Consultant Service
SA 8000:2014 - Social Accountability Consultant Service
₹ 5,000/DayGet Latest Price
| Service Location | India |
| Service Mode | Online |
| Delivery Time | 7 Days |
| Payment Time | Online Offline |
| Warranty | 1 Year |
- We Are Providing SA 8000:2014 - Social Accountability Service.
- Elements of the SA8000® Standard
- Child Labor
- Forced or Compulsory Labor
- Health and Safety
- Freedom of Association and Right to Collective Bargaining
- Discrimination
- Disciplinary Practices
- Working Hours
- Remuneration
- Management System
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Medical Device Regulatory Consultant Service
₹ 5,000/DayGet Latest Price
| Service Location | India |
| Type of Services | Medical Device Regulatory Consultant Service |
| Delivery Time | 7 Days |
| Service Time | Online |
| Payment Mode | Online/Offline |
| Warranty | 1 Year |
To legally manufacture, import, distribute, or sell medical devices in Canada, you must register with Health Canada under one or both of the following license types:
MDL – Medical Device Licence (for Class II, III, and IV devices)
MDEL – Medical Device Establishment Licence (for importers, distributors, and some manufacturers)
At Vericert, we provide end-to-end consulting and registration services to help you comply with Canada's Medical Devices Regulations and access the Canadian market smoothly.
- What is an MDL (Medical Device Licence)?Issued by Health Canada, the MDL is required for companies intending to sell Class II, III, or IV devices in Canada. Class I devices do not require an MDL but are subject to MDEL.
- MDL Services We Offer:Device classification assessment
Preparation of:
- Device Label and IFU (in English & French)
- Safety & Effectiveness data
- ISO 13485:2016 Certificate
- Canadian Medical Device Regulations (CMDR) compliance
- Submission of MDL application to Health Canada
- Ongoing support for license amendments or renewals
An MDEL is required by any company importing, distributing, or selling medical devices in Canada, including Class I devices.
MDEL Services We Offer:
Establishment classification and eligibility check
Preparation of:
- Quality procedures & SOPs
- MDEL Application form
- Establishment contact and structure details
- Submission to Health Canada and tracking
- Annual renewal and compliance support
- Audit readiness documentation (MDEL holders may be inspected by Health Canada)
- 100% Health Canada compliant documentation
- ISO 13485 and CMDR expertise
- Affordable support for startups and exporters
- Transparent timelines and fixed pricing
- Support for both foreign and Canadian companies
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Medical Device Turnkey Project Consultant Service
₹ 5,000/ProjectGet Latest Price
| Service Location | India |
| Type of Service | Individual Consultant |
| Mode of Service | Online |
| Time Duration | 15 Days |
| Also Provide | Turkey Project Consultant |
Regulatory Licensing & Compliance
CDSCO Medical Device Manufacturing License (Class A to D)
Drug Manufacturing License (Form 25/28/29)
Site Master File (SMF), Device Master File (DMF)
CE Marking, ISO 13485, WHO-GMP, USFDA assistance
NSWS/CDSCO Portal Registration & Approval
2️⃣ Factory & Facility Setup
Plant layout & architectural drawings (GMP-compliant)
HVAC, cleanroom, water system, ETP/STP design
Civil construction and finishing
Utility setup (compressors, chillers, gensets)
3️⃣ Machinery & Equipment Supply
Sourcing, installation & qualification of:
Blister packing, autoclaves, filling machines, etc.
Sterilizers, labeling, tablet/capsule machines
Nonwoven machinery for masks/gowns/gloves
Medical device assembly & packaging units
4️⃣ Documentation & Quality Systems
SOPs, Quality Manual, Validation Protocols (IQ/OQ/PQ)
Risk Management File (ISO 14971), Technical File
Batch Manufacturing Records (BMR)
Training, CAPA, change control, deviation handling templates
5️⃣ Product Registration & Launch
Product dossier preparation
IVD/medical device import or manufacturing approvals
Trademark, packaging, label design
Third-party testing and stability studies
🚀 Industries We Serve
Medical Devices (Disposables, IVDs, Implants, Catheters)
Pharmaceuticals (Tablets, Capsules, Injectables, Syrups)
Cosmetics & Disinfectants (Licensable under CDSCO)
Ayurveda/Herbal/Nutraceuticals (FSSAI, AYUSH-compliant)
🎯 Why Choose Us?
✅ 100+ Turnkey Projects Delivered Successfully
✅ Regulatory Experts (CDSCO, FDA, WHO)
✅ Transparent Pricing and Timelines
✅ End-to-End Execution with No Subcontract Gaps
✅ Dedicated After-Sales and Regulatory Support
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Medical Device Project Consultant Service
₹ 5,000/ProjectGet Latest Price
| Service Location | India |
| Mode of Service | Online |
| Time Duration | 10 Days |
| Type of Service Provide | Medical Licence |
| Also Gives | Medical Device Manufacturer |
CDSCO Certification Types for Medical Devices
2. Form MD-3 – Application for Manufacturing License for Class A & B Devices
3. Form MD-5 – Manufacturing License for Class A & B Devices Apply to State Licensing Authority (SLA).For domestic manufacturers of low to medium risk medical devices.
4. Form MD-7 – Application for Manufacturing License for Class C & D Devices
5. Form MD-9 – Manufacturing License for Class C & D Devices
Apply to CDSCO Head Office (Central Licensing Authority).
For domestic manufacturing of high-risk devices (e.g., cardiac stents, catheters).
6. Form MD-4 – Application for Loan License for Class A & B
7. Form MD-6 – Loan License for Class A & B Devices
When a manufacturer uses another licensed facility to manufacture.
8. Form MD-8 – Application for Loan License for Class C & D
9. Form MD-10 – Loan License for Class C & D Devices Similar purpose as MD-4/6 but for high-risk categories.1
10. Form MD-11 – Application for Import License for Medical Devices
11. Form MD-15 – Import License for Medical Devices For foreign manufacturers.
Requires appointment of an Authorized Indian Agent.
Requires:
- Free Sale Certificate (FSC)
- ISO 13485
- Device Master File (DMF)
- Plant Master File (PMF)
12. Form MD-12 – Application for Import License for IVDs
13. Form MD-16 – Import License for IVD Devices
Specifically for in-vitro diagnostics.
14. Form MD-14 – Application for Testing License
15. Form MD-18 – Testing License to Manufacture for Test or Evaluation
Required for clinical evaluation, R&D, or stability studies.
16. Form MD-17 – Application for Test License for Import
17. Form MD-19 – Test License for Import of Medical Device for Testing/Evaluation
For imported samples not for commercial sale.
18. Form MD-20 – Application for Registration of Notified Body
19. Form MD-21 – Notified Body Registration Certificate
For certification bodies performing audit of Class A & B manufacturers.
20. Form MD-22 / MD-23 – Application for Clinical Investigation of Medical Device
21. Form MD-24 / MD-25 – Permission for Clinical Investigation Applicable for new or investigational medical devices.
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