Overview of Used Medical Device Import License

• Cost-Effectiveness: Purchasing used medical devices can significantly reduce the costs compared to buying new equipment, making advanced technology more accessible.
• Environmental Impact: Reusing and refurbishing medical devices reduces electronic waste and the environmental footprint associated with manufacturing new devices.
• Resource Optimization: Refurbished devices can help healthcare facilities optimize their resources, especially in settings with budget constraints.
• Expanding Services: By reducing costs, importing used medical devices enables smaller clinics and rural healthcare facilities to expand their range of services, improving healthcare access in underserved areas.

Rules and Regulations referred for used medical device import license

• Central Drugs Standard Control Organization (CDSCO)
• Medical Device Rules, 2017
• Ministry of Health and Family Welfare, Government of India

Importing used medical devices into India requires a meticulous approach to ensure compliance with regulatory standards set by the Central Drugs Standard Control Organization (CDSCO). The following documents are essential for obtaining a used medical device import license:

Import License Application (Form MD-14).

• Description: It is used as the first and foremost application document that is required for the purpose of medical device imports into the country of India.
• Details Required: Additional information about the importer, the detailed description of the device, the information about the manufacturer, mode of use of the device.

Manufacturing License or Free Sale Certificate is one of the documents required to be produced to the government of India.

• Description: An official documentation that is produced from the country of origin to indicate that the device is legally sold or distributed in that country.
• Details Required: Documents which will assure that the device meets the standards of the country of origin for the regulation.

Device Master File (DMF)

• Description: A document that should contain all the relevant information that has been gathered about the medical device.
• Details Required: Design, fabrication, and construction methods, testing, inspection and quality assurance and the planned application.

Plant Master File (PMF)

• Description: A document that describes and explains all that a firm desires the manufacturing facility to come up with in the production process.
• Details Required: This comprises of architectural and designing information of the plant together with the manufacturing process, methods of checking and ensuring quality, and employees.

Certificate of Inspection

• Description: The same report from a certified body to assure that the devices is in good working condition as well as the safety measures being obeyed.
• Details Required: Type of inspection and findings, general status of the device and refurbishment works done.

Proof of Sterilization

• Description: Any document which may give a clearance that the device has undergone the appropriate sterilization process as recommended for use in medical line.
• Details Required: The manner in which sterilization is done, Can the tools mentioned above be certified, Is there a known body that certifies these tools for reuse.

ISO 9001/Quality Management Systems Certification

• Description: This kind of assurance that the importer and the refurbishing entity meet the requirements of a QMS that is acceptable, for instance, ISO 13485.
• Details Required: Certification documentation along with the procedures of the QMS that has been implemented.

Previous Ownership Records

• Description: Ownership history and maintenance history, the type and manufacturing date of the devise and many other things.
• Details Required: Data from former owners such as how and for what the bed was used, and services and repairs made.

Technical Specifications and Compliance Documents

• Description: Detailed technical specifications and documents proving the conformity of the medical devises with the Indian regulation.
• Details Required: Some of the items are technical drawings, specifications, and proof that an Ohio manufactured product complies with Indian standards.

Test Reports

• Description: Documentation proving the checking results of the device testing in the laboratories.
• Details Required: Outcomes of functional tests specialized tests as well as safety and performance assessments.

Invoice and Packing List

• Description: Business records of the specific deal.
• Details Required: The firm’s invoice outlining the purchase details and a packing list that indicates the contents of the shipment.

Declaration of Conformity

• Description: A signed statement from the manufacturer or its refurbisher to the effect that the device complies with the entire relevant standard.
• Details Required: By certified personnel, compliance with the current certification requirements and specifications is attained.

Letter of Authorization

• Description: This would be in form of an authorization letter under the circumstances where the manufacturer has given the importer a mandate to act on their behalf.
• Details Required: Authorization, which reflects the interaction and permissions on the official letterheads, in the signature line.

Conditions/Pre-requisites for Import of used/refurbished High End High value medical equipment:

• Form 5 of Hazardous and Other Wastes (Management and Transboundary Movement) Rules, 2016 as amended from time to time.
• The equipment must be enlisted in Ministry's O.M. dated 19* June, 2023, as advised by DGHS.
• Justification for import.
• The High End High Value Used/refurbished Medical Devices having residual life of minimum 07 years, duly certified by a Chartered Engineer or a certificate from any accredited agency of exporting country indicating the functionality, manufacturing date, residual life and serial number, shall be allowed for import for reuse purpose.
• If being imported on returnable basis than undertaking for re-export, then specifying the time period.
• Details of previous import if there has been any and confirmation regarding their re-
• In case of capital items particularly medical equipment the fact that the machine has been refurbished at the OEM factory and after sales service is provided by the supplier/ importer.
• Acknowledgment for receipt of copy of import application from concerned State Pollution Control Board (SPCB)/ Pollution Control Committee (PCC).
• Certification from exporting company for accepting the re-export of defective or second hand EEEs, after the specified time.
• Document depicting the status of employment generation indicating the no, of people benefited.
• Extended Producer Responsibility - registration as producer if the BEEs to be imported are listed in Schedule-I of the E-Waste (Management) Rules, 2022 as amended from time to time.
• Copy of the previous latest permission issued by this Ministry, if any.
• Undertaking declaring that such equipment has not been phased out from the importing country and is not considered obsolete in that country.
• Undertaking declaring that such equipment does not contain any hazardous material/ substances listed under any international regulation/ law and or by government of India.
• OEM/Indian subsidiary of that equipment shall ensure the availability of hardware and software support including spare parts/consumables for the period of warranty and comprehensive maintenance contract (CMC).
• The equipment should have minimum warranty period of one year, followed by three years of CMC.
• OEM/Indian subsidiary must give in writing about the availability of spare parts/consumables.
• The equipment shall be disposed after the end of life as per the prevailing Hazardous and Other Wastes (Management & Transboundary Movement) Rules, 2016 as amended from time to time and E-Waste (Management) Rules, 2022 as amended from time to time.
• The importer has to obtain an import authorization from DGFT, wherever the import policy of such items is restricted under ITC(HS)/Foreign Trade Policy/Procedures and any other statutory NOC/clearances as applicable.
• The Customs Authority at the Air Cargos/Ports/ICDs shall verify the documents prior to clearing the consignments. They can also take action as per the Hazardous and Other Wastes (Management and Transboundary Movement) Rules, 2016 as amended from time to time and the Customs Act, 1962 against importers found to be violating the norms.

In case import application is made by third party on behalf of actual user, List/Mapping of End Users for each equipment must be provided and confirmed purchase order from end user should be available.

Importing used medical devices into India requires following a structured process to ensure compliance with the regulatory standards set by the Central Drugs Standard Control Organization (CDSCO). Here is a step-by-step guide to obtaining a used medical device import license in India:

Step 1: Preliminary Assessment

• Device Classification: Determine the classification of the medical device according to the Medical Device Rules, 2017. Devices are classified into four categories (A, B, C, and D) based on risk, with Class A being the lowest risk and Class D the highest.
• Regulatory Requirements: Review the regulatory requirements and guidelines specific to the classification of the device.

Step 2: Documentation Preparation

• For importing used medical devices in India. The importer should possess the documents which are mentioned above.

Step 3: Submission to CDSCO

• Submit Application: Submit the completed application form (Form MD-14) along with all required documents to the CDSCO.
• Application Fee: Pay the applicable fee for the import license as specified by CDSCO.

Step 4: Review and Inspection

• Documentation Review: The CDSCO will go through all the documents submitted with a view of assessing their comprehensiveness and compliance to set regulatory requirements.
• Inspection: The CDSCO may inspect the device alongside the place of its storage or utilization to confirm the declaration and compliance to safety and quality standards.

Step 5: The roles include Approval and Licensing.

• Approval: When the CDSCO is content with the schedules kept in the application and the inspection findings, the application will be approved.
• Issuance of Import License: On the license being granted, the CDSCO will grant the import license this makes it possible for the device to be imported into India and used.

Step 6: Post-Licensing Compliance

• Record-Keeping: Preserve records of the computer devices that are imported and the usage and maintenance history and any adverse effects that may have resulted from their use.
• Adverse Event Reporting: To follow the regulatory requirements of the CDSCO report any adverse events or malfunctions that are related to the device.
• Periodic Renewals: Make sure you renew the import license before the set CDSCO guidelines to avoid delays.

Document Management System: Whizseed could offer a secure platform for importers to upload, organize, and store all the required documents mentioned in the overview, such as the Device Master File, certificates, and test reports.

Application Assistance: The site could provide step-by-step guidance on filling out the Import License Application (Form MD-14), ensuring all required information is included.

Checklist Generator: The platform could create custom checklists based on the specific type and classification of medical device being imported, helping ensure all necessary steps are completed.

Regulatory Updates: Whizseed could offer a service that keeps users informed about the latest regulations and changes from bodies like the Central Drugs Standard Control Organization (CDSCO) and the Medical Device Rules.