Registration Number for Class A, Non - Sterile and Non-Measuring medical devices in India
Obtaining a registration number for Class A, non-sterile, and non-measuring Medical Devices can be a complex process. Our service simplifies it for you, providing expert assistance to ensure a smooth and efficient registration process. Let us help you obtain your registration number quickly and hassle-free.
Registration Number for Class A, Non - Sterile and Non-Measuring medical devices– Overview
The regulatory body governing medical device manufacturing licenses in India is the Central Drugs Standard Control Organisation (CDSCO). The CDSCO ensures that all medical device manufacturers and importers meet the requirements laid down for their devices before they reach the consumer. Anyone who desires to manufacture or import Class A, non-sterile and non-measuring, medical devices must register their Non-Notified medical device with the CDSCO. Therefore, they should apply at the online portal of the Ministry of Health and Family Welfare to get their registration number. The registration process involved in this is as follows:
- The manufacturer or importer must ensure that their product requires registration.
- After checking, the manufacturer or importer should complete the "Sugam Portal" registration.
- The manufacturer or importer should submit regulatory requirements as per Sections 2A and Section 2B.
- After providing the required information, the manufacturer or importer can immediately obtain the Registration number on the online system for their medical devices.
Who Can Apply?
Any India-based manufacturer or importer of medical devices whose product comes under the Class A (non-sterile and non-measuring) medical device category can apply for a registration number.
How To Apply?
The applicant should follow the following process:
- The applicant must ensure that their product requires registration and comes under Class A non-sterile and non-measuring medical devices.
- The applicant should fill in the required details in the online registration through the SUGAM portal.
- The applicant should submit the regulatory requirements as per Section 2A and Section 2B. The applicant should ensure that all the submitted documents are as per the requirements.
Fee Involved
The Government charges no registration fees from manufacturers or importers for registration of their Class A (Non-Sterile and Non-Measuring) medical devices.
Validity
The State Licensing Authority or the Central Licensing Authority has not defined the validity period for the license. Still, manufacturers and importers can use the registration number until the regulation has stringent rules.
Important Documents
Timeline to get Form from Central Drugs Standard Control Organisation
After providing the information requested in accordance with requirement, the Manufacturer or Importer can obtain the Registration number on the Online System immediately for Medical Devices created for this purpose
Essential Tips
The applicant must go through the essential principle (EP) checklist for medical devices.
The applicant must carefully prepare their documents for the registration, including the undertaking of medical devices, self-certification, and details of the overseas manufacturing site or establishment or plant registration.
Importers must have a Free Sale Certificate (FSC) when registering for their medical device.
The applicant might face certain problems in the registration process if the applicant does not provide the following documents:An undertaking stating that the proposed medical device is a Class A non-sterile and non-measuring medical device. The information furnished by the applicant must be true and authentic.
The applicant must self-certify the document confirming the product to the essential principle's checklist of safety and performance of such devices and comply with the standards specified in these rules.
Importers must provide a self-attested copy of the overseas manufacturing site, establishment, or plant registration.
Expert Advise
CliniExperts provides the following advice to its clients-
Manufacturers and importers should maintain the records related to manufacturing or import along with its sales and distribution.
Manufacturers and importers should have records, labels, and instructions for use per the licensing authorities' request.
The licensing authorities may verify the records and documents referred to in sub-rule (2) at any time and investigate quality or safety-related failures or complaints.
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Frequently Asked Questions
What will be the procedure to obtain additional products on an existing valid Registration Number?
You will need to submit separate applications to register for additional products.
What if the classification of a product being imported is different in GHTF countries from the classification in India?
In the cases where the classification of a product being imported is different in GHTF countries from the classification in India, the higher class of medical devices will be considered.
In the case of a multi-pack of a medical device, is it sufficient to provide a single IFU (Instructions for use)?
When offered for sale, the multi-pack of a medical device must either have its package insert or a user manual.
Will e-IFU (electronic Instructions for use) be permitted under the new regulations?
Yes, e-IFU (electronic Instructions for use) are permitted under the new regulations.
Can importers import Class A sterile medical devices on the basis of registration number?
No. Class A sterile medical devices can be imported based on an import license. The registration number will not meet the requirement.