Service Details:
Minimum Order Quantity | 1 Unit |
Type Of Service Provider | Consulting Firm |
Type Of Industry | IT and Consulting |
Owner Of The Trademark | BIS Registration Service Provider |
Registered Period | BIS Registration within 20-25 Days |
Product Type | BIS Registration for Electronic and IT Products |
Certification Provided With in | BIS Registration within 20-25 Days |
Application Area | BIS Registration Consultant |
Duration | BIS Registration within 20-25 Days |
Type of Certification | New Certification |
Mode Of Service | Online/Offline |
Service | BIS Registration Service |
Trademark Dimensional | Trademark Registration Service Provider |
Registration Service Type | BIS Registration for Electronic and IT Products |
Additional Information:
Service Details:
Minimum Order Quantity | 1 Unit |
Service Charges | 2500+GST |
Location | Globally |
Type Of Industry | Service |
Service Location/City | ALL OVER WORLD |
Type Of Service Provider | Consultancy Service |
Import / Export Location | Pan India |
Certification | Import Licensing Services |
Product Weight / Size | 1/unit |
Service Details:
Certifications Provided | BIS |
Target Location | Pan India |
Document verification Mode | Online |
Services offered | Consultancy |
Type of Certification | New Certification |
Type of Industry | For IT and Consulting |
Mode of Report | Soft Copy |
Certification Provided with in | BIS |
Service Details:
Minimum Order Quantity | 1 Certificate |
Company Location | Delhi |
Professional Experience | 10 Years |
Type of Certification | New Certification |
Certification | Any |
Location | New Delhi |
Mode Of Service | Online/Offline |
Document Verification Mode | Online |
Duration | 20-25 Days |
Service Location | All Over the Globe |
Service | All type of product certification services |
Type of Service Provider | Consulting Firm |
Certification Provided With in | 20-25 Days |
Type Of Ownership | Partnership |
Type Of Service | New company registration |
Additional Information:
Service Details:
Minimum Order Quantity | 1 Month |
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 |
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:-
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,