Shamkris Marketing Services Pvt. Ltd.
Shamkris Marketing Services Pvt. Ltd.
Borivali East, Mumbai, Maharashtra
GST No. 27AALCS7687M2Z8
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Pharma, Drug And Healthcare

We are a leading Consultants of nabh entry level acreditation, drug manufacturing license, who certification service and medical device import registration services (cdsco) from Mumbai, India.

NABH Entry Level Acreditation

NABH Entry Level Acreditation
  • NABH Entry Level Acreditation
  • NABH Entry Level Acreditation
  • NABH Entry Level Acreditation
  • NABH Entry Level Acreditation
  • NABH Entry Level Acreditation
  • NABH Entry Level Acreditation
  • NABH Entry Level Acreditation
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Approx. Price: Rs 2 Lakh / CertificateGet Latest Price
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Product Details:

Minimum Order Quantity1 Certificate
LocationMumbai, India
Service providingPan India & Globally
Type of service providerConsulting firm
NABHNABH Certification services
ServicesOnline & Offline

NABH Entery Level certification is Mandatory for all healthcare/Hospitals who are Taking Care of patients either in single speciality or multiple speacilaity .
Shamkris Qualified team conduct gap assessment and guide Hospital/Healthcare about compiance of requirement defined by NABH . Shamkris team support in writting Policy and SOPS as per NABH requirments and train team how to record documents .
Shamkris Team Guide healthcare in Application, Submit of documents as per NABH norms, Laison with NABH for Inspection date and also help in closure of NCR raised during assessment . 
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Drug Manufacturing License

Drug Manufacturing License
  • Drug Manufacturing License
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Approx. Price: Rs 2.5 Lakh / onwardsGet Latest Price
Drug  Manufcaturing Requires FDA license which is issued by State FDA . Process includes Lay out Plan Approval based on types of product and process involved , post lay out plan approval partition or construction of location as per approved Plan. Once Construction done Installation of Machinery and equipment including Basic GMP folloed with inspetcion from FDA license will granted 
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WHO Certification Service

WHO Certification Service
  • WHO Certification Service
  • WHO Certification Service
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Approx. Price: Rs 8 LakhGet Latest Price

WHO Certification Service is the United Nations specialized agency for Health. It is an inter-governmental organization and works in collaboration with its member states usually through the Ministries of Health. Who objective is the attainment by all people of the highest possible level of health. Who Secretariat is staffed by health professionals, other experts and support staff working at headquarters in Geneva, six regional offices and country offices.

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Medical Device Import Registration Services (CDSCO)

Medical Device Import Registration Services (CDSCO)
  • Medical Device Import Registration Services (CDSCO)
  • Medical Device Import Registration Services (CDSCO)
  • Medical Device Import Registration Services (CDSCO)
  • Medical Device Import Registration Services (CDSCO)
  • Medical Device Import Registration Services (CDSCO)
  • Medical Device Import Registration Services (CDSCO)
  • Medical Device Import Registration Services (CDSCO)
  • Medical Device Import Registration Services (CDSCO)
  • Medical Device Import Registration Services (CDSCO)
  • Medical Device Import Registration Services (CDSCO)
  • Medical Device Import Registration Services (CDSCO)
  • Medical Device Import Registration Services (CDSCO)
  • Medical Device Import Registration Services (CDSCO)
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Approx. Price: Rs 75,000 / CertificateGet Latest Price
Product Brochure

Product Details:

Type Of Service ProviderApplication,Advisory,Documentation and Liaison with dept.
Registration Service TypeMedical device Import/CDSCO
CDSCORegistration , Approval & License
ServicesOnline & Offline
Service providingPan India & Globally

License (Medical Devices and In-Vitro Medical Devices) – Import

For medical device mentioned in Annexure of eighth schedule which are notified as per Medical Devices Rule 2017. Means that medical devices importer shall be granted import license from CDSCO before import such medical devices.

For import of medical devices following form available for application and approval of licenses.

1.      Application for issue of import licence to import medical device in MD-14 and Licence to Import Medical Device in MD-15.

2.      Application for Licence to Import Medical Devices for the Purposes of Clinical Investigations or Test or Evaluation or Demonstration or Training in MD-16 and Licence to Import Medical Devices for the Purposes of Clinical Investigations or Test or Evaluation or Demonstration or Training in MD-17.

3.      Application for licence to import investigational medical devices for the purposes by a government hospital or statutory medical institution for the treatment of patients in MD-18 and Licence to import investigational medical device by a government hospital or statutory medical institution for the treatment of patients in MD-19.

4.      Application for permission to import small quantity of medical devices for personal use in MD-20 and Permission to import of small quantity of medical devices for personal use in MD-21.

5.      Application for grant of permission to import / manufacture for sale or for distribution of medical device which does not have predicate medical device in MD-26 and Permission to import or manufacture for sale or for distribution of medical device which does not have predicate medical device in MD-27.

6.      Application for grant of permission to Import or Manufacture for sale or for distribution of new in vitro diagnostic medical device in MD-28 and Permission to Import or Manufacture New In Vitro Diagnostic Medical Device in MD-29.

Consultancy Charges will be provide separately based on products.

Procedure for License to Import of Medical Devices (Import - CDSCO)

1.      Documentation – Preparation of documentation as per prerequisite document checklist and information as per Application form. For document Checklist please refer requisite form no. eg. MD-14, MD-16 etc.

2.      User id Creation – Crate user id on Sugam portal of CDSCO with required documents.

3.      Application to CDSCO – After verification of prepared documents, we will make an application to CDSCO. After application CDSCO official will review application and raising query if any.

4.      Query reply – If any addition document required or submitted document is not accepted by Central Licensing Authority. So we need to submit revised documents as per query.

5.      Grant of License – After verification of documents Central Licensing Authority shall grant import license as per application form.

Timeline of Process

After application to CDSCO – 1-2  Months.

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Shyam Sharma (Managing Director)
Shamkris Marketing Services Pvt. Ltd.
B-01, Western Edge II, Western Express Highway, Borivali East
Mumbai - 400066, Maharashtra, India
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