In India, Medical Devices are regulated by the Central Drugs Standard Control Organization (CDSCO). Only the Notified Medical Devices have been regulated until now (there are 37 in this list), mainly concentrated on implantable devices. The CDSCO published the Medical Device Rules, 2020, on February 11, 2020, as an amendment to the Medical Device Rules, 2017, stating that all Non-Notified Medical Devices voluntary registration over 18 months. On October 1, 2021, the 18-month voluntary phase ends. There is no need to pay any government fee for this voluntary registration in CDSCO. It is a simple process that requires two primary documents: ISO and FSC. This process will generate a file number on the same day of application and is open for a limited period. The CDSCO released a new gazette notification about the Voluntary Registration in CDSCO deadline on September 21, 2021, which is coming up on September 30, 2021—the latest circular talks about the steps to obtain a Non-Notified File Number.
Documents Required For Medical Device Voluntary Registration In CDSCO
There are different documentation required for Manufacture and Importer, check out the documents as mentioned below:-
For Voluntary Registration of a Medical Device, the following documents must be uploaded on the portal by the Manufacturer-
- Name and Address of the company, manufacturing site, or firm
- The medical device details, such as
- Generic Name
- Brand Name
- Model no.
- Intended use
- Class of medical device
- Material of Construction
- Dimension
- Shelf life
- Sterile or non-sterile
- National Accreditation Board for Certification Bodies or International Accreditation Forum accredited the Certificate of Compliance with ISO 13485 standard for such medical devices.
- Undertaking: The undertaking signed by the manufacturer mentions that the information furnished by the applicant is genuine and authentic.
For Voluntary Registration of Medical Devices, These documents are required to be uploaded on the portal by the Importers:-
1. Name and address of the company, firm, or any entity importing the medical device
2. The medical device details, such as
- Generic Name
- Brand Name
- Model no.
- Intended use
- Class of medical device
- Material of Construction
- Dimension
- Shelf life
- Sterile or non-sterile
3. National Accreditation Board for Certification Bodies or International Accreditation Forum accredited the Certificate of Compliance with ISO 13485 standard for such medical devices.
4. Free Sale Certificate from the Country of Origin.
5. An undertaking from the importer that the applicant’s information is accurate and true.
Procedure For Medical Device Voluntary Registration In CDSCO
According to Rules 19C and 19E of Chapter IA in the Medical Devices (Amendment) Rules, 2020, the manufacturer or importer should upload the required documents on the online portal. Then, the CDSCO generates the registration number for the medical device. The details are uploaded to the “Online System for Medical Devices” after furnishing; the manufacturer and importer shall get the registration of medical devices. They must also specify the received registration number on the device’s label.
The CDSCO voluntary registration procedure can be followed only for non-notified medical devices. For Voluntary Registration of Medical Devices, the applicant should follow the following procedure-
1. First, the applicant should visit the online portal of the official CDSCO website, SUGAM Portal.
2. Next, the applicant must select the registration link from the portal to proceed
3. Upon selecting the link, then the applicant must register their Name, Email ID, and Mobile number
4. After that, the applicant should upload the following documents-
I.D. proof,
Undertaking
Corporate Address Proof Details (Certificate of Incorporation of the company)
Manufacturing and Wholesale License copy
5. After completing the uploading of details, the applicant shall be needed to verify the registration via a 4-dig OTP received on the registered mobile number
6. After the registration, the applicant will be able to log into their account
Period And Validity For Medical Device Voluntary Registration In CDSCO
The validity time of Voluntary Registration of Class A and B medical devices will be till September 30, 2022, Per the guidance document published by CDSCO On September 21, 2021. Class A and B medical device registration will be mandatory from October 1, 2022. Class A and Class B device registration is first voluntary for 18 months; then, it will be needed for 12 months. The validity time of voluntary registration for class C and Class D medical devices will be till September 30, 2023; Registration will be made mandatory from October 1, 2023. The manufacturers or importers should register Class C and Class D devices for 24 months After 18 months of voluntary registration.
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Rejection Of Medical Device Voluntary Registration In CDSCO
After providing the registrant the chance to explain why their registration should not be suspended or rejected, the registration number for a specific time may be canceled or suspended by the Central Licensing Authority. This could happen if the registrant fails to meet the requirements of the rules. The CLA also checks the document at all times to investigate the issue.
Conclusion
The government has issued an official notice regarding voluntary registration for medical devices to ensure that standards and good quality products are introduced to the market. Till the officially announced deadline, the voluntary registration shall apply to non-notified medical devices. All medical devices shall fall into the mandatory registration category after the deadline is crossed.
What Is Voluntary Registration Of Medical Devices?
There is no need to pay any government fee for this Voluntary registration. It is a simple process that requires two primary documents: ISO and FSC. This process will generate a file number on the same day of application and is open for a limited period.
What Are The Registration Guidelines For Cdsco?
Registration Guidelines. The form should be filled out by the organization’s Authorized Signatory / Responsible person. Submit a hard copy of the ID proof, Undertaking, and Address Proof Document to the CDSCO office. The CDSCO will approve the registration only after evaluating the submitted documents.
How To Register A Non-Notified Medical Device In India?
The Registration for non-notified medical devices is granted by the Central Drugs Standard Control Organisation (CDSCO), India’s regulatory authority. As per the provisions, an individual who wishes to obtain the registration number of non-notified medical devices must be required to apply through Sugam’s online portal.
How Mandatory Registration Is Different From Voluntary Registration?
While mandatory registration is a legal requirement once your turnover crosses the prescribed limits, voluntary registration can give strategic merits, such as enhancing market credibility, claiming input tax credits, and preparing for future growth.
How Many Types Of Registration Are There?
There are seven main types of company registration in India: sole proprietorship registration, one-person company registration, and partnerships and firm registration.