About IVD Regulations — In Vitro Diagnostic Compliance
In Vitro Diagnostic (IVD) medical devices — including blood tests, COVID tests, diagnostic reagents, and laboratory equipment — face specific regulatory requirements across Asia and globally. IVDR (EU IVD Regulation 2017/746), FDA 510(k)/De Novo for IVDs, and national registration requirements across Asian markets all require comprehensive quality and regulatory compliance.
Our IVD Regulations — In Vitro Diagnostic Compliance Services
- EU IVDR (2017/746) compliance assessment and gap analysis
- FDA 510(k) premarket notification for IVDs
- CDSCO IVD registration in India
- BPOM IVD registration in Indonesia
- NPRA IVD registration in Malaysia
- HSA IVD registration in Singapore
- Post-market surveillance (PMS) system design for IVDs
- Clinical evidence compilation for IVD market access
Why Work With ISOAsia?
ISOAsia has guided hundreds of Asian businesses through IVD Regulations — In Vitro Diagnostic Compliance and related compliance programmes. Our consultants combine deep regulatory knowledge with practical implementation experience — ensuring your certification project is completed efficiently, correctly, and to the highest standard.
Free Initial Consultation: Not sure if IVD Regulations — In Vitro Diagnostic Compliance is right for your product or business? WhatsApp our specialists for a free, no-obligation assessment of your requirements.
Frequently Asked Questions
The EU IVDR (2017/746) replaced the IVD Directive (IVDD) in 2022, with significantly stricter requirements. Most IVDs now require assessment by an EU Notified Body. Asian IVD manufacturers exporting to Europe must comply with IVDR requirements.
ISO 13485 applies to all medical devices including IVDs. For IVD-specific regulatory submissions, additional documentation per IVDR, FDA, or national IVD regulations is required. ISOAsia supports both ISO 13485 and IVD-specific regulatory submissions.