Apply For Class A Medical Device Registration

How Can I Apply For Class A Medical Device Registration?

If you are dealing with a Class A medical device, then you must apply for Class A Medical Device Registration in India. Without this license, you are not allowed to sell in the Indian market. Class A indicates the low-risk devices. So, if you are going to deal in this class In India, then go with the mentioned details to get a license for medical devices.

Steps To Apply For Class A Medical Device Registration

Through the CDSCO SUGAM portal, we can apply for class A medical devices. The following steps are used for CDSCO registration for class A devices.

  • To register a class A medical device, go to the CDSCO SUGAM portal.
  • Select the registration link.
  • Use a valid email address and phone number to register.
  • Upload the required documents such as ID proof, Undertaking, Corporate address proof(certificate of incorporation), Copy of manufacturing license, and wholesale permit  ( if applicable, or justification for not having them)
  • The OTP is received on your mobile when you complete the registration.
  • Log in to the CDSCO SUGAM portal and then further proceed with the CDSCO voluntary registration process.

What Is Class A Medical Device Registration?

Manufacturers or importers whose products come under the category of class A can apply for class A medical device registration. Class A medical devices indicate low-risk devices. Applicants will receive the register number after registering in the SUGAM portal for a class A medical device. They use the register number on the corresponding class A  medical device label.

List Of Class A Medical Device

Medical devices with low risk are followed by,

  • Nasopharyngeal catheter/ nasopharyngeal – used to remove air choke or obstruction by passing through the nares and to the depth of the nasopharynx.
  • Surgical dressing – used for dressing
  • Umbilical occlusion device – it is a clip, tie, or tape used to close the umbilical cord blood vessel.
  • Bolster suture – it is used during surgery to hinder pressure.
  • Alcohol swabs – it is used for scrubbing and drying

Why Do You Need Class A Medical Device Registration?

The purpose of class A medical device registration is to ensure that class A medical devices meet all the requirements by the CDSCO before they reach the consumer. So, the consumer gets quality and safe products.

Documents Required For CDSCO Registration For Class A Devices For Manufacturer

The following documents are required for CDSCO registration for the class A device for the manufacturer. Apply For Class A Medical Device Registration now and attach all the mentioned documents to avoid cancellation and suspension of application:

  • Name and address of the company and manufacturing site 
  • Medical device details that contain generic name, intended use, class, model number, dimensions, material of construction, shelf life, and whether it is nonsterile or sterile.
  • International Accreditation Forum (IAF) or National Accreditation Board for Certification Bodies accredited the certification of compliance with the ISO 13485 
  • The manufacturer signs an Undertaking duly that states whether the proposed medical device is class A (nonsterile and nonmeasuring) or not.
  • Manufacturer self-certification. The product confirms the essential principles checklist of safety and performance of the devices that are stated by this self-certification.
  • Manufacturer self-certification. This self-certification states Compliance with the standards specified in MD rules, 2017. 
  • The manufacturer signed the undertaking duly. The information furnished is authentic, as stated by this document.

Documents Required For CDSCO Registration For Class A Devices For Importer

To apply for Class A Medical Device Registration in India, you have to attach all the necessary documents with the application. The documents are as follows:-

  • Medical device importer name and address.
  • Medical device details include generic name, intended use, class, model number, dimensions, material of construction, shelf life, and whether it is nonsterile or sterile.
  • International Accreditation Forum (IAF) or National Accreditation Board for Certification Bodies accredited certificate of compliance with the ISO 13485 standard
  • Undertaking duly signed by the manufacturer that states whether the proposed medical device is class A (nonsterile and nonmeasuring) or not.
  • Manufacturer self-certification. The product conforms to the essential principles checklist of safety and performance of the devices that are stated by this self-certification.
  • Manufacturer self-certification. This self-certification states compliance with the standards specified in MD rules, 2017. 
  • Selfself-attested copy of the overseas manufacturing site or establishment or the competent authority-issued plant registration in the country of origin.
  • The national regulatory authority from the country of origin issued a free sale certificate.
  • The manufacturer signed the undertaking duly. The information furnished is authentic, as stated by this document.

Timeline For Class A Medical Device Registration

Generally, 6 – 9 months is the period for medical device registration in india. To obtain the medical device registration certificate, upload the complete and accurate documentation and post the registration fees.

Validity for class A medical device registration

The validity period for class A medical device registration is three years. Submit the renewal application before six months of expiry.

Conclusion

CDSCO plays a vital role in medical device registration, regulating approval and distribution of medical devices. It regulates medical devices with good quality and performance and makes rules and regulations. If the applicant needs to sell their device, they should follow the defined pathway. Rejection of application, gap penalized, or fined cause brand name loss and financial loss. So, the applicant should go through the document checklist, the steps to fill out the form, and the number of days it takes to get the application accepted to save time.

What Is The Cost Of Medical Device Registration In India?

The cost for one manufacturing site of class A or class B medical devices is 5000 INR. The price for each class A or class B medical device is 500 INR. The CDSCO defines the application fees for each category of medical devices.

How Many Classes Are There In Medical Devices?

According to the CDSCO rules, medical device categorization falls into four based on the risk, which are class A, class B, class C, and class D. This classification depends on the risk during the use of the device.

Who Approves Medical Devices In India?

CDSCO (Central Drug Standard Control Organization) under the ministry of Health and Family Welfare, Directorate General of health service, the government of india, is the NRA (national regulatory authority) of India-approved medical devices. 

What Are The Three Pathways To Medical Device Approval?

Premarket notification is known as 510(k) clearance, HDE (Humanitarian Device Exemption), PMA ( pre market approval). The majority of medical devices use these three pathways to get medical device approval.

What Is The Process Of Medical Device Approval?

To manage your device registration and interact with CDSCO on your behalf appoint an india authorized agent. Submit the device application and supporting documents to the CDSCO.

What Are Class A Medical Devices?

Class A medical devices are low-risk devices. Class A medical devices are low-risk devices with minimal or non-invasiveness, such as thermometers. Examples of class A medical devices include catheters, disposable perfusion sets, and surgical dressings.

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