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.
Currently HIC Regulatory Compliance map consist of :
– 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.