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Medical Device Registration and Approval in India (CDSCO)
Regulatory Approval Services, Quality Assurance Services & Other Services
Medical Devices Consultants in India
India Regulatory Support
Medical device consultant can provide research, regulatory, communication and product development services, so that you can launch your product in the market with confidence.
INDIA REGULATORY SUPPORT
Medical Device Registration
IVD Device Registration
Medical Device Classification
Medical Device Grouping
Predicate Device Id
My Blog
An overview of CDSCO approval process for registration
REGULATORY REGISTRATION SERVICES
REGULATORY REGISTRATION SERVICES
REGULATORY REGISTRATION SERVICES
IVD Registration
- In India, import, manufacturing, sale and distribution of In Vitro Diagnostic Medical Devices are regulated as Drug under sub-clause (i) of clause (b) of section 3 and sub-clause (iv) of clause (b) of section 3 of Drugs and Cosmetic Act and Rules
- The requirements for grant of licence to Manufacture, Import, Clinical Performance, Sale and Distribution are prescribed in MDR-2017.
- In vitro diagnostic medical devices shall be classified on the basis of risk parameters as specified in Part II of the First Schedule, as under:
- Low risk - Class A;
- Low moderate risk- Class B;
- Moderate high risk- Class C;
- High risk- Class D.
- Classification list of In Vitro Diagnostic Medical Devices have been published on the website of the Central Drugs Standard Control Organization approved by CLA.
- The Central Licensing Authority shall be the competent authority for enforcement in matters relating to:
- Import of all Classes of In Vitro Diagnostic Medical Device
- Manufacture of Class C and Class D In Vitro Diagnostic Medical Devices
- Clinical Performance evaluation and approval of new in vitro diagnostic medical devices
- Co-ordination with the State Licensing Authorities
- The State Drugs Controller, by whatever name called, shall be the State Licensing Authority and shall be the competent authority for enforcement in matters relating to-
- Manufacture for sale or distribution of Class A or Class B In Vitro Diagnostic
Medical Devices Registration
- Sale, stock, exhibit or offer for sale or distribution of In Vitro Diagnostic Medical Devices of all classes.
- Medical Devices Registration
- In India, at present only notified medical devices are regulated as Drugs under the Drugs and Cosmetics Act 1940 and Rules made thereunder in 1945.
- substances used for in vitro diagnosis and surgical dressings, surgical bandages, surgical staples, surgical sutures, ligatures, blood and blood component collection bag with or without anticoagulant covered under sub-clause (i);
- (ii) substances including mechanical contraceptives (condoms, intrauterine devices, tubal rings), disinfectants and insecticides notified under sub-clause (ii); and
- devices notified from time to time under sub-clause (iv), of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940;
Name of the Medical Device
- Disposable Hypodermic Syringes
- Disposable Hypodermic Needles
- Disposable Perfusion Sets
- In vitro Diagnostic Devices for HIV, HBsAg and HCV
- Cardiac Stents
- Drug Eluting Stents
- Catheters
- Intra Ocular Lenses
- I.V. Cannulae
- Bone Cements
- Heart Valves
- Scalp Vein
- Orthopedic Implants
- Internal Prosthetic Replacements
- Ablation Devices
IMPORT & DISTRIBUTION MANAGEMENT
REGULATORY REGISTRATION SERVICES
REGULATORY REGISTRATION SERVICES
Benefits of Indian Authorized Agent:
- Appointing Lumbar Healthtech as your Indian Agent provides clarity, confidence and control over your import, distribution and vigilance activities in India.
- Lumbar Healthtech is a full-service provider of medical device license holder services in India. Contracting with us as your India Agent allows you to:
- Sell directly to multiple regional distributors (avoiding mark-up by a national importer)
- Increase transfer pricing (as distributors are not investing in registration costs)
- Improve leverage in distributor negotiations/responses
- Add or change distributors as required
- Keep intellectual property away from local commercial agents
Lumbar Healthtech will involve taking title of the shipment through customs clearance and managing the following activities:
- Order and payment processing
- Arranging shipping (ex-works typical)
- Customs clearance
- Organizing local delivery to regional distributor’s warehouse
- Optional support services are also available such as long-term storage, break-bulk, labelling, and order fulfilment upon client’s request.
About us
REGULATORY REGISTRATION SERVICES
About us
- Lumbar Healthtech Company which is successfully import the products into India with registration.
- As an Indian Authorized Agent, Lumbar Healthtech provides high quality and professional services and develop long term relationship for the Indian market by the regulation of CDSCO for registration of the below product.
- Medical Devices
- Cosmetics
- In Vitro Diagnostics Kits
- Other requirements
Our mission is to provide a stable, reliable local platform so that our clients can grow their sales in challenging Asian markets.
We are medical devices certification consultants Company based in Chennai and we assist our clients worldwide in obtaining the certifications required on medical devices in India on their variety of products.
Some of them are Catheters, Implants, Bone Cement, Fixation Systems and etc..
Contact Us
Registered Office Address
Lumbar Healthtech Pvt Ltd
Plot# 23 VGP Prabhu Nagar Part II
2nd Street, F2 First Floor, Perumbakkam.
Chennai-600100.
Tamilnadu, India.
GST# 33AAECL5723E1ZU
Please contact -
Regulatory Department:
Phone# +91 99403 76612
+91 91760 69400
WhatsApp# +91 99403 76612
For sales in India - Distributor wanted
for sales of US ultrasound
imaging systems and
lasers from USA
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