MRDX REGULATORY · MANUFACTURER SUPPORT
BIS & FMCS certification support A focused starting point for regulated-market entry.
PAT H WAY S
SUPPORT MODEL
BIS · ISI Mark · FMCS
Application → certificate
MRDX Regulatory helps manufacturers choose the right compliance path Manufacturers do not all enter regulated markets through the same route. MRDX Regulatory presents two focused starting points, then helps orient the next compliance conversation.
PATH 01
PATH 02
STARTING POINT
Support for Indian product certification requirements.
A dedicated service for foreign manufacturers.
Begin by matching the product and marketentry need to the relevant route.
BIS certification Consultants & ISI Mark
FMCS registration
One focused conversation
02
The support runs from application to certificate MRDXRegulatory describes an end-to-end consulting role: prepare the submission, keep questions moving, and follow the regulatory journey through certificate issuance.
Prepare
Submit
Shape the application around the selected route.
Move the required materials into government review.
Resolve
Issue
Support query resolution and follow-up.
Track the path through certificate issuance.
SERVICE PROMISE · END-TO-END CONSULTING · FAST-TRACK PROCESSING POSITIONED AS PART OF THE OFFER 03
BIS and FMCS sit inside a broader approval ecosystem Certificationis oftenonepartofamanufacturer’smarket-entrywork.MRDXRegulatorylistsadjacentpathwaysacrosscertification, quality, product testing and sector-specific registrations.
CERTIFICATION
QUALITY & PRODUCT
BIS · FMCS · CE · CRS
ISO 13485 · RF · CLINICAL
ADJACENT REGISTRATIONS
BIS Certification & ISI Mark, FMCS Registration, CE Marking and CRS Registration.
ISO 13485, RF Testing and Clinical Trial Approvals.
Drug and Cosmetic registrations alongside CDSCO, FSSAI, AYUSH and EPR pathways.
CDSCO · FSSAI · AYUSH · EPR
THE RIGHT ROUTE DEPENDS ON THE PRODUCT, MARKET AND REGULATORY SCOPE. 04
One regulatory partner across multiple industries Theservicemixspansregulatedproductcategories,allowingmanufacturerstostartwiththesectorcontextrather than a disconnected filing request.
HEALTHCARE
INDUSTRIAL
Medical devices & pharmaceuticals
CONSUMER & WELLNESS
Cosmetics, food & AYUSH
Environmental compliance & chemicals
Support for manufacturers navigating healthcare-related approvals.
Sector-specific pathways across consumer and traditional health products.
Regulatory support for industrial and environmental requirements.
PAN-INDIA COVERAGE · DELHI · NOIDA · MUMBAI · BENGALURU · CHENNAI · AHMEDABAD · PUNE 05
A clear working sequence keeps certification moving Ownershipbecomeseasiertoseewhentheworkistreatedasasequenceofdecisionsandhandoffs—notasoneopaque application event.
01
Clarify route Product scope and applicable BIS or FMCS path.
02
Prepare file Required application materials assembled.
03
04
Resolve queries
Track issuance
Government questions answered and followed up.
Submission followed through certificate issuance.
Working principle: make the next handoff visible before the current one stalls. 06
Published credentials give manufacturers a starting signal MRDX Regulatory presents the credentials on its site. They can help begin diligence conversations, but they do not replace product-specific eligibility reviews.
CREDENTIAL 01
CREDENTIAL 02
CDSCO
NABL
CREDENTIAL 03
BIS Certified
Approved
Accredited
Read the signal correctly. Published credentials establish a starting point for discussion; the relevant product, standard, documentation and eligibility still need to be reviewed. 07
NEXT STEP · MANUFACTURER INTAKE
Start with a compliance conversation Bring the product, target market and current documentation. Begin by clarifying the route.
PHONE
+91 72178 05020
info@medregx.com
HOURS
LOCATION
Mon–Sat · 9:00 AM–6:00 PM IST
Dadri · Gautam Buddha Nagar · Delhi NCR