Central Drugs Standard Control Organization (CDSCO) has issued Medical Device Import Registration (FORM MD-14, OR MD-15) to an Indian importer and foreign manufacturer of medical devices and diagnostics having their registered office in India. Form MD-14 and MD-15 are the main documents required to obtain a medical device import license. Form MD 14 is an application form completed and submitted on the CDSCO web portal for class A to D medical device import license. If a foreign manufacturer wants to export medical devices to India, the application must be made through an authorized representative or distributor in India. This representative must have a valid Wholesale License (Form MD-42) authorizing the sale of medical devices in India. Form MD 15 is a CDSCO -approved permit to import medical devices into India according to their classifications A, B, C, and D and in vitro medical diagnostic devices into India. MD-15 is a mandatory requirement for importing any medical device into India.

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What is Medical Device?

India has recently emerged as a pioneer in the pharmaceutical industry and offers unlimited growth prospects in both manufacturing and research. However, in a situation where the country has sufficient capacity to produce and formulate medicines, there is a need for the Government of India to take special measures to curb the irresponsible use and counterfeiting of medicines and cosmetics. Therefore, separate regulations and guidelines have been legislated and updated regularly to increase international confidence in Indian pharmaceutical companies.

Therefore, the Drugs and Cosmetics Act of 1940 and its corresponding regulations of 1945 authorized the manufacturing of drugs cosmetics, and medical devices, sales for import, export, and distribution throughout India. Currently, more than 30 different categories of medical devices are regulated and notified under the guidelines of the Drugs and Cosmetics of 1945.

The Central Drug Standards Control Organization (CDSCO) plays an authoritative role in approving import license applications for medical devices in India. Importation of officially designated medical devices requires an MD-15 Import permit obtained from CDSCO under the provision of the Medical Devices Rule 2017.

Imports of designated medical devices must include both the place of manufacture and the devices themselves must be registered with CDSCO. Form MD-14 must be completed and submitted to CDSCO to obtain an import permit for medical devices. This company is promoted by an authorized representative in India authorized either for manufacturing (for sale or distribution) or for wholesale operations (sale or distribution) as per the prescribed form and regulations.

To start this, the designated representative is responsible for applying for the issuance of the import certificate. This application is facilitated through the SUGAM website as per the official procedure.

Read Our Blog: CDSCO Medical Device Import License and Registration

Eligibility For Medical Device Import Registration

Foreign manufacturers intending to import medical devices into India are required to obtain a medical import registration certificate. This process requires the appointment of an authorized representative in India. This representative must have a valid Medical Device Wholesale Permit (for sale or distribution) or Wholesale License (for sale or distribution) by the rules set by CDSCO. In addition, this designated representative is responsible for initiating the application process for approval and renewal of registration of medical devices imported into India.

Benefits Of Medical Device Import

• Ensuring product quality and Safety: The primary goal of medical device manufacturing is to provide patients with devices that are thoroughly tested to identify vulnerabilities and assess their lifespan, ensuring their safety and quality. Hospitals are responsible for ensuring that all equipment is working properly and that there are no adverse effects, as doubts can create serious risks. The regulatory body responsible for overseeing these devices invests months in the approval process, strengthening patients’ confidence in the authenticity and reliability of their medical devices.
• Display important claims: India is an important market for medical device manufacturing that attracts producers, from various regions of the world. The Indian government relies heavily on foreign manufacturers to meet the significant demand. With many products available, the regulator leaves no room for compromise in product quality. This explains why a regulatory body was created to address and correct cases of moderate and substandard product quality.
• Facilitates Uninterrupted Post-Licensing Monitoring: The Drug and Cosmetics Act requires manufacturers and distributors to pay the utmost attention to compliance, and on-site evaluation of medical devices is guaranteed. By obtaining a registration license, producers can help the audit term identify potential deficiencies and avoid penalties for violations. This approach ensures compliance and maintains patient safety.
• Legal Protection through Compliance: Since the requirements to obtain a medical device license have become mandatory, the country’s domestic manufacturers had to continuously comply with the prescribed regulations. But those who follow these regulations and directives diligently need not worry too much. Their main job is to manufacture and distribute their products according to prescribed guidelines, and future management will naturally follow suit.

Read Our Blog: Classification of Medical Devices by CDSCO in India

Steps Involved In The Registration Process Of MD-14

Step 1: Classification of medical devices: The initial step in importing a medical device is to determine whether it requires registration under the Medical Devices Regulations 2017 and to classify it as a regulated or non-regulated product. In cases where registration is mandatory, the evaluation of the medical device must be done based on the aforementioned risk-weighted categories.

Step 2: Appointment of an Authorised Representative: When obtaining an import permit for a medical device, a foreign manufacturer cannot apply directly. The rules state that a producer may not contact CDSCO directly to apply. Thus, the manufacturer has the right to work with an authorized licensing agent, which can be either an entity or an individual. In this regard, the manufacturer must provide this representative with a power of attorney, which authorizes him to submit the request on behalf of the manufacturer communicate with the licensing authority, and provide the necessary information and documents on behalf of the manufacturer.

Step 3: Delivery of Applications Using Form MD-14: All importers of medical devices who wish to register through the online portal must do so by completing Form MD-14 and all necessary attachments. However, if the intention of the manufacturer /importer behind the registration is for educational or scientific purposes, an application in Form MD-16 must be submitted, for which a corresponding license certificate in Form MD-17 will be issued. Before submitting this application, the authorized representative of the importer on behalf of the foreign manufacturer must have a Form MD-20 license for storage and sale and a Form 21-B license for sale and Distribution under the Medical Devices Regulations 2017

Step 4: Issuance of MD Import Registration Form Md-15: After reviewing the application, the Type Approval Authority determines that the relevant medical device of the applicant is genuine and manufactured according to the preparations. He may approve the registration and send the applicant a notice on Form MD-15. The acceptance or rejection of the application will be notified through the registered email address. Similarly, an application must be submitted as Form MD-18 if research-related medical devices are imported for the treatment of public hospitals or statutory treatment facilities. Then the corresponding license is obtained using the MD-19 form. In addition, when importing limited quantities of medical equipment for personal use, it is appropriate to apply Form Md-20. After that, a permit is issued on the MD-21 Form.

Read Our blog: Permission to Import Devices: Form MD-14 and Form-15

Obtaining A Medical Device-15 License In India

The medical device import permit issued in form MD-15 is valid indefinitely, i.e. it is valid permanently provided the required license maintenance fee is paid at the intervals described in the second schedule. The license maintenance fee must be paid every five years before the license is issued unless suspended or revoked by the central licensing authority. In India’s ever-evolving regulatory environment, obtaining a medical device import license is an important step for manufacturers looking to enter the market. Since the introduction of the Medical Devices Regulations in 2017, all medical devices and in vitro diagnostics require Class A, B, C, and D classifications and subsequent import licenses for marketing in India. Indian authorized representatives in India also act as legal importers and apply for an import permit through Form Md-14 through the SUGAM portal Once approved, they will receive an MD-15 import license, marking them as the importer of the device. The application includes:

• Issue of authorization of the Indian representatives
• Filing of Form MD-14 in the SUGAM portal
• Submission of document by device category
• Payment of fee
• Answering of Questions
• End of MDAC review of innovative products
• Obtaining an import license for MD-15
• Export medical devices to India.

Documents Required For The Medical Device Registration Process

• Information about the application, including names and addresses of company managers, and the premises.
• Copy of Site master file and device master file in appropriate format
• Smart Regulatory checklist copies of ISO 13885 certificate obtained by the company for manufacturing facilities
• A detailed explanation of the manufacturing process of the manufactured equipment
• The qualifications and experience of the technical staff under whose supervision the device is manufactured
• Product details such as brand name or proprietary name and equipment class
• Method of use and intended use, details of material used, variations in device style, size, or shape, recommended storage conditions, a brief description of the device
• List of accessories and other devices and equipment used with the device, including package description and labelling of the package containing the size by the Narcotics and Cosmetics Act 1940 and Regulations of 1945.

Conclusion

Obtaining a medical device registration can be somewhat difficult due to the complexity of the required documents and processes. However, with proper guidance and consultation, you can easily register your medical device within the stipulated time. At Corpseed, we are dedicated to helping them to smoothly obtain licenses and continue their operations.