Aleph Accreditation And Testing Centre Private Limited
Aleph Accreditation And Testing Centre Private Limited
New Delhi, Delhi
GST No. 07AASCA4737B1ZO
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Consultancy Services

Pioneers in the industry, we offer import licensing services, bis registration for bluetooth speaker, bis registration for all electronics accessories eg :wireless keyboards etc and central drugs standard control organization from India.

Import Licensing Services

Import Licensing Services
  • Import Licensing Services
  • Import Licensing Services
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Approx. Price: Rs 2,500 / UnitGet Latest Price
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Service Details:

Minimum Order Quantity1 Unit
Type Of IndustryService
Service Location/CityALL OVER WORLD
Type Of Service ProviderConsultancy Service
Import / Export LocationPan India
CertificationImport Licensing Services
Product Weight / Size1/unit
Service Charges2500+GST
LocationGlobally

Get hassle free Import licensing services at affordable charges in India.
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BIS Registration For Bluetooth Speaker

BIS Registration For Bluetooth Speaker
  • BIS Registration For Bluetooth Speaker
  • BIS Registration For Bluetooth Speaker
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Approx. Price: Rs 20,000 / UnitGet Latest Price
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Service Details:

Minimum Order Quantity1 Unit
Certifications ProvidedBIS
Target LocationPan India
Document verification ModeOnline
Services offeredConsultancy
Type of CertificationNew Certification
Type of IndustryFor IT and Consulting
Mode of ReportSoft Copy
Certification Provided with inBIS

All models and brands of Bluetooth Speakers are classified under IS 616 and are required to get BIS Registration before its launch or import into the Indian market. BIS Registration will be provided to the product manufacturers (whether Indian or non-Indian) only and not provided to trader, dealer or distributor of the product.
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Bis Registration For All Electronics Accessories Eg :Wireless Keyboards Etc

Bis Registration For All Electronics Accessories Eg :Wireless Keyboards Etc
  • Bis Registration For All Electronics Accessories Eg :Wireless Keyboards Etc
  • Bis Registration For All Electronics Accessories Eg :Wireless Keyboards Etc
  • Bis Registration For All Electronics Accessories Eg :Wireless Keyboards Etc
  • Bis Registration For All Electronics Accessories Eg :Wireless Keyboards Etc
  • Bis Registration For All Electronics Accessories Eg :Wireless Keyboards Etc
  • Bis Registration For All Electronics Accessories Eg :Wireless Keyboards Etc
  • Bis Registration For All Electronics Accessories Eg :Wireless Keyboards Etc
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Approx. Price: Rs 20,000 / UnitGet Latest Price
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Service Details:

Minimum Order Quantity1 Unit
Company LocationDelhi
Professional Experience10 Years
Type of CertificationNew Certification
CertificationAny
LocationNew Delhi
Mode Of ServiceOnline/Offline
Document Verification ModeOnline
Duration20-25 Days
Service LocationAll Over the Globe
ServiceAll type of product certification services
Type of Service ProviderConsulting Firm
Certification Provided With in20-25 Days
Type Of OwnershipPartnership
Type Of ServiceNew company registration

All models and brands of Wireless Keyboards are required to get BIS Registration before its launch or import to the Indian consumer market.
BIS Registration will be given to manufacturer only (not to dealer/trader or distributor) whether manufacturer is in India or in abroad does not matter. Please refer Info section for more details. All models and brands of IS 13252 (Part-1) are required to get BIS Registration before its launch or import to the Indian consumer market.
Aleph India window for all kind of technical certification and Testing Equipment. #AlephINDIA&#BIS#WPC#ETA#TAC#BEE#CE#UL#Ewaste#CPCB#CARE#ISIMark#Hallmark.
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Additional Information:

  • Pay Mode Terms: L/C (Letter of Credit),T/T (Bank Transfer),D/P,D/A,Other
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Central Drugs Standard Control Organization

Central Drugs Standard Control Organization
  • Central Drugs Standard Control Organization
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Approx. Price: Rs 20,000 / UnitGet Latest Price

Service Details:

Minimum Order Quantity1 Unit
Type Of Industry / BusinessCENTRAL DRUGS STANDARD CONTROL ORGANIZATION
LocationINDIA
Type Of ServiceExisting company modification
Project Duration40 Days
Number Of Employees25-50

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:-

  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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Shipra Sharma (Business Development Manager)
Aleph Accreditation And Testing Centre Private Limited
A-166, F/F, KR Bose Marg, Pratap Nagar
New Delhi - 110091, Delhi, India


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