#form 42 cdsco

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The Central Drugs Standard Control Organization CDSCO license is the regulatory authority in India for pharmaceuticals and medical devices. Any person or entity involved in the manufacture, distribution, import, or sale of drugs or import license for medical devices in India must obtain a license from CDSCO.

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Understanding the Latest Requirements: Form 42 and Form 43 for the Import Cosmetics in India

In the dynamic landscape of global trade, the Indian cosmetics market stands out as a lucrative opportunity for businesses seeking expansion. However, entering this market requires careful navigation of regulatory requirements, particularly in terms of form submission. Two critical documents, Form 42 and Form 43, play a pivotal role in facilitating the importation of cosmetics into India. In this article, we'll delve into the latest requirements surrounding these forms and their significance for importers.

The Importance of Form 42 and Form 43

Form 42 and Form 43 for the import of cosmetics in India are mandated by the Drug Controller General of India (DCGI) under the provisions of the Drugs and Cosmetics Act, 1940, and the rules framed thereunder. These forms serve as crucial instruments for ensuring the safety, quality, and compliance of imported cosmetics entering the Indian market.

Form 42: Import of Cosmetics

Form 42 is a document prescribed for the import of cosmetics into India. It is essentially an application form that importers need to submit to the DCGI for obtaining authorization prior to importing cosmetics. The form includes essential details such as the name and address of the importer, details of the manufacturer, product information, and compliance declarations.

Form 43: Test License for Import of Cosmetics

Form 43, on the other hand, pertains to the issuance of a test license for the import of cosmetics. Importers are required to submit this form along with the requisite fees to the DCGI for obtaining a test license. The test license allows importers to import a small quantity of cosmetics for testing and analysis purposes before commercial distribution.

Latest Requirements and Updates

In recent years, the Indian regulatory landscape governing cosmetics importation has witnessed notable updates and amendments. Importers must stay abreast of these changes to ensure compliance with the latest requirements. Key considerations include:

Product Registration: Certain categories of cosmetics may require product registration with the Central Drugs Standard Control Organization (CDSCO) before importation. Importers must verify whether their products fall under the purview of mandatory registration.

Labeling and Packaging Requirements: Compliance with labeling and packaging regulations is paramount. Cosmetics intended for importation into India must adhere to specific labeling requirements, including the declaration of ingredients, usage instructions, and safety warnings in the prescribed format.

Good Manufacturing Practices (GMP): Importers are expected to source cosmetics from manufacturers adhering to Good Manufacturing Practices (GMP) to ensure product quality and safety.

Conclusion

In conclusion, navigating the regulatory framework for importing cosmetics into India requires a thorough understanding of the latest requirements, including Form 42 and Form 43. Importers must diligently comply with these requirements to facilitate smooth and legally compliant importation processes. By staying informed and proactive, businesses can seize the vast opportunities offered by the thriving Indian cosmetics market while upholding the highest standards of quality and safety.

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CDSCO Import License for Medical Devices

Medical Device Import License:

Applicable when we have to import medical devices from other countries to India. However they need to be classified according to CDSCO notified devices list. CDSCO has complete procedure for granting license for medical device imported in the countries.

Application for grant of import license

An authorized agent (who must have wholesale license for local distribution) having license to manufacture for sale or distribution or wholesale license for sale or distribution under these rules, shall make an application for grant of import license for medical device to the Central Licensing Authority through an identified online portal of the Ministry of Health and Family Welfare in the Central Government in Form MD-14 for obtaining a license.

Where the Central Licensing Authority, has reason to believe that the quality of the medical device is compromised, and decides to subject to its evaluation, tests or evaluation, test or examination, to the testing laboratory as specified by the Central Licensing Authority.

After examining the documents along with the application on the basis of the inspection report, if the inspection has been done by the Central Licensing Authority can be satisfied, grant license in Form MD-15 may reject this application for this reasons shall be recorded in writing within the time of nine months from the date of the application.

In the process of rejection the applicant can make an appeal to the Central Government within the time of forty five days and that the Government, may after the enquiry in this matter pass order in relation there within the time of ninety days from the date of appeal.

Operon Strategist assists pharma or medical device distributors and medical device wholesalers in India to procure CDSCO import license. An Import license is issued for import of medical device from other country to India. Both the foreign company and Indian company jointly needs to submit the documentation for medical device and manufacturing unit.

Medical Devices: - A medical device is a device or a equipment used for medical purposes. A medical device helps patients by health care providers, to diagnose and treat patients and help them overcome their sickness or disease. Important potential for dangers are basic when using a medical device for purposes and hence medical device must be proved safe and effectual with reasonable assurance before regulating government allows marketing of the device in country. Medical devices differ in both their purposeful use and indications for use. For example range from simple new risk devices such as Thermometer, medical gloves, bedpans to complex high risk devices which are implanted and support life.

Medical Device Registration: - Medical Devices entering India must be in compliance with the Indian Medical Device Regulation set forth by the CDSCO. The CDSCO is responsible for the approval and regulation of New Drugs and Clinical Trials in the Country, laying down the standards for Drugs, control over the quality of imported drugs, co-ordination of the activity of State Drug Control Organizations.

The Government of India has issued a Gazette Notification G.S.R 426(E) dated 19th may 2010 for amending the Drugs and Cosmetics Rules, 1945 providing for registration of import of cosmetics into the country. The above provision was to come into effect from 1st April, 2011. But in the view of the various possible difficulties apprehended by the stakeholders, its implementation has been deferred till the 31st March, 2013.

CDSCO Overview and History:-

Central Drugs Standard Control Organization is the main regulatory body for medical device in India is Central Drugs Standard Control Organization (CDSCO). The Application for all classes of medical devices is submitted to Central Licensing Authority, where the (DCGI) Drug Controller General of India takes the responsibility for approval of Manufacturing, Registration, Import and Sale of Medical Devices in India.

Authority of CDSCO

Below functions are undertaked for CDSCO for Medical Device and Cosmetics

Import of all Classes of medical devices

Manufacture all Classes of medical devices

Clinical investigation and approval of investigating medical devices

Clinical performance evaluation and approval of new in vitro diagnostic medical devices

Co-ordination with the state licensing authority

Manufacture for sale or distribution of Class A or Class B medical devices

Sale, Stock, exhibit, or offer of sale or distribution of medical devices of all classes.

The central licensing authority, may with the prior approval of the central government by an order in writing, delegate all or any of its powers to any other officer of the Central Drugs Standard Control Organization.

The Central Government may, by notification designate such institute firm or a Government aided or Government organization which fulfills the criteria specified from time to time by the government as the National Accreditation Body. Provided that the National Accreditation Board for certification Bodies under the Quality Council of India, registered under the Societies Registration Act, 1860 (21 of 1860) set up by the ministry of commerce and industry in the Government of India shall act as the National Accreditation Body for the purposes of accrediting Notified Bodies referred to in rule 13, till such time any other body for the purposes is notified, with immediate effect.

Notified Body working with State FDAs

The Notified Body is competent to carry out the audit of manufacturing sites of Class A and Class B medical devices to verify conformance with the Quality Management System and other applicable standards as specified under these rules in respect of such medical devices as and when so advised by the State Licensing Authority and Central Licensing Authority.

Medical Device manufacturing License

Test license

The test license is the 1st step for the manufacturing license which is mandatory. Form no 11 or Test license is granted for importing small quantities of drugs or medical devices, which is otherwise banned under the section 10 of the Drugs and Cosmetics Acts and Rules, 1945 in the purpose of analysis, testing and examination. Basic details of medical devices are required in this table;

Validity of license

A License granted under sub-rule (1) of rule 36 shall remain valid in perpetuity, unless it has been cancelled or surrendered, provided by the authorized agent deposits the license retention fee with the Central Licensing Authority as specified in the second schedule for each overseas manufacturing site and for each licensed medical device after completion of every five years from the date of its issue: Provided that the Central Licensing Authority may permit to deposit the license retention fee after due date but before expiry of ninety days with a late fee calculated at the rate of two per cent. per mensem Provided further that if the licensee fails to deposit the license retention fee within the above stipulated period, the license shall be deemed to have been cancelled.

Application for manufacture for sale or for distribution of Class A or Class B medical device.

Any person who intends to manufacture a Class A or Class B medical device including in vitro diagnostics medical device shall make an application for grant of license or loan license to manufacturer for sale or for distribution to the State licensing Authority.

The applicant under sub-rule (1) shall be made through an identified online portal of the Ministry of Health and Family Welfare in the Central Government in Form MD-3 for License or in Form MD-4 for loan license accompanied with a fee, as specified in Part II of the fourth schedule.

Class A and B application is done under the CDSCO portal.

The required audit for such manufacturing site is required by the registered Notified Body.

Application for manufacturing Class C and Class D medical devices

An application shall be made to the Central Licensing Authority through an identified online portal of the Central Government for License to manufacture for sale and distribution.

The Central Licensing Authority may, where required, avail the services of a Notified Body referred to in sub-rule (4) of rule 13 for inspecting the manufacturing site of Class C and Class D medical devices.

Manufacturing License Application

Documents Requirements

ISO 13485 certificate

Site master file

Device master file

Test license

Cosmetic Import License

Manufacturing License Application

Although the law does not require cosmetics products and ingredients except for the color and additives, which has to be approved by the FDA before they go into the market. No cosmetics shall be imported into India unless the product is registered under the rules by the licensing authority appointed by the Central Government under rule 21 or by any person to whom such powers may be delegated under rule 22.

Form and manner of application for registration certificate:

An application for issue of a Registration Certificate for cosmetics intended to be imported into India shall be done in the Form No-42 either by the manufacturer himself or by his authorized agent or the importer in India or by the subsidiary in India, authorized by the manufacturer and shall be accompanied by a fee of two hundred and fifty US Dollars or its equivalent to the Indian rupees for each brand of cosmetic.

Grant of registration certificate

On receipt of an application for Registration Certificate in the form and manner specified in rule 129A, the licensing authority shall, if satisfied, issued a Registration Certification in form 43 subject to the conditions of the registration certificates in form 43

If the application is completed in all respects and information mentioned in the schedule, the licensing authority shall, within six months from the date of receipt of an application, issue such Registration Certification and in such exceptional situations and for no reasons to be recorded in the writing the Registration Certificate may be issued within such extended period, not exceeding for three months as the licensing authority may deem fit.

The Duration of Registration Certificate

The duration for the Registration of certificate, unless sooner suspended or cancelled, shall be valid for a period of Three years from the date of its issue.

Operon strategist’s expertise

Operon strategist is the leading medical device regulatory consulting company; we provide regulatory guidance to various manufacturers in the healthcare industry to ensure the strategic development of these manufacturers. We serve our clients by providing turnkey services, system implementation, training, licensing, regulatory approvals and certifications.

Competencies

We reduce our client’s costs and efforts.

We have Strong personal relations with regulated bodies.

We also have Strong and experienced regulatory team.

We represent on behalf of our client’s for Audits of FDA, ISO, & CE.

Competent Technical staff.

Case Study

Avoiding market access delay due to incorrect product classification

A start-up company (with the help of two innovative physicians) developed a tool that provides a safer, more effective way to alleviate a common orthopedic condition. Although early funding came at a cadence that kept progress moving steadily ahead, rounds for managing the entire life cycle to reach commercial distribution were relatively small. But by correctly classifying the device, time to market was minimized.

The Client’s Challenge

The company had no staff that was acquainted with FDA regulations regarding medical device submissions. It initially assumed that, because of the invasive nature of the product, it had to be a Class II device and would therefore require a 510(k).

Operon Strategist’s Approach

Our company Operon Strategist took the time to integrate into the client’s team in order to identify both the technology and business goals. Starting with the critical questions “why” and “how”, Operon also identified a new strategic approach. First, a Class I predicate was identified and a regulatory strategy was developed. Then, a pre-submission package was prepared to allay regulatory strategy concerns from the board of directors and to demonstrate the feasibility of the concept. After a successful FDA interaction, Operon’s consultants further helped manage an iterative and interactive pathway to complete the design process and design validation. The final step was to design a CFR820 compliant quality system addressing the unique needs of supplier management and complaint handling in a virtual company. This approach kept the overhead burden down while at the same time providing a solid launch pad for future growth.

The Outcome

The client was able to enter market faster and with less expense by using a regulatory strategy and data supporting registration and then listing as a Class I device. While typical concept-to-bedside timelines for devices can vary anywhere from 18 month to 8 years, by carefully examining the requirements for Class I devices, the Company was able to gain FDA agreement that the device was a Class I, requiring only general controls. This strategy shaved years off the development pathway and successfully avoided many pre-clinical and clinical costs. From concept to market the product was in the hands of physicians within two and a half years.  At the same time, the company’s quality control system and selection of vendors has assured full compliance with FDA design controls and all regulatory responsibilities.

Read More - CDSCO Import

License

Contact details –Phone no -  9325283428Mail  -

dm@operonstrategist.com

If  You Want Medical Devices Services Consultation For Following.

   1.    

Medical Device Manufacturing

   2.    

CDSCO Registration

   3.    

FDA 510 k clearance

   4.    

Continuous Improvement Program

   5.    

Design Control Requirements

   6.    

QMS Certification Services

   7.    

Manufacturing Plant Layout Design

   8.    

Primary Packaging Consultant

   9.    

CE Marking Consultant

 10.

Combination Product

11.

Medical Device Design And Development

 12.

Clean Room Design Consultant

13.

ISO 13485 Certification

14.

ISO 15378 certification

15.

Medical Device Process Validation

16.

21 cfr part 820

17.

21 cfr part 210 and 211

18.

DMF submission

19.

CAPA Management

20.

TURNKEY PROJECT CONSULTANT

21.

Manufacturing Site Conceptualization

[godollyfan]

Cosmetic Registration in India

The brand name proprietor, who has no manufacturing unit in India intends to sell his goods by the method of import through their appointed shippers/merchants/advertisers in India, is currently needed to obtain a registration authentication to continue with their marketing exercises in India. An application for registration on Form-42, alongside all essential documents is required to be submitted to Drugs Controller General (I), CDSCO, FDA office in New Delhi.

[corpseedgroup]

CDSCO stands for Central Drugs Standard Control Organization. It is the national regulatory authority for pharmaceuticals and medical devices in India. CDSCO 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.

[corpseedgroup]

The Central Drugs Standard Control Organization (CDSCO) is the national regulatory authority in India responsible for the regulation of pharmaceuticals, medical devices, and cosmetics. Registration with CDSCO is mandatory for manufacturers, importers, and distributors of pharmaceuticals and medical devices in India.

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The approval process can take several months to several years, depending on the complexity of the CDSCO new drug approval and the amount of data required for evaluation. CDSCO also has a priority review process for drugs that address an unmet medical need or have significant therapeutic benefits, which can expedite the approval process.

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Getting a manufacturing license for medical devices in India requires following certain procedures and fulfilling specific requirements. It is important to note that the process for obtaining a manufacturing license for medical devices in India can be complex and time-consuming. It is recommended that you seek the help of a regulatory consultant or lawyer who has experience in this area to guide you through the process.

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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:

[corpseedgroup]

The Central Drugs Standard Control Organisation (CDSCO) is the national regulatory body for pharmaceuticals and medical devices in India. The CDSCO is responsible for regulating the import, manufacture, distribution, and sale of drugs and medical devices in India to ensure their safety, efficacy, and quality. Overall, the CDSCO plays a critical role in ensuring that drugs and medical devices in India are safe and of high quality, which helps to protect the health of the Indian population.

[corpseedgroup]

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 certificate 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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DCGI stands for Drugs Controller General of India and CDSCO stands for Central Drugs Standard Control Organization. DCGI is a regulatory body responsible for approving and monitoring the manufacture, distribution, and sale of drugs and medical devices in India, while CDSCO is a division of DCGI and is responsible for the pre-market clearance and post-market surveillance of drugs and medical devices in India.

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Manufacturers or authorized agents of medical devices are required to register their devices with the CDSCO 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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The CDSCO will assess your facility's compliance with Indian Good Manufacturing Practices (GMP) and other regulations, and if everything is found to be in order, a certificate will be issued. It's best to check the website of CDSCO for the most up-to-date information on the application process and requirements. An Import Registration Certificate (IRC) is a document issued by the Central Drugs Standard Control Organization (CDSCO Kolkata) in India that allows a company to import drugs and pharmaceuticals into the country.

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The Central Drugs Standard Control Organization (CDSCO Online) is the national regulatory body for pharmaceuticals and medical devices in India. Its primary role is to ensure that all drugs and medical devices available in the country are safe, effective, and of good quality.

[corpseedgroup]

The Drugs Controller General of India (DCGI) is the regulatory body responsible for approving and overseeing the manufacturing of drugs in India. DCGI functions under the Central Drugs Standard Control Organization CDSCO Kolkata, which is the national regulatory agency for pharmaceuticals and medical devices. The DCGI is responsible for granting licenses to manufacturers and importers of drugs and for ensuring that these manufacturers comply with the relevant laws and regulations. This includes enforcin