CDSCO Approval for Voluntary Registration of Medical Devices

In India, the regulation of medical devices is carried out by the Central Drugs Standard Control Organisation (CDSCO). The government authority has enlisted around 37 medical devices as per the latest notification. The CDSCO has made an amendment to the Medical device rules of 2017. The amendment stated that stakeholders could make a voluntary registration from February 11, 2020 – October 1, 2021. However, the CDSCO has extended this date by one year, and the new deadline is October 1, 2022. Suppose the manufacturer fails to obtain this registration before the deadline. In that case, they shall not be allowed to do their business and face a potential risk of paying hefty fines until they complete the registration. In this article, we shall explain CDSCO Approval for Voluntary Registration of Medical Devices. 

The necessity of CDSCO Approval for Voluntary Registration

The Voluntary registration of the medical devices just requires the manufacturer to obtain an ISO 13485. This shall be granted by either International Accreditation Forum (IAF) or National Accreditation Board for Certification Bodies (NABCB). The government believes it is high time to regulate the medical device industry in the country. For those reasons, it has not asked the manufacturers to produce safety past effectiveness data of the product. This move shall ensure that medical devices in the country meet the minimum requirement of ISO 13485 certification.

Note: ISO 13485 is applied to the quality management system for designing and manufacturing a medical device.

Entities who require to obtain CDSCO Approval for Voluntary Registration

The following entities need to make an application for CDSCO Approval for Voluntary Registration:

• Importers
• Sellers
• Manufacturers

Important Documents and information required for CDSCO Approval for Voluntary Registration

The applicant must provide the following information for the CDSCO Approval for Voluntary Registration:

• ISO 13485 Certificate
• Free sale certificate/ Certificate to a foreign government (applicable to imported medical devices)

This certificate is issued by the government of the country where the device is manufactured. It acts as proof that the medical device in question is sold freely in the country/ region.

• Undertaking (stating the information furnished in the application is true and best to the knowledge of the applicant)
• The manufacturer’s details (this must include name. address, email id and mobile number)
• Details of the Site ( name, address and contact information)
• Type of activity to be mentioned (import/export)
• The Device Category (medical device/ IVD)
• Generic name of the product
• Intended use of the device
• Description of the product
• Class of Medical Devices
• Medical device category
• The material used for construction
• Dimensions of the device (if applicable)
• Shelf life of the device
• Conditions to be maintained for the storage of the device
• Size of the package
• Sterile or Non-sterile
• Name of the brand (as per registration under the Trade Mark Act, 1999)

Process of CDSCO Approval for Voluntary Registration of medical devices

The voluntary registration is applicable only to non- notified medical products. A stakeholder (importer, manufacturer, and seller) must comply with the following steps to obtain CDSCO approval for the voluntary registration of medical devices.

1. The applicant must log in to the CDSCOs website and navigate to the registration page for voluntary registration.
2. Applicants need to click on the registration link provided on the website.
3. The applicant must have a functional email and mobile number in order to complete the registration process.
4. The portal shall verify the mobile number and email id. Once the verification is completed, the applicant shall be asked to provide the necessary details.
5. Next, the applicant must upload all the relevant documents as mentioned previously in this article.
6. Once the form is completed, the applicant shall be asked to verify the registration through an OTP received on the mobile number.
7. After the completion of the self-verification, the process of application to obtain CDSCO approval shall be completed.

Consequences of the Failure to obtain CDSCO Approval for Voluntary Registration

Every manufacturer, seller and importer of medical devices must obtain the CDSCO’s approval for voluntary registration. However, if the concerned stakeholders fail to complete the voluntary registration before the deadline, i.e. 22nd October 2022, then:

• Entities without the registration shall be asked to stop their operations in the Indian market and;
• These entities shall also be liable for penal action under the Drugs and Cosmetics Act, 1940^[1].

Fee charged by the government for Voluntary Registration

As of now, there is no government fee applicable for the voluntary registration of medical devices under CDSCO.

Validity of CDSCO Approval for Voluntary Registration

The voluntary license shall be valid till the manufacturer/ importer/ seller obtains a permanent CDSCO License.

• For Class A (low-risk) and Class B (low-medium risk) must obtain the license mandatorily before 30 September 2022
• For Class C (moderate-high risk) and Class D (high risk) must obtain the license mandatorily before 30 September 2023

Conclusion:

The government has introduced CDSCO voluntary registration to ensure that good quality ISO-certified products are brought into the market. The voluntary registration shall extend to only non-notified devices and till the time manufacturers, importers or sellers receive their licenses.

Read our Article:Manufacturing Registration for CDSCO Medical Devices