CDSCO Registration
The Central Drugs Standard Control Organization (CDSCO) regulates all medical devices (Class A, B, C, D), IVD diagnostic kits, pharmaceuticals, and cosmetic products in India. Any business manufacturing, importing, or distributing these products must obtain a CDSCO license on the SUGAM / MD-Online portal. We assist with medical device classification, ISO 13485 alignment, technical file preparation, test license (Form MD-13/14), and final manufacturing/import license approval.
We Take Care of Everything
From preparing your documents to training your team and supporting you during the final audit, we handle the entire process. You focus on running your business, we make sure you get certified.
What You Gain From This Certification
Here is how this certification helps your business grow and win more clients:
Mandatory for all Class A, B, C, and D medical device manufacturers and importers
Covers cosmetics import registration (Form COS-2) and manufacturing licenses
Expert assistance for SUGAM online portal filing and query resolution
Complete support for medical device master file (MDMF) and plant master file
How Long Does It Take
Standard completion schedule vs priority fast-track certificate issuance options:
Standard Timeline
1 to 3 Working Days
Express Priority Issuance
Need it faster for an urgent tender deadline or buyer audit? We expedite audit slot allocation & filing.
Documents You Will Need
ISO & compliance certifications require minimal business proof (GST or PAN). Don't worry if any paperwork is missing — our experts assist with drafting and preparing everything for you.
PAN Card & Aadhaar Card of Directors / Proprietor
Passport Size Photographs of Applicants
Proof of Business Address (Rent Agreement / Electricity Bill / Landlord NOC)
Active Bank Account Details (Cancelled Cheque or Statement)
Partnership Deed or Board Resolution / Certificate of Incorporation (if applicable)
How We Get You Certified: Step-by-Step
Here is exactly what happens from the day you contact us to the day you get your certificate:
Document Review
We verify and format all required KYC, address proof, and business details to avoid department rejections.
Application Compilation
Our compliance team drafts the government applications and double-checks for data accuracy.
Official Portal Submission
We upload all documents and submit the applications through the designated government portal (FoSCoS, MCA, DGFT, etc.).
Department Follow-ups
We track your application status daily and resolve any clarification letters or queries raised by government officers.
Certificate Dispatch
Once approved, we email your official registration certificate, license files, and registration logins.
Who Needs This?
This certification is commonly needed by businesses in these industries:
Medical Device Manufacturers & Importers
In-Vitro Diagnostics (IVD) Labs
Cosmetics & Skincare Brand Importers
Surgical & Hospital Equipment Suppliers
Why Businesses Choose Us
Here is what you can expect when you work with us:
Dedicated Audit Support
We stand with you through every step until your certificate, license, or audit report is fully approved.
Experienced Lead Auditors
Our consultants are seasoned audit specialists with over 6 years of hands-on certification experience.
No Hidden Costs
We quote flat, all-inclusive fees covering setup, consultation, coordination, and final approvals.
End-to-End Handholding
We do not just tell you what to do; we write the documents, train your staff, and handle the inspectors.
Lifetime Advisory Support
Get continuous assistance for annual surveillance audits, compliance renewals, and standard updates.
Common Questions
Answers to the questions we hear most often about this certification:
Medical device registrations are processed online through the official Online System for Medical Devices portal (cdscomdonline.gov.in) and SUGAM.
Most registrations like MSME, FSSAI, GST, and IEC require your Aadhaar card, PAN card, business address proof (electricity bill or rent agreement), and bank account details. We tell you exactly what to collect before we start.
Yes, you can update your address, add partners, or change business activities on government portals like FoSCoS, Udyam, and DGFT. We help with amendments too.
Related Standards
Other certifications and compliance standards commonly required in your sector:
Guides & Resources
Read our plain-English guides to understand more about compliance and certification: