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India’s New Medical Devices Rules Cheat Sheet by

India’s New Medical Devices Rules
rules     medical     new     devices     india-s

Introd­uction

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.

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