We, Rescisco Global Regulatory consultants, intended to offer quality and regulatory services to the manufacturers of medical devices including in-vitro diagnostic medical devices from conceptualization stage to marketing as per the requirements.
Regulatory Consultation, Registrations & Licenses
Every Market Has Its Rules. We Know Them All.
Regulatory approval is not a single destination — it is a multi-market, multi-timeline strategic programme. A product approved in India may require entirely different clinical evidence for Europe, a different predicate strategy for the US, and a different quality system audit for Japan. We manage that complexity so you don't have to.
"Regulatory agencies don't just read your submission — they read between the lines. The quality of your strategy, your evidence, and your presentation signals your credibility as a manufacturer. We make sure that signal is strong."
— Rescisco Global, Regulatory Affairs Practice
India — CDSCO Services
- Medical Device Manufacturing Licence (Class A, B, C & D under MDR 2017)
- Medical Device Import Licence for all risk classes
- Test Licence for R&D and evaluation purposes
- Loan Licence for contract manufacturing arrangements
- IVD device registration and risk classification (Class A–D)
- SUGAM portal application management and query response
- In-country representation for foreign manufacturers
- New Drug / Medical Device Clinical Trial approvals
- Form MD-1 through MD-14 documentation and submission
Global Jurisdictions
CDSCO — India
MDR 2017, IMDR, IVD Rules
US FDA
510(k), De Novo, PMA, IDE
EU — Notified Bodies
MDR 2017/745, IVDR 2017/746
MHRA — UK
UKCA Marking, UK MDR 2002
TGA — Australia
ARTG Inclusion, AIMD Rules
Health Canada
MDL, MDEL, Class I–IV
ANVISA — Brazil
NOTIVISA, RDC Compliance
PMDA — Japan
Shonin/Ninsho Approval, GQP/GVP
NMPA — China
Class II/III Registration, CFDA Compliance