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Diagnostic Kits Regulatory Services

Diagnostic Kits Regulatory Services

We offer end-to-end regulatory support for Diagnostic Kits in India starting from procuring the manufacturing licenses from CLAA and SLA for notified and non-notified medical devices, to securing registration and import licenses for imported Diagnostic Kits. Procedures for acquiring test licenses and import licenses for new diagnostic kits are also handled by our team of experts. We assist our clients in providing responses to clarifications asked from CDSCO. Our personnel with in-depth knowledge backs our clients in analyzing the parameters required for Performance Evaluation from NIB making a strong documentation support for the application which reduces chances of rejections at any stage practically nil.

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  • For Manufacturer
  • Manufacturing License for Notified Diagnostic Kits from CLAA
  • Manufacturing License for Non – Notified Diagnostic Kits from SLA
  • Test License for New Diagnostic Kits (Notified/ Non-Notified) Form SLA
  • For Importers
  • Registration of Notified Diagnostic Kits
  • Test License ( Form 11)
  • Import License for Notified Diagnostic Kits
  • Import License for Non- Notified Diagnostic Kits

For Manufacturer

We provide support and guidance to manufacturers of Diagnostic Kits through a systematic strategy, enabling in obtaining license approvals faster without undue delays at any step.

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manufacturing license from claa/ sla

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Manufacturing License for notified diagnostic kits from CLAA

The companies intending to manufacture notified diagnostic kits require a prior license from Central License Approving Authority (CLAA). We assist our clients throughout the process of filing the application which enables them to obtain the license swiftly and focus their energies on manufacturing and launch. Let our professionals handle the legislature for you.

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Manufacturing License for non-notified diagnostic kits from SLA

The manufacturing of non-notified diagnostic kits requires that the manufacturer obtain a license from the State Licensing Authority (SLA) prior to manufacturing. We assist our clients in the procurement of the license in time.

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Test License for New Diagnostic Kits (Notified/Non-notified) from SLA

To obtain the Manufacturing License for Diagnostic Kits, immense data generation is required. To generate this data for testing purpose, application for Test License is required to be filed at State Licensing Authority (SLA). It is obtained in Form 29. We help our clients in acquiring the Test License via submission of all the necessary documents and regularly following up till the license is obtained.

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For Importers

Providing support and guiding the importers to India, at CliniExperts we help our clients for a rapid and seamless launch of Diagnostic Kitsin the massive Indian market.

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Registration Process for Import of Diagnostic kits/ import license

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Registration of Notified Diagnostic Kits

For the import of Notified Diagnostic kits and its reagents in India, a Registration Certificate (Form 41) is mandatory. We offer assistance to our clients throughout the process of obtaining the Registration certificate.

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Test License ( Form 11)

The Test License (Form 11) allows import of small quantitiesof Diagnostic kits, for the purpose of examination, tests or analysis. These imported kits cannot be used for any commercial purposes. We at CliniExperts provide support to our clients in the filling of Form 11 which enables the procurement of the Test License.

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Import License for Notified Diagnostic Kits

An Import License (Form 10) is required for the import of Notified Diagnostic Kits. The filing and documentation required for the license is carefully monitored by our team of experts. The forms include Form 9 and Annexure II.

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Import License for Non-Notified Diagnostic Kits

An Import License (Form 10) is required for the import of Non-Notified Diagnostic Kits as well. The filing and documentation required for the license is carefully monitored by our expert team at every step so that any kinks are ironed out right at the outset.

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Clarification Regarding Diagnostic Kits From Cdsco

The CDCSO (Central Drug Standard Control Organization) controls the Diagnostic Kit entry into the Indian market. CDSCO is responsible for the safety of all the diagnostic kits available in India. CliniExperts offers an effective communicative strategy between CDSCO employees and clients thereby facilitating flow of information between the organization and the client. Any clarification regarding the product is effectively analyzed, addressed and solved.

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Performance Evaluation From Nib

NIB (National Institute of Biological) is in charge of Quality Management System which ensures quality evaluation of diagnostic kits for safeguarding public health in India. We at CliniExperts support our clients in obtaining the Certificate of Analysis (COA) for their Diagnostic Kits from NIB which in turn is used for filing the application for Registration Certificate and License.

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Insight

India Champions e-Governance for Pharma Industry

National e-Governance plan (NeGP), launched in 2006 as initiative that Government of India has implemented to make all government services accessible online.

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Insight

Sugam – CDSCO Portal for Online Application

Indian Government has chosen to join the foray and ride the digital wave through SUGAM, launched on 14 November, 2015

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News

Self-Assessment/Audit of Unit for GMP/GLP Compliance

Diagnostic Kits Regulatory Services We offer end-to-end regulatory support for Diagnostic Kits in India starting from procuring the manufacturing licenses from CLAA and SLA for notified and non-notified medical devices, to securing registration and import licenses for imported Diagnostic Kits. Procedures for acquiring test licenses and import licenses for new […]

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Feature

Consultation on Medical Device and Diagnostic Kit for India Market

Import and Registration of Medical Devices, Registration certificate of Critical / Notified Diagnostic Kits, Test licence for Medical Device and Diagnostic Kits, Import License for Diagnostic Kits, Manufacturing licence for medical device, Clinical Trial Approval for Medical Devices and Diagnostic Kits

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