Devices Ordinance (MedDO) and transitional arrangements, and ten (10) in process.

Saudi Arabia:
Eleven (11) product families certified to the MDS – REQ 1 – Requirements for Medical Devices Marketing Authorization.

United Arab Emirates:
One product family certified to the Federal Law No. 8 of 2019 and one in process.

Kuwait:
One product family in process for certification to the Ministerial Decree for Registration and Release of Medical Devices (MD 13/2022)

OMAN:
One product family in process for certification to the Royal Decree 35/2015, Ministerial Decision 113/2020

Jordan:
One product family certified to the Directives for the Trade of Medical Supplies, Sterilizers and Disinfectants 2019

Japan:
One product family certified to the Pharmaceutical and Medical Device Act (PMD) and more than 10 families in process.

Canada:
One product family certified to the Medical Devices Regulations (SOR/98-282) and one in process.

Australia:
Twenty-three (23) product families certified to the Therapeutic Goods (Medical Devices) Regulations 2002 and eight (8) in process.

New Zealand:
Six (6) product families certified to the Medicines Act 1981.

Mexico:
One product family in process for certification to the General Health Law

Ecuador:
One product family in process for certification to Health Law No. 67

Turkey:
One product family in process for certification to the Medical Device Regulation (Official Gazette No. 31499)

China:
Thirty-two (32) product families certified to the Regulations for the Supervision and Administration of Medical Devices (State Council Order No.739) and Thirty-four (34) in process.

Taiwan:
Three (3) product families certified to the Medical Devices Act and nine(9) in process.

Indonesia:
One product family in process for certification to Health Law No. 62 / 2017.

Singapore:
More than ten (10) product families in process for certification to the Health Products (Medical Devices) Regulations 2010.

Korea:
More than ten (10) product families in process for certification to the Medical Device Act.

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!