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At Silvereye Certifications, we understand that navigating through the complex Medical Devices Registration processes can be very difficult to manage, especially if you are unfamiliar with the requirements. That is why our experienced team is here to simplify it for you. From gathering the necessary documents to completing the registration process, we handle everything, ensuring you stay stress-free at every step.

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MEDICAL DEVICES REGISTRATION

COSMETIC REGISTRATION

MEDICAL DEVICES: The CDSCO (Central Drugs Standard Control Organization) plays a very crucial role in regulating the sale and operations of the medical devices in India. CDSCO (Central Drugs Standard Control Organization) is primarily responsible for the setting the standards for the safety, efficacy, and quality of the medical devices in our country. The introduction of the MDR (Medical Device Rules) 2017, which came into effect in January 2018, marked a significant step in improving the regulation and the oversight of the medical devices in India. As the part of his day-to-day framework the CDSCO (Central Drugs Standard Control Organization) introduced various kind of services and forms, among all it also included two important forms MD-41 and MD-42 are critical for regulating the sale, distribution, and storage of the various medical devices in India.

MD-41

MD-41 is the application form used by the entities seeking a registration certificate to sell, stock, exhibit, or offer for sale or distribution of Class A or Class B medical devices

MD-42

MD-42 on the other hand, is the actual registration certificate issued by the CDSCO (Central Drugs Standard Control Organization) after the successful evaluation of the application made under MD-41

TYPES OF MEDICAL DEVICES REGISTRATION

Any Indian entity who is willing to manufacture or import the medical devices has to undergo the CDSCO registration. There are various forms specified for each type of license that the applicant is opting for as per its business requirement. The list of application forms is mentioned below.

  1. IMPORTER: Any Indian entity who is willing to import medical devices from a foreign manufacturer needs to apply for the CDSCO import license under the MD-14 application form.
  2. MANUFACTURER: An Indian entity willing to manufacture and further sell medical devices in India needs to apply for a CDSCO medical device manufacturing license under Form MD-3 or Form MD-7.
APPLICATION TYPECLASS OF MDAPPLICATION FORMLICENSE FORM
IMPORTERA,B,C,DMD-14MD-15
MANUFACTURERSA BMD-3MD-5
MANUFACTURER (LOAN LICENSE)A BMD-4MD-6
MANUFACTURERC,DMD-7MD-9
MANUFACTURER (LOAN LICENSE)C,DMD-8MD-10

GOVERNMENT FEES FOR MEDICAL DEVICES REGISTRATION

For every application for the registration of the medical devices, there are separate fees imposed on them. Each application for the registration of the medical devices shall be supported with the list of documents and the requisite fee as provided in the online portal of the CDSCO.

Type of LicenseClass of DeviceApplicable RegulationGovt. Fee
For Manufacturing/Loan LicenseA or B20(2)For one site: Rs. 5,000; For each device Rs. 500
For Manufacturing/Loan LicenseC or D21(2)For one site: Rs. 50,000; For each device Rs. 500
For Import License (other than IVD)Class A34(2)For one site: 1,000 $; For each device: 50 $
Import License (other than IVD)Class B34(2)For one site: 2,000 $; For each device: 1,000 $
Import License (other than IVD)Class C or D34(2)For one site: 3,000 $; For each device: 1,500 $
Import License (in IVD)C or D34(2)For one site: 2,000 $; For each device: 500 $

WHY CHOOSE US

END TO END SUPPORT:

We offer comprehensive, end-to-end support to our clients, guiding you through every step of the process—from the creation of the portal to the final approval and issuance of your BIS license. Our commitment is to stand by your side, ensuring a smooth and hassle-free experience.

INDUSRTY EXPERTISE WITH CUSTOMER CENTRIC APPROACH

Our industry experience, combined with a highly skilled team boasting over 10 years of expertise. We pride ourselves on a customer-centric approach, personalising our services to meet your unique needs and ensuring your satisfaction at every step.

AFFORDABLE AND TRANSPARENT PRICING:

Silvereye certifications prioritizes charging customers a fair price and offering fixed pricing without any hidden fees, providing services with full transparency and trust in their functionality

GLOBAL SCOPE WITH LOCAL INSIGHT:

With a global network of seasoned experts, we simplify certifications and approvals. Our local expertise ensures seamless assistance and ongoing support for any future challenges.

INNOVATIVE SOLUTIONS WITH RELIABILITY AND TRUST:

We provide new and creative solutions you can trust. Our focus is on being reliable and building strong relationships by always delivering great results.

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