In January 2017, India’s Ministry of Health and Family Welfare released the long-awaited Medical Device Rules of 2017 (MDR 2017 or the Act), which took effect on Jan. 1, 2018. Upon implementation, this regulation replaced the existing Drugs and Cosmetics Act (DCA).
1 Four Classification Categories
Medical devices and in-vitro diagnostics will be classified into four categories, depending upon the indications for use and risk level of the device.
The new rules establish a risk-based approach, whereby the level of regulation varies considerably depending on the risks and technology associated with the device’s intended use and technological characteristics. Four classes (Class A, B, C, and D) have been established under the new framework, where Class A and B present the least risk and Class C and D devices present higher risk to patients.4 For example, an elastic bandage or a mechanical barrier used for compression or for absorption of exudates for wounds that have not breached the dermis and can heal by primary intention would be classified as a Class A device
2. DCGI determines device classification.
As compared to the U.S. Food and Drug Administration (FDA), the DCGI classifies all proposed medical devices.9 In the United States, manufacturers and importers classify their products for the purposes of registration and propose device classifications in marketing applications (although FDA has the ability to reject proposed classifications). Conversely, in India, the license authority will classify the medical device based on the intended use of the device and other factors, such as the invasiveness of the device, duration of device use, presence of an “active therapeutic/diagnostic,” and whether the medical device incorporates medicinal product/human cells/tissues/derivatives.
3. Inspections required for all new Class C & D
Inspections are required for all new Class C and D medical devices.
Similar to the requirements of the EU Medical Device Rules, before the government grants an entity a license to manufacture or distribute a device that is classified as either a Class C or D product, the manufacturing site will be inspected within a period of 60 days from the date of the marketing application by notified bodies or other delegated government entities to verify conformance with quality management system regulations. Further, an inspection report will be completed by the inspection team with recommendations and findings that will be provided to the licensing authority. Once the inspection report has been received, the government will have 45 days to either grant a license to manufacture/distribute the device or reject the application.
4. Devices must perform to standards.
All proposed medical devices will be expected to conform to performance standards.
Medical devices will need to conform to performance standards imposed by the Bureau of Indian Standards (BIS) or as prescribed by the Ministry of Health and Family Welfare in the Central Government. The rule further states that if there are no relevant standards recommended by BIS, then relevant standards released by the International Organization for Standardization (ISO) or the International Electro Technical Commission (IEC), or by any other pharmacopoeial standard would need to be followed. If no relevant standards exist, then the validated manufacturer’s standards will need to be used
5. Timelines have been specified.
The rules specify timelines for various actions. For example, the review of a marketing application for a Class C or Class D medical device must be completed within 45 days from the date of the online submission.13 Further, inspection of the manufacturing site for medical devices classified as Class C or Class D must be completed within 60 days from the date of the initial application.14 Furthermore, after completion of the inspection, the inspection team must forward the inspection report to the licensing authority, who then has 45 days to make a final approval determination.15 Setting forth timelines in the Act provides hope that the application process will be transparent
6. Licenses are perpetual.
Medical device licenses that are granted will remain valid in perpetuity, as long as license fees are paid every five years from the date of issue, unless the license is suspended or cancelled by the licensing authority.16 If the licensee fails to pay the required license retention fee on or before the due date, the entity will be liable to pay late fees in addition to the license retention fee. If the licensee fails to deposit the license retention fee within 180 days, the license is deemed to have been cancelled. Therefore, continuous monitoring of granted licenses is required
7. Prior approval for major device change
Prior approval is required for major medical device changes.
Major changes require prior approval from the appropriate licensing authority.
Examples of major changes include a change in material of construction, a design change that affects the quality, a change in the intended use or indications for use, a change in performance and stability, change in method of sterilization or approved shelf life, change of domestic manufacturer name, or change of manufacturing site. The licensing authority must approve or reject the change within 45 days
Minor changes (e.g., changes that will not affect quality) only require written notice to the appropriate licensing authority within a period of 30 days of making the change
8. Clinical investigation framework added
The Medical Device Rules have added a new regulatory framework for clinical investigations.19 The government requires that clinical investigations in humans be approved prior to initiation. Further, permission must be obtained to import or manufacture investigational medical devices to conduct clinical investigations.
Other notable provisions include:
The licensing agency has 90 days from the time it receives an application to conduct a clinical investigation to either approve or grant permission to conduct the study.
No approval is required for academic clinical studies on licensed medical devices where the Ethics Committee approves such a study and the data generated during the study is not used for a marketing application.
The rule has conditions that must be met
The rule has conditions that must be met once a clinical study protocol has been approved.
The clinical investigation must be initiated within a period of one year from the date of approval.
The clinical investigation must be registered with the Clinical Trial Registry of India before enrolling the first participant.
Annual status reports must be submitted to the licensing authority, including notification of termination of the study, and the reporting of suspected or unexpected serious adverse events occurring during the clinical investigation within 14 days of knowledge of its occurrence.