Medical Device Import License

Overview of Medical Device Import

In recent times, India has emerged as a frontrunner in the pharmaceutical sector, presenting limitless prospects for growth in both production and research endeavours. Nevertheless, in a scenario where a nation possesses adequate capabilities to generate and formulate medicines, it becomes imperative for the Indian government to implement specific measures to curb the irresponsible utilization and misrepresentation of pharmaceuticals and cosmetic products. Consequently, a distinct set of regulations and guidelines has been instituted by legislation, regularly updated to enhance international trust in Indian pharmaceutical enterprises.

Therefore, the Drugs and Cosmetics Act from 1940 along with its corresponding regulations from 1945 granted the authority to issue licenses for manufacturing, selling, importing, exporting, and distributing drugs, cosmetics, and medical devices throughout the entire span of India. Presently, over 30 different categories of medical devices have been placed under the umbrella of regulation and notification as per the guidelines outlined in the Drugs & Cosmetics Act of 1945.

Medical Device Import License

The Central Drugs Standards Control Organization (CDSCO) holds the authoritative role in approving applications for granting permission to import medical devices into India. To bring in medical devices that have been officially designated, an import license in the form of MD-15 is essential and can be acquired from the CDSCO, in accordance with the provisions laid out in the Medical Devices Rule of 2017.

For importing designated medical devices, both the manufacturing site and the devices themselves need to be registered with the CDSCO. The process of obtaining the import license for medical devices necessitates the completion of Form MD-14 and its submission to the CDSCO. This endeavour must be facilitated by an authorized Indian agent who is required to possess a license either for manufacturing (with intent for sale or distribution) or for wholesale activities (sale or distribution) in alignment with the prescribed regulations.

To initiate this procedure, the designated agent is responsible for making an application for the grant of the import license. This application is facilitated through the Sugam online portal, as stipulated by the official procedure.

Eligibility For MD Import Registration?

Foreign Manufacturers intending to import medical devices into India are required to secure a Medical Device Import Registration Certificate, a process that mandates the appointment of an authorized Indian representative. This representative must hold a valid Medical Device Wholesale License (for sale or distribution) or a wholesale license (for sale or distribution) in accordance with the regulations outlined by the CDSCO. Additionally, this appointed representative holds the responsibility of initiating the application process for both the approval and subsequent renewal of medical device registration for import purposes within India.             

Benefits of Medical Device Import

1. Ensuring Product Quality and Safety: The primary objective of manufacturing medical devices is to offer patients devices that are both safe and of superior quality. The certification from CDSCO guarantees that these devices undergo thorough testing to identify vulnerabilities and assess their operational lifespan, thereby confirming their safety and quality. Hospitals bear the responsibility of confirming that each device functions flawlessly and is devoid of any harmful repercussions, as doubtfulness can pose significant risks. The regulatory body responsible for scrutinizing these devices invests months in the approval process, establishing patients' confidence in the authenticity and reliability of their medical equipment.

2. Address Substantial Requirements: India stands as a significant market for medical device production, drawing manufacturers from various global regions. In order to address the substantial demands, the Indian government heavily leans on foreign producers. Given the multitude of available products, the regulatory authority is leaving no room for compromise in product quality. This explains why the regulatory body has been established to address and correct instances of moderate and subpar product quality.

3. Facilitate Uninterrupted Post-Licensing Surveillance: The Drugs and Cosmetics Act mandates manufacturers and distributors to give utmost importance to adhering to the provisions of the Act, thereby guaranteeing on-site assessments of medical devices. Through obtaining a registration license, manufacturers can assist the audit team in pinpointing possible flaws, thereby sidestepping penalties for violations. This approach guarantees adherence to regulations and upholds patient safety.

4. Legal Safeguard through Adherence: As the requirement to obtain a manufacturing license for medical devices has been established as obligatory, domestic manufacturers in the nation found themselves continually compelled to uphold conformity with the stipulated regulations. Nonetheless, those who diligently maintain adherence to these regulations and directives need not be overly concerned. Their primary task involves preparing and distributing their products in alignment with the prescribed guidelines, and the subsequent management will naturally follow suit.

Documents Required for MD-14

• Label and IFU
• Statement of compliance
• CE certification for designs
• Essential Principles Checklist
• Animal studies Preclinical data
• A copy of the Plant Master File
•  Biocompatibility validation data
• A copy of the Device Master File
• Post Marketing Surveillance data
• Regulatory approvals, if necessary
• Certificate of full quality assurance
• Risk analysis and control summary
• Copy of latest inspection, audit report
• Details of the Authorised Indian Agent
• Stability validation data, Clinical evidence
• ISO 13485 certificate for quality assurance
• Certificate of incorporation/partnership deed
• Free sale certificate, duly apostille or notarized
• A valid copy of the Medical Device wholesale license
• Medicinal substances data if the device contains Drug
• Biological Safety TSE/BSE, Sterilization Validation data
• Device Design and Manufacturing process with flow chart
• Reference to predicate or previous generations of the device
• Batch Release Certificates or Certificates of Analysis of finished product
• Notarized copy of overseas manufacturing site or establishment or plant registration

Registration Process of MD-14

Step 1: Categorization of the Medical Devices: The initial phase of importing a medical device involves determining whether it necessitates registration according to the Medical Device Rules of 2017 and ascertaining its classification as either a regulated or non-regulated item. In cases where registration is obligatory, an assessment of the medical device must be conducted based on the risk-oriented categories mentioned earlier.

Step 2: Nomination of an Authorized Representative: In the pursuit of acquiring a medical device import license, a foreign manufacturer is precluded from directly making an application. The regulations mandate that the manufacturer does not have the authority to directly approach CDSCO for application submission.

Consequently, the manufacturer is mandated to collaborate with an authorized licensing agent, who could be either an entity or an individual. In this context, the manufacturer must confer power of attorney upon this agent, empowering them to apply in the manufacturer's stead, as well as interact with the licensing authority, presenting necessary data and documents on the manufacturer's behalf.

Step 3: Submission of Application using Form MD-14: Any importer of medical devices desirous of obtaining registration through the online portal must do so by filling out Form MD-14 with all necessary attachments. But, where the intent of the manufacturer/importer behind obtaining the registration is for training or research purposes, an application must be submitted in the form MD-16 for which the corresponding license certificate shall be issued in form MD-17.

Before initiating this application on behalf of the foreign manufacturer, the authorized agent of the importer must possess a Form 20 license for stock and sale, along with a Form 21 B license for sale and distribution under the framework of the Medical Device Rules of 2017.

Step 4: Grant of MD Import Registration in Form MD-15: After the examination of the application if the approving authority is of the view that the applicant's medical device in question is genuine, and manufactured in line with the pre-specified guidelines, then it may grant the registration followed by a notification to the applicant in the form MD-15. Any approval or rejection of the application shall be notified through the registered email ID.

In a similar vein, if the intention is to import investigational medical devices for treatment at government hospitals or statutory medical institutions, the application should be prepared in form MD-18. The corresponding license will then be acquired via form MD-19. Furthermore, for the import of medical devices in limited quantities meant for personal use, the appropriate course of action involves submitting an application using form MD-20. Following this, authorization will be granted under form MD-21.

Validity of MD-15

The authorization for importing medical devices, granted in the form of MD 15, remains valid indefinitely, meaning it is upheld permanently, as long as the requisite license retention fee is duly paid at designated intervals as outlined in the Second Schedule. The fee for retaining the license needs to be settled before the conclusion of every 5 years from the license issuance date unless any suspension or cancellation by the Central Licensing Authority occurs

Role of Agile Regulatory

Obtaining the Medical Devices registration could be a bit challenging due to the complex process of the documents required and the processes involved. However, with the right amount of guidance and consultation, you could easily acquire Medical Device registration within the prescribed time. At Agile Regulatory we are committed to helping budding entrepreneurs by enabling them to acquire business licenses smoothly and carry on their business.

Frequently Asked Questions(FAQs)