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Existing Company Modification Central Drugs Standard Control Organization, Location: India

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Type Of Industry / Business CENTRAL DRUGS STANDARD CONTROL ORGANIZATION
Location INDIA
Type Of Service Existing company modification
Project Duration 40 Days
Number Of Employees 25-50
Minimum Order Quantity 1
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Aleph Accreditation And Testing Centre Private Limited

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Product Specification

Type Of Industry / Business CENTRAL DRUGS STANDARD CONTROL ORGANIZATION
Location INDIA
Type Of Service Existing company modification
Project Duration 40 Days
Number Of Employees 25-50
Minimum Order Quantity 1

Product Description

The Central Drugs Standard Control Organization (CDSCO) under Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India is the National Regulatory Authority (NRA) of India.

All Medical Devices including an instrument, apparatus, appliance, implant, material or other article, whether used alone or in combination, including a software or an accessory, intended by its manufacturer to be used specially for human beings or animals which does not achieve the primary intended action in or on human body or animals by any pharmacological or metabolic means, but which may assisted in its intended function by such means for one or more of the specific purpose of:-

  1. Diagnosis, prevention, monitoring, treatment or alleviation of any disease or disorder;
  2. Diagnosis, monitoring, treatment, alleviation or assistance for, any injury or disability;
  3. Investigation, replacement or modification or support of the anatomy or of a physiological process;
  4. Supporting or sustaining life;
  5. Disinfection of Medical Devices
  6. Control of conception”
PROCEDURE FOR CDSCO REGISTRATION

Before applying for a CDSCO Certification of a medical product in India, it is recommended you carefully search the CDSCO announcements for specific information regarding your product first. The authority may additionally consult more detailed BIS Standards and decide based on those, whether a product shall be approved or not.

The manufacturer is not allowed to file the CDSCO approval application for import or even import his products by himself. Manufacturers are required to name an Authorized Indian Representative (AIR) to represent them in all dealings with the authority CDSCO in India. This AIR must have a valid wholesale license to be eligible to apply for an import license.

For each product risk class (A, B, C, or D) there are different CDSCO accreditation application requirements for both the manufacturer and the importer.

The application will likely require certain application forms, manufacturer information, technical data sheets, ISO certificates, IFU, test reports, clinical data as well as the accreditation in the country of origin. All documents will need to be available in English.

It is up to the CDSCO to decide whether it wants to conduct an inspection of your factory. Generally, such an audit is required if your product is not yet approved in your own market. When this factory inspection should be done is different for each risk level.

In some cases the certification authorities also request for a personal technical presentation at the CDSCO to better understand the product. At this meeting a technical representative of the company as well as the Authorized Indian Representative (AIR) are required to appear in person.

New product types will undergo a review by the Subject Expert Committee (SEC) or could be put to further tests if it is a special innovation (new technology, new material, new application). Clinical data in India could also be requested ahead of CDSCO Approval

Products within risk class A can be imported immediately and only have to be tested within 4 months after the initial CDSCO registration. Products of risk classes B, C and D are required to be tested prior to import. If required, factory inspections for risk levels A & B can be done after approval and import, for risk levels C & D they however need to be done before. For products of risk class D, only the National Institute of Biologicals (NIB) in India is accredited to conduct tests.

For some in-vitro devices a test report from an appropriately accredited test lab in another large regulated market can be accepted.

After the successful completion of all steps of the CDSCO certification of medical products in India, 

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Existing Company Modification Central Drugs Standard Control Organization, Location: India

About the Company

Year of Establishment2009
Legal Status of FirmLimited Company (Ltd./Pvt.Ltd.)
Nature of BusinessService Provider
Number of Employees51 to 100 People
Annual TurnoverRs. 5 - 10 Crore
IndiaMART Member SinceApr 2015
GST07AASCA4737B1ZO
Import Export Code (IEC)AASCA*****

Incorporated in the year 2009, and reformed in 2019 Aleph Accreditation & Testing Centre (P) Ltd widely known as "Aleph INDIA" has carved a niche amongst the trusted names in the market of Technical Certification & Regulatory Compliance in Indian Market. The motive of Aleph INDIA is to provide a single-window for all kinds of Technical Certification & Regulatory Compliance. The ownership type of our company is Pvt Ltd. The head office of the business is located in New Delhi, INDIA. Leveraging the skills of our qualified team of professionals, we are expertise in BIS Registration, WPC Approval, ISI Certification, Brand Representation, Make in India Support, Joint Venture, Collaboration Services and manufacturing of Laboratory Equipment. Aleph India contributes to a large extent in the business propulsion of foreign countries by registrations/certifications that are mandatory for a product to enter into the Indian market and also by representing them through a number of means. As India entry consulting firm that helps international companies and SMEs/Startups to get started their business and establish in India. We have helped companies from ab-initio to design and implement their strategy to enter and grow business in India. Our strong commitment and thorough approach help clients to expand their footprint and fulfill the vision to bring their respective products and services to India.

visit our official website for the complete scope of our services or call at +91-9990136656 for 24x7 support for all technical and certification related queries.

Why Us...?
We provide a single window for all kinds of Certifications and Testing Equipments which helps you achieve to improve your management system and thereby your quality standards. By this, you not only get a certificate but your company benefits on a whole as it starts working in a better manner. By our efforts, we have also gained the position of one of the renowned ISI CERTIFICATION BIS CONSULTANTS in INDIA. Our Aim to provide better solutions and liaison to all kinds of domestic & foreign clients in terms of IPR, Regulatory Registration, Compliance Certifications, Brand Representation, and Business Orientation Support to take their business up. The company offers the most reliable & effective means of solution to establish & grow the clients' business in the Indian Market. Our area of expertise varies from Quality Management Certification to Quality Assurance & Product Certification (BIS, UL mark, ISI mark, CE mark, CB Scheme, etc,) We also help our clients to achieve any other quality-related services. We have an esteemed client list, we are a customer-oriented / focused organization, customer focus is our prior motto.

Our Aim...!

Hustle Free Solution for all Technical Certification.

  • Cost-Effective Deal
  • Fast & Quality Services
  • Value for money.
  • Zero environmental affect
  • Quality-Related Service
  • Forward Thinking
  • Problem Solvers
  • Customer Support

Visit our official website for the complete scope of our services or call at +91-9990136656 for 24x7 support for all technical and certification related queries

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Seller Contact Details

Shipra Sharma

A-166, F/F, KR Bose Marg
New Delhi - 110091, India

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