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Basics & Checklists for Medical Device Manufacturing license. Compiled by Rihim Pharma. The MD 5 Manufacturing License in CDSCO India refers to the license required for the manufacturing of medical devices under the Medical Device Rules, 2017. This license is issued by the Central Drugs Standard Control Organization (CDSCO), which is the national regulatory body responsible for regulating medical devices and drugs in India. The request for MD 5 license is made in MD 3 License for Class A and B devices; and MD 7 License for Class C and D devices. Your product should be rightly classified under MDR guidelines before applying for the MD 5. Consult with us for creating your regulatory strategy. Class A & B (Low-risk medical devices) are those that have a low potential to cause harm to patients and do not require extensive regulatory oversight. Examples of such devices include surgical gloves, stethoscopes, and thermometers. To obtain the MD 5 Manufacturing License, the manufacturer must comply with the regulatory requirements outlined in the Medical Device Rules, 2017. This includes providing the necessary documentation and paying the requisite fees. The application is then reviewed by CDSCO, and if all requirements are met, the license is granted. The MD 5 Manufacturing License is essential for manufacturers of low-risk medical devices in India as it ensures that the devices meet the safety and quality standards set by CDSCO. It also helps to ensure that the manufacturing process is conducted in a controlled and regulated environment, which can help to prevent the production of sub-standard or counterfeit medical devices. Overall, the MD 5 Manufacturing License plays a critical role in ensuring the safety and efficacy of low-risk medical devices in India. Official Checklist of documents: Class A & B (MD 3 Application Checklist): Download PDF Class C & D (MD 7 Application Checklist): Download PDF Want to get MD5 license for your plant? Connect with us.

Basics & Checklists for Medical Device Import application. Compiled by Rihim Pharma. After the release of Medical Device Rules 2017, a whole new array of terminologies have evolved in the medical device industry. One of the most frequently asked question is "what to do if I'm an importer of medical devices in India?" The straight answer is - apply for the MD14 licence at CDSCO. Here are a few insights on the same. The MD 14 Import license in CDSCO India refers to the license required for the import of medical devices that are classified as medium and high-risk under the Medical Device Rules, 2017. This license is issued by the Central Drugs Standard Control Organization (CDSCO), which is the national regulatory body responsible for regulating medical devices and drugs in India. To obtain the MD 14 Import license, the importer must comply with the regulatory requirements outlined in the Medical Device Rules, 2017. This includes providing the necessary documentation and paying the requisite fees. The application is then reviewed by CDSCO, and if all requirements are met, the license is granted. The MD 14 Import license is essential for the import of medical devices into India as it ensures that the devices meet the safety and quality standards set by CDSCO. It also helps to prevent the import of sub-standard or counterfeit medical devices, which can be dangerous for patients. Overall, the MD 14 Import license plays a critical role in ensuring the safety and efficacy of medical devices in India. MD 14 Application Documents required from the Exporter or Manufacturer MD 14 Application Documents required from the Importer or Indian Agent For more information, connect with us.

The medical device industry is one of the fastest growing and most important industries in health care that brings innovation and new technologies. The med-tech sectors make huge investments to make good quality and innovative medical devices to provide the best possible treatment to patients. Licensing is a vital procedure for any medical device manufacturing company to ensure that the device is free from vulnerabilities or harmful effects. Medical device licensing in India is done by Central Drugs Standard Control Organization (CDSCO). The devices are granted licenses based on their categories. Applications for Manufacturing Licence in India The companies that manufacture Class A or Class B medical devices have to go through a procedure by applying for a license to sell or distribute medical devices. These manufacturers have to apply to the State Licensing Authority for approval from the Ministry of Health and Family Welfare's online portal, depending on the applicant's location. In India, form MD-3 and Form MD-5 are required to obtain permission to manufacture Class A-B medical devices. Apart from these forms differ based upon the intended purpose of application.  Form MD-26 is the manufacturing license of innovative or new medical devices being registered for the first time in India. Central Drugs Standard Control Organization (CDSCO) is the regulatory authority of India that grants permission to manufacture/import new medical devices in India. What is MD-3, MD-5 & MD-26? MD-3 is the application form. By this application form, an MD-5 license is given to manufacturers for a license to manufacture and sell Class A or Class B Medical Devices. Form MD-26 is the application form through which manufacturers can get permission from CLA either for manufacturing/importing medical devices that do not have predicate devices in India The next steps After the collection of the required documents, below are the steps that are to be followed: Inspection of Application It is one of the most important steps of the process as if any shortcoming/discrepancy is noted, a query shall be raised. The application moves forward when the reply to the query is received from the applicant. Audit of applicant premises After the successful scrutinizing of the application, an audit report and the notification of closure of the applicant’s premises are prepared by the Central Drugs Standard Control Organization (CDSCO). After the audit report is submitted, it is reviewed and if found acceptable, it is moved forward for further process. Scrutiny of the products The products for which the application is applied are then evaluated. If they are found in accordance with the norms, the application will be considered for grant of a license The permit of license The license is granted with the validity of 5 years on the attainment of all the laid down prerequisites How Rihim Pharma can help? Rihim Pharma has a team of experts that can help in the pre-screening of all the documents that are needed to make sure that they are free from any errors or need any updates necessary according to India’s updated norms or recent changes. Although manufacturers can collect all the documents to be submitted but knowing the correct way of presenting information is also a necessity. We can help you in the pre-screening of the application before its submission so that it is free from any disparity and can help you to reply back in case any queries are raised on the application and resolve any non-compliances with the application. Any individual or company involved in the manufacturing of medical devices needs to obtain a manufacturing license for medical devices. Sometimes, this can be a tedious process for them. Rihim Pharma has a technical team that helps manufacturers to study their products to create the best possible route, making the approval process easier for the manufacturers. We have a redesigned checklist and processes that have simplified the registration formalities for the clients to make the process smooth which ultimately speeds up the timeline for getting the approvals. To know more, connect with our team at info@rihimpharma.com

New Drug is any molecule or Fixed Dosed Combination (FDC) which is registered for the first time in India. The registered drug is referred to as a “New Drug” for 4 years after the date of first approval. The first application requires a clinical trial, whereas the subsequent applications can just go with the Bioequivalence (BE) studies which are much cheaper and faster. Who regulate drugs approval in India? In India, Indian Parliament proclaimed The New Clinical Trial Rules & Amendment 2022 in order to regulate the import, manufacturing, distribution, and sales of new drugs. CDSCO is India’s drugs regulatory body for pharmaceuticals, medical devices, and cosmetics was established along with its licensing authority, the Drug Controller General of India (DCGI). How Do New Drugs Impact Business? New Drugs helps to create a portfolio of uncommon, new, and trending products. Big pharma and marketing partners often look for the manufacturers with new drug or products The DCGI publishes a list highlighting companies that have received New Drug Approvals, which can benefit the branding of the company With the new drugs the company can standout and it will help in extra edge over other companies. There are not many companies that have the resources for filing New Drug Application. How Regulatory Specialists help in Regulatory Filings? Regulatory affairs play an important role in the pharmaceutical industry to oversee the sanctity of the procedure and the formulation of a drug. In terms of regulatory filings, the procedure of the drug passing through regulation from the date of filing till approval is a hectic and elongated procedure. Applying a new drug for approval demands a variety of different documentation. Primarily, there are two reasons behind the failure of drug applications, one of them being unsatisfactory information provided to the regulatory body and the other being inadequate drug performance. Thereby refining and executing the regulatory strategies in an organized manner becomes necessary to achieve a positive resolution. To guide companies or organizations through these procedures is where a regulatory specialist turns out to be useful. A regulatory consulting specialist works by helping a company or organization meet the necessary regulations that are required for its products. The following are some of the tasks and responsibilities of regulatory specialists: Providing a deep understanding of new and existing regulations impacting the organization’s products and procedures Establishing clearly documented protocols Explaining regulations, procedures, and policies to the employees and stakeholders as necessary Reviewing marketing, legal, and technical documentation to assess compliance Regularly reporting on compliance status and measures to both internal and external parties Acting as a link between the organization and the state, local, federal, or international agencies in order to submit the required forms and paperwork in a simplified manner How can Rihim Pharma help you? Developing a new drug not only takes a lot of resources but a great amount of effort added to it and thereby taking a drug to its end goal, the consumers, demands a lot of effort and patience. Any new drug in India must follow a specific procedure and submit several documents in order to be approved by the CDSCO. We at Rihim Pharma will help guide you through each stage of this procedure. Rihim Pharma is determined to provide a simpler and hassle-free experience to our clients. Here is a glimpse of some of the services you will receive from our end: New Drug suggestions based on existing portfolio and manufacturing capabilities Managing end-to-end regulatory affairs from the compilation of the documents to submission and approval Help in sub-contracting CT/BE/Toxicity studies and with our great experience in SEC, we can help you prepare for the SEC GAP analysis of documents to reduce queries in NDA Creating a regulatory strategy that gives your business an edge Rihim is doing this for over 500+ Pharma Companies, see our clientele