Describe your thoughts on what regulations or codes each of the following clinical trials would need to comply with:
Central Venous Catheter (CVC) manufactured in the United States and sold only in Europe
Embolic coil device manufactured in the EU and sold only in the EU
Angioplasty catheter manufactured in India and sold only in India
Angioplasty catheter manufactured in India and sold in the United States
Bone void filler manufactured in Europe and sold in Canada
Spiral Medical Development
www.spiralmeddev.com
Central Venous Catheter (CVC) manufactured in the United States and sold only in Europe
Class IIb/Class III Medical Device Directive 93/42/EEC, ISO 13485, ISO14971, ISO10993, and GMPs 21 CFR 820 since its manufactured in the US. CE mark to be sold in EU
Embolic coil device manufactured in the EU and sold only in the EU
Implantable but not active, class IIa
Medical Device Directive 93/42/EEC, ISO 13485, ISO14971, ISO10993, CE mark to be sold in EU
Angioplasty catheter manufactured in India and sold only in India
Class C, S 13 per Central Drugs Standard Control Organization CDSO and ISO 13485
cdsco/medical-devices-rules-2017-classification-of-medical-devices/
Angioplasty catheter manufactured in India and sold in the United States
Class C, S 13 per CDSO and and GMPs 21 CFR 820 since its manufactured in the US
Bone void filler manufactured in Europe and sold in Canada
Class IIa Class IIb/Class III Medical Device Directive 93/42/EEC, ISO 13485, ISO14971, ISO10993 and SOR/98-282 Canadian Medical Device Regulations (CMDR) and ISO 13485
wipo/wipolex/en/text.jsp?file_id=222650