#cdsco md online

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CDSCO stands for Central Drugs Standard Control Organization. It is the national regulatory authority for pharmaceuticals and medical devices in India. CDSCO md online is responsible for the regulation, approval, and quality control of drugs, cosmetics, medical devices, and diagnostics in the country. It operates under the Ministry of Health and Family Welfare, Government of India.

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CDSCO’s Extension: Grace Period for Class C and Class D Medical Devices

Introduction:

The CDSCO recently extended the deadline by six months for manufacturers and importers dealing with non-notified Class C and Class D medical devices. Originally scheduled for mandatory licensing from October 1, 2023, this extension aims to facilitate a smoother transition. Let’s explore the CDSCO circular and the approval procedures for these devices.

Addressing Industry Concerns:

Understanding the Licensing Process:

Registration and Licensing for Class C and D Medical Devices

The CDSCO, as the central authority, handles import and manufacturing licenses for medical devices. The process involves registering on the Sugam portal, paying fees, and submitting online applications along with necessary documentation.

Import Licensing Procedure: 1. Register on the Sugam portal. 2. Pay fees. 3. Submit Form-14 with required documents. 4. CDSCO issues Form-15 upon approval.

Manufacturing Licensing Procedure: 1. Register on the Sugam portal. 2. Pay fees. 3. Submit Form MD-7 (or MD-8 for loan licenses) with documentation. 4. Undergo a facility audit. 5. Receive Form 9 (or MD-10 for loan licenses) upon compliance.

Conclusion:

The CDSCO’s extension aims to prevent disruptions in medical device manufacturing and import. It facilitates a smoother transition to the new approval regime.

RSI’s Assistance in Navigating Regulatory Landscape:

Regulatory Solutions India (RSI) offers support to those yet to apply for Class C & D devices. With expertise in medical device regulatory affairs, RSI has aided over 450+ device registrations across various categories and countries. Services include CDSCO Medical Device Registration, Import Licensing, Wholesale/Distributor Licensing, Post Approval Changes, and Medical Device Label Compliance Review.

FAQs:

1. Eligibility for the 6-Month Extension: Applies to manufacturers and importers who applied for licenses before September 30, 2023, allowing operations until April 1, 2024.

2. Role of Form-14: Essential for obtaining an import license, requiring necessary documents alongside the application on the Sugam portal.

3. Understanding Form-15 in Import Licensing: Issued upon CDSCO’s approval of Form-14, allowing importation into India.

4. Significance of Form-7 in Manufacturing Licensing: Essential for acquiring a manufacturing license for medical devices in India.

5. Role of Form-9 in Manufacturing Process: Signifies permission for manufacturing Class C & D medical devices upon compliance and satisfactory inspection.

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CDSCO Online medical device manufacturing license

In India, the CDSCO (Central Drugs Standard Control Organisation) regulates cosmetic products and the Drugs and Cosmetics Act, 1940 regulates CDSCO Cosmetic Manufacturing License. After 2013, it became mandatory for all the imported cosmetics for sale to get registered with DCGI (Drug Control General of India); before that, there was no such provision. 

Nowadays, customers are curious to know the ingredients in products & make choices which one is good to buy. Therefore, to start a new cosmetic business and conduct manufacturing, selling, and distribution of products, you need to obtain CDSCO Cosmetic Manufacturing License first. Then, registered cosmetics will need to stick a unique label with the Registration Certificate Number on it. 

Step 1: Application for grant of Manufacturing Licence The applicant has to make application online at the CDSCO portal cdscomdonline.gov.in inrequisite form such as MD-3 (or MD-4 for loan license) for license to be issued on form MD-5, or as applicable as per the Medical Device Rules, along with necessary fees challanas given in fee chart under ‘Forms & Fees’. Fee can be paid through Government Treasurychallan, under Head of Account0210- 04-800-02-00 Other receipts Department Name: Drugs Controller, Rajasthan, Jaipur Office Name: Asstt. Drugs Controller, NDNP, Jaipur, Rajasthan Documents to be uploaded along with the application form: 1. Covering Letter 2. Application Form. 3. Receipt of fees challan 4. Constitution of firm including a. Partnership deed / Memorandum & Article of Association b. Declaration of Proprietor/ Partners/ Director(s)/ Managing Director c. List of all the Partners/ Directors with age & complete postal & residential address. 5. Documents of Site ownership / Tenancy agreement 6. Plant Master File (as per appendix I of Part III of fourth schedule) Apart from the mandatory information as per appendix I of Part III of fourth schedule, following documents should also be submitted: a. Declaration of Manufacturing Chemist. b. Declaration of Analytical Chemist. c. Documents of educational qualification, experience and approval certificates of proposed Manufacturing Chemist & Analytical Chemist; Appointment Letters; Id proof. d. Registration from District Industries Centre. e. Consent to establish & consent to operate from Rajasthan State Pollution Control Board. 7. Device Master File for each product (as per appendix II / appendix III of fourth schedule) 8. Performance Evaluation Report (if applicable) 9. Copy of Test License (if applicable). 10. Undertaking that the manufacturing site is in compliance with the provisions of Fifth Schedule. Following additional documents are required if applied for loan license on Form MD-4: 1. Consent letter from principal manufacturing unit in case of loan license. 2. Wholesale licenses of the applicant loan licensee. 3. Valid manufacturing licenses and copies of product permission of the product in question of the principal manufacturer.  

Step 2: Scrutiny of application. In case any shortcoming / discrepancy is noted, query shall be raised. Further action shall be taken upon receipt of reply of query from the applicant. In case the application is found in order, it will be processed for audit of factory premises by a notified body as per Medical Device Rules.  

Step 3: Audit of applicant premises by notified body. The non-compliances, if any, shall be rectified by the applicant. The audit report and the NC closure will be uploaded by the notified body.  

Step 4: Upon receipt of the audit report, it will be examined and if found satisfactory, it will be forwarded for the next step.  

Step 5: Products Scrutiny. The details of the products applied for shall be scrutinized and if they are found to comply with the norms, the application will be considered for grant of license.  

Step 6: Grant of Licence If all the prescribed conditions are complied with, licence is granted 

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The Central Drugs Standard Control Organisation (CDSCO) is a part of the Ministry of Health and Family Welfare, Government of India, and serves as the National Regulatory Authority. CDSCO is responsible for approving drugs, conducting clinical trials, setting standards for drugs, ensuring the quality of imported drugs, and coordinating with State Drug Control Organizations to enforce the Drugs and Cosmetics Act.

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Corpseed company is the best CDSCO Registration, license, and certificate service provider at the lowest price. CDSCO (Central Drugs Standard Control Organization) is the national regulatory body for pharmaceuticals and medical devices in India. CDSCO registration is required for any company or entity that wants to manufacture, import, or sell drugs and medical devices in India.

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As an AI language model, I do not have access to the latest news or current events. However, I can provide you with general information about import CDSCO Registration for medical devices. In many countries, including the United States, medical devices are regulated by the government, and companies that manufacture or import medical devices are required to obtain licenses or certifications before they can sell their products in the market.

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The Central Drugs Standard Control Organization (CDSCO) is the regulatory body that oversees the import of cosmetics into India. To import cosmetics into India, a company must obtain a registration certificate from CDSCO Online. Submit an application for registration to the Drugs Controller General of India (DCGI), which is a part of CDSCO. Provide the required documents, such as product information, manufacturing details, and safety data.

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The Central Drugs Standard Control Organization (CDSCO) is the national regulatory body for CDSCO medical device registration in India. Companies that want to sell medical devices in India must register with the CDSCO, and they must work with an authorized agent to do so. Choosing the right CDSCO authorized agent is important, as it can impact the success of your registration process. Here are some tips on how to choose the right CDSCO authorized agent for medical device registration:

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CDSCO, or the Central Drugs Standard Control Organization, is the national regulatory body for pharmaceuticals and medical devices in India. It is responsible for the regulation of drugs and medical devices in India, including the registration and licensing of these products. The registration process for drugs and medical devices in India is governed by the Drugs and Cosmetics Act of 1940, as well as the rules and regulations made under this Act. The CDSCO is responsible for enforcing these regulations and ensuring that drugs and medical devices are safe, effective, and of high quality.

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Central Drugs Standard Control Organisation (CDSCO) is the national regulatory body for pharmaceuticals and medical devices in India. It operates under the Ministry of Health and Family Welfare and is responsible for regulating the quality, safety, and efficacy of all drugs and medical devices in the country. CDSCO plays a critical role in ensuring that drugs and medical devices in India are safe and effective for use, and its regulations and standards are widely recognized as among the strictest in the world.

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CDSCO checklist for self assessment

The Central Drugs Standard Control Organization (CDSCO registration) is the national regulatory body responsible for approving and monitoring pharmaceutical and medical devices in India. Self-assessment is an important part of the regulatory process and helps companies ensure that they are in compliance with all relevant regulations.

Here is a general checklist for self-assessment based on CDSCO regulations:

Good Manufacturing Practices (GMP) compliance: Ensure that your manufacturing facilities are compliant with the GMP regulations set forth by the CDSCO certificate.

Quality Management System (QMS) compliance: Verify that your QMS meets the requirements set forth by the CDSCO, including documentation, risk management, and product quality control.

Licensing and Registration: Ensure that all necessary licenses and registrations are up-to-date and in compliance with the CDSCO regulations.

Clinical Trials: If you are conducting clinical trials, ensure that they are in compliance with the CDSCO regulations, including ethical standards and reporting requirements.

Adverse Event Reporting: Ensure that you have established a system for reporting adverse events, and that you are reporting them in accordance with CDSCO regulations.

Product Labeling and Packaging: Verify that your product labeling and packaging comply with the regulations set forth by the CDSCO, including language, labeling requirements, and warnings.

Import/Export Regulations: Ensure that your import and export processes are in compliance with the regulations set forth by the CDSCO online.

Compliance with Scheduled Drugs: If your product is a scheduled drug, ensure that you are in compliance with the regulations set forth by the CDSCO, including licensing, manufacturing, and distribution requirements.

Note: This list is not exhaustive and is intended only as a general guide. Companies should refer to the specific regulations set forth by the CDSCO for more detailed information.

CDSCO Registration Document Checklist for Pre-screening

The Central Drugs Standard Control Organization (CDSCO) is the national regulatory body responsible for approving and monitoring pharmaceutical and medical device import license in India. Pre-screening is the process of evaluating a company's application for registration before it is submitted to the CDSCO for review.

Here is a general checklist for pre-screening of registration documents for CDSCO:

Company Information: Ensure that all necessary company information, such as name, address, and contact information, is included and up-to-date.

Licenses and Registrations: Verify that all necessary licenses and registrations, including GMP, QMS, and clinical trial approvals, are included and up-to-date.

Product Information: Ensure that all product information, including name, composition, dosage form, and strength, is accurate and complete.

Manufacturing Information: Verify that all manufacturing information, including location, facilities, and equipment, is accurate and up-to-date.

Quality Control Information: Ensure that all quality control information, including procedures, testing methods, and specifications, is accurate and complete.

Stability data: Provide complete stability data as per the ICH guidelines for each batch of the product.

Clinical Trial Information: If the product has undergone clinical trials, ensure that the results and data are accurately and completely reported.

Product Labeling and Packaging Information: Ensure that all labeling and packaging information, including language, labeling requirements, and warnings, is accurate and compliant with CDSCO regulations.

Adverse Event Reporting: Verify that a system for reporting adverse events is in place and that the company is reporting them in accordance with CDSCO regulations.

Import/Export Regulations: Ensure that all import and export information, including customs clearance, is accurate and compliant with CDSCO regulations.

Note: This list is not exhaustive and is intended only as a general guide. Companies should refer to the specific regulations set forth by the CDSCO new drug approval for more detailed information.

CDSCO Guidance Document

The Central Drugs Standard Control Organization (CDSCO) is the national regulatory body responsible for approving and monitoring pharmaceutical and CDSCO medical device registration in India. The CDSCO provides guidance documents to help companies understand and comply with its regulations.

Here are some of the key guidance documents issued by the CDSCO:

Good Manufacturing Practices (GMP)

Read more This Blog :- CDSCO Import License for Medical Devices In India

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The Central Drugs Standard Control Organization (CDSCO) is India's national regulatory body for medical devices. An import license is required for importing medical devices CDSCO India is responsible for issuing these licenses. The importer must apply for the license, submit the necessary documents and pay the fees. The documents include information about the device, its manufacturer, testing reports, and registration certificates.

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The Central Drugs Standard Control Organization (CDSCO) is India's national regulatory body for pharmaceuticals and medical devices. It is responsible for the control and regulation of the import, manufacture, distribution, and sale of pharmaceutical and medical devices in India. The CDSCO Online ensures that these products are acceptable, safe, and effective for their intended use. The organization also provides guidelines, norms, and standards for the pharmaceutical and medical device industries to follow. It is headquartered in New Delhi and operates under the Ministry of Health and Family Welfare, Government of India.

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DCGI and CDSCO refer to the same body, the Central Drugs Standard Control Organization, which is the central drug regulatory authority in India responsible for approving drugs for marketing in the country. DCGI stands for the Drugs Controller General of India, the regulatory authority for pharmaceuticals and medical devices in India. CDSCO Online stands for Central Drugs Standard Control Organization, which is the central drug regulatory authority in India responsible for approving drugs for marketing in the country.

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Manufacturers or authorized agents of medical devices are required to register their devices with the CDSCO registration and obtain clearance for the device's safety and efficacy before they can be sold in the Indian market. This process includes obtaining a Unique Device Identification (UDI) number for the device, and submitting documentation and test reports to the CDSCO.

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It's important to note that the specific eligibility criteria for CDSCO registration may vary depending on the type of product and the regulatory requirements at the time of application. It's recommended to consult with a qualified regulatory professional or CDSCO representative to ensure that you meet the latest eligibility criteria for CDSCO registration in India.