#cdsco import license.

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CDSCO Certification & Registration | Import License & Process | Central Drugs Standard Control Organisation : Eikomp

CDSCO, Central Drugs Standard Control Organisation, CDSCO Certification, CDSCO Registration, CDSCO Certificate, cdsco license,cdsco registration process, cdsco import license.

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CDSCO Registration: Ensuring Quality in Healthcare Trade

Understand the importance of CDSCO registration for drugs, medical devices, and cosmetics. Enhance your business with global compliance and quality assurance.

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A major update in 2024 is the revised drug registration process. Now, CDSCO requires a more extensive review of safety data, especially for new or innovative drugs. This means companies have to provide comprehensive safety reports along with their applications, including detailed clinical data from other countries if the drug is being used internationally.

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Unveiling the Future of India’s Medical Devices Market: Opportunities and Challenges

In the past decade, the medical devices market in India has witnessed a remarkable surge, driven by growing demand for various medical devices, including consumables, dental products, diagnostic imaging equipment, prosthetics, orthopedics, patient aids, and more. To support and regulate this booming sector, the government has enacted several policies and reforms. These initiatives aim to foster the development of new technologies, ensure healthcare safety and quality, and meet the diverse needs of India’s health system.

However, despite these advancements, a significant gap remains between the demand for medical devices in India and their availability. To address this, the government has made notable changes to the Foreign Direct Investment (FDI) policy, encouraging the importation of medical devices to bridge the supply gap.

In this blog, we will explore the medical devices market in India and discuss how foreign medical device companies can successfully enter the Indian marketplace.

Market Volume of Medical Devices in India

India stands as the fourth-largest market for medical devices in Asia, behind Japan, China, and South Korea, and is among the top 20 global markets for medical devices. Let’s dive into the numbers that illustrate the size of India’s medical devices sector:

- In 2022, the medical devices market in India was valued at approximately Rs. 90,000 million (about US$11 billion). The market is projected to grow to US$50 billion by 2030, with a compound annual growth rate (CAGR) of 16.4%.

- The diagnostic equipment segment is expected to reach US$6 billion by 2027, with a CAGR of 16.4% from 2020 to 2030.

- India’s reliance on imported medical devices grew by 21% between November 2022 and October 2023, with imports totaling Rs. 61,262.84 crore (US$7.23 billion).

Key Drivers of Growth in the Medical Devices Market in India

Several factors contribute to the rapid growth of the medical devices market in India. These include:

- Growing Population: With a population of over 1.4 billion, there is rising demand for medical devices to address chronic diseases, advanced diagnostics, and treatment options.

- Aging Demographics: By 2030, India’s elderly population is expected to reach 194 million, driving demand for medical devices that cater to mobility, diagnostics, and chronic disease management.

- Increase in Chronic Diseases: According to the International Diabetes Federation, India’s diabetes prevalence is predicted to reach 74% by 2025. Alongside this, the rise of other chronic conditions such as cancer and cardiovascular diseases further fuels the need for advanced diagnostic and therapeutic devices.

- Expansion of Health Insurance Coverage: Government initiatives like Ayushman Bharat, which provides health benefits to 500 million citizens, have significantly increased the need for medical devices in India.

- Rising Middle Class and Health Awareness: By 2026, 8% of Indians are expected to earn over USD 12,000 annually, and 73 million households will join the middle class within the next decade. This economic growth and awareness are driving healthcare spending and the adoption of health technologies.

- Growth of Private Healthcare: India’s private healthcare sector has seen rapid expansion, with 393 hospitals accredited by the National Accreditation Board for Hospitals & Healthcare Providers (NABH) by 2019, increasing demand for high-quality medical devices.

- Medical Tourism: India is becoming a major hub for medical tourism, attracting nearly 2 million international patients annually and generating US$6 billion in revenue, projected to reach US$13 billion by 2026. The medical devices market in India is a crucial enabler of this growth, supported by the government’s “Heal in India” initiative.

- Favorable Regulatory Environment: Regulatory reforms, such as the Medical Devices Rules, 2017, have streamlined access to the Indian market, supporting both domestic manufacturers and importers.

How Foreign Medical Device Companies Can Access the Indian Market

Foreign companies looking to enter the medical devices market in India should follow these steps:

1. Market Research: Conduct thorough research on market demand, pricing, competition, and regulatory requirements to identify export opportunities.

2. Regulatory Compliance: Familiarize yourself with India’s regulatory landscape, especially the Central Drugs Standard Control Organization (CDSCO), which governs medical device registration and approval.

3. Leverage Government Initiatives: Take advantage of tax benefits, regulatory harmonization efforts, and policies promoting high-quality medical devices in India.

4. Quality Assurance: Ensure compliance with the Bureau of Indian Standards (BIS), ISO, and IEC guidelines to build trust among Indian consumers.

5. Regulatory Support: Partner with regulatory consultants specializing in the medical devices market in India to navigate the approval process and ensure successful entry.

Future Outlook

With continued government support and technological advancements, the medical devices market in India is poised for robust growth. The government’s focus on regulatory ease, fostering innovation, and creating a favorable manufacturing environment will facilitate greater market access for foreign manufacturers, helping them capitalize on India’s rapidly expanding healthcare sector.

At Regulatory Solutions India (RSI), we specialize in regulatory consulting for medical devices, IVDs, cosmetics, and more. Let us help you navigate the medical devices market in India and achieve success. Send us an email here to discuss your specific needs and we’ll move forward from there.

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Innovations in Cosmetic Manufacturing: What’s Changing in 2024?

The cosmetic industry is continuously evolving. As consumer preferences shift and new technologies emerge, cosmetic manufacturing must also adapt to meet the growing demand for innovative, safe, and sustainable beauty products. In 2024, the cosmetic manufacturing sector is witnessing groundbreaking changes driven by advancements in technology, sustainability practices, and changing consumer trends. Visit - https://guest-post.org/innovations-in-cosmetic-manufacturing-whats-changing-in-2024/

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CDSCO Registration Online in India

CDSCO Registration is a compulsory requirement for any entity seeking to manufacture, distribute, or import pharmaceuticals and cosmetics. This regulatory approval ensures compliance with safety and quality standards, granting a license to operate in the Indian market the process involves submitting detailed applications, complying with firm guidelines, and undergoing regulatory inspection. 

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Simplify Cosmetic Registration in India with FDApal

Simplify the intricate process of cosmetic registration in India with FDApal. Our intuitive platform provides step-by-step guidance, ensuring compliance with regulations. Trust FDApal to streamline your registration journey, saving time and resources while navigating the complexities of the Indian market seamlessly.

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Are you looking for medical device registration in India the apply now. Comment below and we will connect with you on the platform. Or you can make a call

Call Us On - +91 9899-998-002

Mail Us - hello@medicaldeviceregistration.com

Website - https://medicaldeviceregistration.com/

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CDSCO Import License for Medical Devices

The Central Drugs Standard Control Organization (CDSCO) is the national regulatory body for pharmaceuticals and medical devices in India. The CDSCO is responsible for the registration, licensing, and regulation of medical devices in India.

To import medical devices into India, a valid CDSCO import license is required. The import license is issued by the CDSCO after the device has been registered with the organization. The registration process involves submitting an application along with relevant documents, such as product information, manufacturing details, and clinical trial data, to the CDSCO.

Once the registration process is complete, the CDSCO will review the application and issue an import license if the device meets the required standards and regulations. The import license will include details such as the name and address of the importer, the name and model of the device, and the quantity and value of the device.

It is important to note that certain medical devices may require additional approvals or certifications from other regulatory bodies in India, such as the Bureau of Indian Standards (BIS) or the Indian Council of Medical Research (ICMR) before they can be imported and sold in the country.

In summary, obtaining a CDSCO import license for medical devices in India involves registering the device with the CDSCO and ensuring that it meets the required standards and regulations. The CDSCO import license is a crucial requirement for importing medical devices into India, and importers must comply with all relevant regulations and requirements to ensure the safety and effectiveness of the device.

[corpseedgroup]

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.

[medwisdom]

How To Apply Manufacturing License For Medical Device In India?

If you are manufacturer or distributor, looking for manufacturing license for your Medical Device, this guide will help you to simply understand the documents and procedure of obtaining manufacturing license for medical device in India. Manufacturing license is issued by the licensing authority of India. Classification of medical device determines which licensing authority responsible for issuing manufacturing license. State licensing authority is responsible for grant of manufacturing license for class A and B medical device. Central licensing authority is responsible for issuing manufacturing license for class C and D medical device based on the risk it possesses. This guide will help you to figure out your queries for obtaining manufacturing license for medical device in India.

Who Can Apply For Manufacturing License For Medical Device?

Below are some individual who can apply for manufacturing license for medical device in India:

Manufacturer: who is responsible for production and manufacturing of medical device can apply for manufacturing license.

Importer: Person who is looking to Import medical device in India can apply for manufacturing license.

Distributor or Authorized Person: Person who is authorized from manufacturer can apply for license.

What Is Medical Device? How Many Classes Of Medical Device Are there?

Medical device is any instrument, equipment, implant, or machine that is used in diagnosis, treatment, and mitigation of disease in humans. Medical device are classified into four types based on the risk it possesses:

Class A: Low risk medical device (stethoscope and bandages)

Class B: Intermediate risk (syringe and glucose meter)

 Class C: Moderate high risk ( catheter and implants)

Class D: Very high risk (heart valves)

Documents Required For Obtaining Manufacturing License For Medical Device In India

For the grant of manufacturing license for your medical device, following are some key documents required as per CDSCO guidelines:

Application Form: Form MD-3 is filled for class A and B medical device, form MD-7 for class C and D medical devices.

Plant Master File: Plant master file having information about the manufacturing site, layout of facility, and equipment used.

Device Master File: Detail description of medical device and risk possibilities along with the specifications and design.

Quality Management System: QMS certificate issued under ISO 13485 certification demonstrating high performance quality standard of medical device in compliance with regulatory framework.

Technical Documents: Most important documents including product specifications, clinical report and risk management plan of medical device.

Stability Data: Stability data demonstrating the shelf life of medical device.

Deceleration or Understanding: Understanding from manufacturer, ensuring compliance of medical device with regulatory standards.

Labelling and Packaging: Details of labelling for medical device is required as per Medical Device Rules, 2017.

Procedure To Obtain Manufacturing License For Medical Device

Following are the main steps for the grant of manufacturing license:

Visit Sugam Portal: Register on the CDSCO/sugam portal by creating an account.

Application Submission: Select the Form applicable as per your medical device registration. Fill the form details carefully and submit on the portal.

Fee Payment: Pay the applicable money as per the Medical Device Rules, 2017.

Audit Inspection: Specific regulatory authority will conduct the inspection of product manufacturing site, to ensure the compliance of medical device as per the regulatory standards.

License Issuance: After the successful evaluation of manufacturing site along with your application form documents, Licensing authority will grant the manufacturing license.

How Medwisdom Lifescience Can Assist You With Obtaining Manufacturing License?

Medwisdom offers expert assistance in medical device registration and license, we have secured over 2500 medical device registration so far, we take pride in our exclusive achievement for grant of 500 plus manufacturing license across all classes of medical device (A to D). Our expertise ensure timely registration and cost effective solutions for obtaining manufacturing license.

FAQS

Who Needs Manufacturing License For Medical Device In India?

Any company or individual planning to manufacture medical device for the purpose of sell or marketing, must obtain the manufacturing license for medical device under the Medical Device Rules, 2017.

Who Issue Manufacturing License For Medical Device?

State Licensing Authority is responsible for issuing manufacturing license for class A and class B medical device. Central Licensing Authority

What Is The Validity of Manufacturing License For Medical Device?

Validity of manufacturing license is five years from the date of issue.

What Is The Timeline For Obtaining Manufacturing License?

The approximate time for obtaining manufacturing license for medical device takes 5-6 months, based on the completeness of your application and the response from the regulatory authority.

[regulatorysolutionsindia]

Regulatory Processes for Intraocular Lenses (IOLs) in India

 Intraocular Lenses (IOLs) are essential medical devices used in surgeries to replace the eye's natural lens, particularly for cataracts and vision correction.

What Are Intraocular Lenses (IOLs)?

IOLs are artificial lenses crafted from materials like plastic, silicone, or acrylic, designed to focus light onto the retina and implanted within the eye.

Types of Intraocular Lenses:

Monofocal IOLs: Provide single-focus distance vision.

Multifocal IOLs: Offer multiple focal points for different distances.

Toric IOLs: Correct astigmatism.

Accommodative IOLs: Adjust the shape to offer a natural vision range.

Extended Depth of Focus (EDOF) IOLs: Provide a continuous vision range with an elongated focal point.

Uses of Intraocular Lenses:

Cataract Surgery: Replace the cloudy natural lens.

Refractive Lens Exchange (RLE): Correct various vision problems such as near-sightedness, far-sightedness, and presbyopia.

Phakic Intraocular Lens (PIOL): Implant without removing the natural lens for significant correction.

Regulatory Approval for IOLs in India:

The Central Drugs Standard Control Organization (CDSCO) regulates IOLs, which are classified as moderate-to-high risk (Category C).

Regulatory Pathway:

CDSCO Registration: Involves submitting clinical data, technical details, and manufacturing information.

Licensing: Required for both manufacturers and importers.

Clinical Evaluation: Trials may be necessary to ensure safety and effectiveness.

Quality Management Systems: Compliance with standards like ISO 13485 is essential.

How RSI Helps in the Regulatory Process:

Regulatory Solutions India (RSI) assists with:

Preparing and submitting regulatory documents

CDSCO Registration/Licensing

Renewal/retention applications

Post-market surveillance and compliance 

Conclusion

Navigating the regulatory approval process for intraocular lenses (IOLs) in India involves adherence to rigorous standards overseen by the Central Drugs Standard Control Organization (CDSCO). From initial CDSCO registration to ongoing compliance and post-market surveillance, Regulatory Solutions India (RSI) provides crucial support to manufacturers and importers. By leveraging RSI's expertise in preparing regulatory documents, navigating licensing requirements, and ensuring adherence to quality management systems, companies can streamline the approval process and bring innovative IOLs to Indian patients effectively and efficiently. This partnership with RSI not only facilitates regulatory compliance but also contributes to improving access to advanced vision correction treatments across the country.

Regulatory Services India (RSI) is a leading regulatory consultancy in India that has extensive experience working with multinational companies as well as Indian pharmaceutical companies. Our team can assist you in developing an optimal regulatory strategy for your product and provide comprehensive guidance throughout the registration process. For more information, please visit our website.

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India Medical Device Registration - OMC Medical Limited

Regulatory Authority

Central Drugs Standard Control Organization

The Central Drugs Standard Control Organization (CDSCO) is the National Regulatory Authority (NRA) of India, responsible for regulating drugs and cosmetics under the Drugs & Cosmetics Act, 1940 and rules 1945.

It aims to ensure patient safety, rights, and well-being by ensuring the safety, efficacy, and quality of medical products manufactured, imported, and distributed in the country. CDSCO is responsible for drug approval, clinical trials, setting standards, controlling imported drug quality, and coordinating activities of State Drug Control Organizations.

It also grants licenses for specialized categories of critical drugs such as blood and blood products, I.V. fluids, vaccines, and sera, in collaboration with state regulators. The CDSCO strives for transparency, accountability, and uniformity in its services to ensure the safety, efficacy, and quality of medical products in India.

Link for Regulatory Authority

Local Regulation

Medical Device Act, 2017

Classification of Medical Devices

Class A, B, C and D

Listing or Registration Requirements

A voluntary registration pathway is available to medical devices from April 1, 2020, to October 1, 2021. Medical devices submitted under the new voluntary rules are referred to as “Non-Regulatory Medical Devices.” The registration process will generate a file number the same day which the importer must mention on the label of the medical device prior to placing the devices on the market.

After this voluntary period, all classes of products will need to either have an Import License or register through CDSCO’s online portal.

Class A and B non-Notified medical devices will have 12 months (i.e., by October 1, 2022) to obtain an Import License. Class C and D devices will have 24 months (i.e., by October 1, 2023) to meet the same requirement.

Registration for non-notified medical devices has become mandatory since October 2021.

Starting October 2022, class A & B non-notified devices will become notified devices and hence will require full product registration.

Starting October 2023, class C & D non-notified devices will become notified devices and hence will require full product registration

Documents Required for India Medical Device Registration

Form 40

TR6 Challan

Power of Attorney

Schedule D(I)

ISO 13485 Certificate

Full Quality Assurance Certificate

CE Design Certificate

Declaration of Certificate

Free Sale Certificate

Certificate of Marketability from GHTF countries

Regulatory Approvals

PMS Report

Plant Master File

Device Master File

Registration Timeline

6 to 9 Months

Registration Fee

Fee Details CDSCO

Application fees (online)

Class A: INR 500 (one site); INR 50 (each distinct device)

Class B: INR 1,000 (one site); INR 500 (each device)

Class C and D: INR 5,000 (one site); INR 1,000 (each device)

Application fees (hard copy)

Class A: INR 2,000 (one site); INR 500 (each device)

Class B: INR 5,000 (one site); INR 2,000 (each device)

Class C and D: INR 10,000 (one site); INR 5,000 (each device)

License Validity

Registration certificate (valid for 3 years): Generally, it’s recommended to apply for renewal 6 months before expiry. This ensures enough time for processing and avoids potential interruptions in business operations.

Import license (valid for 5 years): You need to submit the renewal application within 3 months of the expiry date.

Special Labelling Requirements

All the documents must be submitted in English

Additional Comments

Registration for non-notified medical devices has become mandatory since October 2021.

Starting October 2022, class A & B non-notified devices will become notified devices and hence will require full product registration.

Starting October 2023, class C & D non-notified devices will become notified devices and hence will require full product registration

Who should make this Communication?

Manufacturer

Authorized Representative

When to make this Communication?

Before placing a medical device into the market.

Market Access Requirements

Commencing October 1, 2023, the acquisition of an MD-14/15 Import License becomes obligatory for all Class A (Measuring and Sterile), B, C, and D medical devices intended for importation. The MD-14 application procedure mandates the submission of a comprehensive Device Master File (DMF) specific to each product, along with a Plant Master File (PMF) providing details about the manufacturing facility. 

Upon a meticulous approval process, an MD-15 Import License will be issued to a local license holder for the manufacturing site, covering a comprehensive list of all approved medical devices.

As outlined in the Circular (PDF) released on October 12, 2023, it has been specified that non-Notified Class C and D medical devices enlisted in the mandatory registration program, and concurrently undergoing a pending MD-14 application, are granted permission to continue their importation activities for a period of six (6) months.

How OMC Medical can assist you with the Process?

Act as your Authorized representative

Why Choose Us?

Working towards client satisfaction

Cost effective solutions

Project completion before deadline

Quality Regulatory affairs solutions

Contact us for free consultation: info@omcmedical.co.uk

Get more detailed information here: https://omcmedical.com/india-medical-device-registration/

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The Importance Of ADR Monitoring Via CDSCO Certification

The CDSCO Certificate ensures drug safety even after certification via ADR Monitoring. CDSCO License is specifically essential for importers that are operating the drug distribution chain at an international level.