Our growth plans are solidified by HIC’s regulatory global map. We strongly protect our Registrations and Regulatory Certifications as a basis to operate and go to global market. We are also in the forefront of any changing regulatory platforms.
We maintain regulatory certifications and are approved for sale in the following regions:
ISO 13485:2016
ISO 13485:2016 MDSAP
Canada: Medical Devices Regulations – Part 1- SOR 98/282
United States: 21 CFR 820 OR 21 CFR 820.180 and 198, 21 CFR 803, 21 CFR 806, 21 CFR 807
Medical Device Directive (EU) 93/42/EEC
Korea KFDA – Foreign Manufacture GMP Registration certificate no. 2010.
Japan MHLW – Foreign Medical Device Manufacturer Registration certificate no. BG31100026.