India's CDSCO Issues New List of Medical Devices Under Medical Device Rules 2017
India’s CDSCO Issues New List of Medical Devices and provided clarity on classification of these devices, but the regulator appears to have broken down larger groups of devices such as “cannula” and “stents” into more specific sub-groups such as “ureteral stents” and “coronary stents.” CDSCO has classified these new sub-groups using risk assessment methods required by the Medical Device Rules 2017, still slated for early 2018 implementation.
Earlier manufacturers could sell medical devices in India without any jurisdictions. Since 2006 medical devices entering India must be incompliance with the Indian Medical Device Regulations set forth by the CDSCO. The CDSCO is responsible for India’s CDSCO Issues New List of Medical Devices of new drugs and clinical trials in the country laying down the standards for drugs.
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For manufacturers and/or importers who have already applied for manufacturing/ import license for any of these devices before December 27th, 2019 (Release of Notification for Extension of the Implementation- S.O. 4671(E)), applications shall be considered valid by the CDSCO. They can continue to import up to 6 months from issue of this order (i.e., up to June 28th, 2021) or until approval is granted for the submitted application, whichever is earlier.
India Medical Device Classification
Separate classification systems exist for Medical Devices and Invitro Diagnostic Devices (IVD). Each of these categories are classified into 4 classes based on the extent of risk associated with these devices.
| Device Class | Risk |
| A | Low Risk |
| B | Low Moderate Risk |
| C | Moderate – High Risk |
| D | High Risk |
Foreign manufacturers should appoint an Indian Authorized Agent (IAA) to market devices in India. The IAA shall possess active wholesale drug license in the 20B & 21B application forms. Foreign manufacturers may appoint their distributors or importers as the IAA. However, having an independent IAA, with no commercial interest, would provide required flexibility to appoint multiple distributors in India.
Both India’s CDSCO Issues New List of Medical Devices entrants as well as companies currently selling such devices in the country will have to register with CDSCO by the April 2020 deadline in order to continue legally marketing these products.
India’s CDSCO Issues New List of Medical Devices
All the applications for both Notified and Non-notified devices must be submitted through online portal called SUGAM and the CDSCO manages the applications through the same portal.
- Non-Notified Devices: The devices not included in the list of Notified Devices are not regulated in India. However, these devices shall be listed in the CDSCO portal. Foreign manufacturers shall have an IAA based in India to market these devices.
- Notified Devices: There are 37 categories of devices listed in Notified list, which are regulated by the CDSCO and require prior approval from the CDSCO for marketing them in India. There are different types of application forms and the documentation requirements vary with the application form submitted to the CDSCO.
The choice of application varies based on the home country approval, availability of Free Sale Certificate (FSC), nature of applicant, operations, and the type of device. After detailed evaluation of applications, the CDSCO issues licenses for either testing, import or for manufacturing of devices.
Notable Inclusions India’s CDSCO Issues New List of Medical Devices
While prior to the notifications in February, about India’s CDSCO Issues New List of Medical Devices and the CDSCO only regulated 37 medical devices, the current approach seems to be much wider with several commonly used products included in the list such as:
- Spectacles (frames and lenses)
- Contact lenses
- Public respirator masks (2 and 3-ply) – described as a filtering mask designed to be placed over the nose and mouth of a member of the general public to permit normal breathing while protecting the wearer from exposure to pathogenic biological airborne particulates during a public health medical emergency.
- The device, Fertility, Diagnostic, Contraceptive, and Software Application – described as software Designed to monitor and provide fertility information to prevent pregnancy (contraception) e.g., Clue, Flo and other available mobile applications.
While the relative inaction of the CDSCO with regard to the amendments has given medical device companies some time to adjust to the new India’s CDSCO Issues New List of Medical Devices, preparedness on the part of such companies would be key. As part of the application, they would be required to provide documentation such as: (a) a certificate of compliance with respect to the ISO 13485 standards (from an organization accredited by the National Accreditation Board for Certification Bodies or International Accreditation Forum); and (b) a free sale certificate from the country of origin of the medical device (applicable only to imported devices).
Companies should first assess whether their products fall within the list provided, and then make adequate arrangements with respect to the accompanying documents for the registration. Since these steps would have to be undertaken once the final Classifications are notified, companies would be well placed in keeping their documentation ready for the application.
Need assistance with India’s new medical device regulations? Contact Operon Strategist today for expert guidance on classification, compliance, and approvals to navigate the changing regulatory landscape smoothly.
FAQs:
What Is the Purpose of India’s CDSCO Updated List of Medical Devices?
The updated list of medical devices by India's CDSCO serves to provide a more precise and nuanced classification of medical devices based on risk assessment methodologies outlined in the Medical Device Rules 2017. This ensures better safety and efficacy evaluation of each device, enhancing regulatory oversight.
How Does the Updated Classification System Impact Manufacturers and Importers?
Manufacturers and importers who submitted applications for manufacturing or importing licenses before December 27th, 2019, will have their applications considered valid. They can continue importing these devices for up to six months from the order issuance or until their application is approved, allowing a transition period for compliance with the new regulations.
What Is the Significance of Appointing an Indian Authorized Agent (Iaa) For Foreign Manufacturers?
Foreign manufacturers intending to market devices in India are required to appoint an Indian Authorized Agent (IAA) who possesses an active wholesale drug license. This agent can be a distributor or importer. Opting for an independent IAA, without commercial interests, enables flexibility in appointing multiple distributors in India.
What Are the Key Steps for Compliance With the Updated Regulations?
To comply with the new regulations, entities, including both new entrants and existing companies selling medical devices in India, must register with the CDSCO by the April 2020 deadline. This registration process is facilitated through the online portal called SUGAM. It is crucial for companies to ensure their products fall within the updated list and to prepare the necessary documentation, such as certificates of compliance with ISO 13485 standards and free sale certificates for imported devices.
