FAQs on Medical Devices Rules, 2017 – CDSCO Clarifications
Below are some key Frequently Asked Questions (FAQs) as answered by the Central Drugs Standard Control Organization (CDSCO) regarding the applicability and interpretation of the Medical Devices Rules, 2017 in India.
Q: Whether for a Medical device which is supplied in non-sterile state, the expiry/shelf life is mandatory on its label?
A: For the Medical Device which is supplied in non-sterile state, the date of expiry/shelf life on the label of such device may not be necessary.
Q: Whether the validation and QC data of medical device generated by the manufacturer for the medical device which is marketed in the country prior to implementation of the mandatory licensing regime under MDR, 2017 can be considered for grant of manufacturing license in the country?
A: Yes, if the data is found satisfactory by the Licensing Authority. For such cases, test license in Form MD-13 is not mandatory.
Q: In case of change of constitution of the company/firm holding the manufacturing license under the MDR-2017, whether fresh license is required?
A: Yes. The licensee shall inform the Licensing Authority about such change within 45 days and submit an application under MDR-2017 within 180 days from the date of change. The existing licence shall be deemed valid until a fresh licence is issued or the application is rejected.
Q: Whether the applicant can submit a single application for multiple actual manufacturing sites for obtaining import license?
A: No. A separate application with requisite fees and documents must be submitted for each manufacturing site.
Q: In case of change in the location of manufacturing site of the manufacturer, whether a fresh license is required?
A: Yes. The manufacturer must obtain a fresh manufacturing license under MDR-2017.
Q: Whether wholesale licence in Form 20B/21B under Drug Rules, 1945 or Registration certificate in Form MD-42 under Medical Devices Rules, 2017 is mandatory for Class A (non-sterile and non-measuring) medical devices?
A: No. These devices are exempt from Chapter XI (Sale of Medical Devices) requirements.
Q: Whether the manufacturer of medical devices requires ISO 13485:2016 certificate for obtaining a manufacturing license under MDR-2017?
A: No.
Q: Whether medical devices intended by its manufacturer to be used specially for animals are also regulated under Medical Devices Rules, 2017?
A: Yes.
Q: Whether CDSCO provides any consultation system for Start-ups/ Innovators/ Importers/ Manufacturers?
A: Yes. CDSCO has a Public Relation Office (PRO) cell at its headquarters to assist startups and others in understanding regulatory pathways for medical devices.
๐ Visit PRO Page | ๐ง Email: startupinnov@cdsco.nic.in
Q: What is a License granted for the purpose of Clinical Investigations or Test or Evaluation or Demonstration or Training under MDR-2017?
A: Form MD-13 is issued for manufacture and Form MD-17 for import, for such specific purposes under MDR-2017.
Q: Whether the License granted in Form MD-13/MD-17 for the purpose of Clinical Investigations or Test or Evaluation or Demonstration or Training under MDR-2017 is issued in perpetuity?
A: No. The license is valid for three years from the date of issue.
Q: What is Central Medical Device Testing Laboratory (CMDTL)?
A: CMDTL is a medical devices testing laboratory established or designated by the Central Government under Rule 19 of MDR-2017.
Q: If a device is complying with ISO/IEC standards, would it still need to follow BIS standards?
A: Yes, if BIS standards are available, they must be fulfilled. ISO/IEC standards apply only when BIS standards are not available.
Q: In case there is no BIS/ISO/IEC standard for medical devices, then which standard is to be followed?
A: The device shall conform to any other pharmacopoeial standards or validated manufacturer’s standard.
Q: Who is responsible for the submission of Post Marketing Surveillance (PMS) data?
A: The license holder is responsible for submitting PMS data to the Licensing Authority.
The Central Drugs Standard Control Organization (CDSCO) has released an updated set of Frequently Asked Questions (FAQs) to simplify the understanding and implementation of Medical Device Rules. This document aims to provide clarity on various aspects, including definitions, registration, import/export requirements, and compliance regulations for medical devices in India.
Key Highlights:
Definitions and Classifications:
- Medical devices are categorized based on their intended use and risk associated with their usage.
- Devices are classified into Class A (low risk), Class B (low-moderate risk), Class C (moderate-high risk), and Class D (high risk).
Registration and Licensing:
- All medical devices must be registered with the CDSCO.
- Manufacturers and importers need to obtain necessary licenses and comply with relevant standards and guidelines.
Import and Export Regulations:
- Specific requirements must be met for the import and export of medical devices, including obtaining an import license and adherence to quality standards.
- Exporters must ensure compliance with the importing country's regulations.
Compliance and Standards:
- Medical devices must adhere to national and international standards for safety and efficacy.
- Regular audits and inspections are conducted to ensure compliance.
Post-Market Surveillance:
- Manufacturers are responsible for the post-market surveillance of their devices to monitor performance and report adverse events.
- Proper mechanisms should be in place for timely reporting and corrective actions.
Quality Management Systems (QMS):
- Implementation of a robust QMS is mandatory for all manufacturers.
- The QMS should cover all aspects of production, from design and development to distribution and post-market monitoring.
Regulatory Pathways:
- Details on the regulatory pathways for different types of medical devices, including new and existing devices, are provided.
- The pathways outline the steps for obtaining necessary approvals and certifications.
Innovative and Emerging Technologies:
- Guidelines for the approval and regulation of innovative and emerging medical technologies are included.
- These guidelines ensure that new technologies are assessed rigorously for safety and effectiveness.
Compliance with ISO Standards:
- Adherence to ISO standards is emphasized for ensuring global compatibility and acceptance of Indian medical devices.
- Regular updates and training are recommended for staying compliant with the latest standards.
Common Queries:
- The FAQs address common queries related to the registration process, documentation requirements, and timelines.
- Clarifications on specific scenarios and exceptional cases are also provided.
