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CDSCO License

Snehita Shukla
| Updated: 21 Sep, 2022 | Category: CDSCO

Draft Amendment on Class-A Non-Sterile and Non-Measuring Medical Devices

Class-A Non-Sterile and Non-Measuring Medical Devices
Reading Time: 4 minutes

The Ministry of Health & Family Welfare[1] under The Government of India was notified on 20th September 2022, notifying the draft of amendments related to Medical Device Rules. The draft informs about the provisions related to registration of Class A Non-Sterile and Non-Measuring Medical Devices under the Medical Device Rules. As per the notification, a new chapter is inserted as Chapter IIIB in the rules, which regulates all non-sterile and/or non-measuring devices classified as Class-A medical devices under the First Schedule of The Medical Device Rules.

Overview of Medical Device Rules, 2017

CDSCO, or The Central Drugs Standard Control Organization, is the highest regulatory body in India that keeps a check on rules and regulations related to Medical Devices. CDSCO is responsible for approving licenses to manufacture and Import medical devices in India. To regulate the Import, sale, distribution, manufacture, clinical trials etc., the CDSCO has notified Medical Device Rules, 2017. The medical devices have also been classified into four classes according to the risk associated with each device. The risk-based classification of medical devices is as follows-

  • Class A- Low-Risk Devices
  • Class B- Low- Medium Risk Devices
  • Class C- Medium- High-Risk Devices
  • Class D- High-Risk Devices 

The Rules have been subject to various amendments till now. The ministry of health and family welfare issued another draft for amendment on 20th September 2022, which regulates the provisions for registration of Class-A Non-sterile and non- measuring medical devices and has inserted a new chapter as Chapter IIIB.

The new rules inserted under Chapter IIIB of the Medical Devices (… Amendment) Rules, 2022, shall be applicable for the registration of Class-A Non-Sterile and Non-Measuring Medical Devices as per Schedule I of the Medical Device Rules, 2017. The registration shall be done through an Identified Online Portal for the same purpose.

Documents to be submitted by the Manufacturer of Class-A Non-Sterile and Non-Measuring Medical Devices 

The documents which are to be uploaded on the portal of “Online System for Medical Devices” by the Manufacturer of Class-A Non-Sterile and Non-Measuring Medical Devices are as follows-

  1. Name and Address of the manufacturing site
  2. Details of the medical device, such as-
    • Generic Name
    • Brand Name ( If the device is registered under Trade Marks Act, 1999)
    • Model no. (If any)
    • Intended use
    • Material of Construction
    • Dimension (If applicable)
    • Shelf life ( If applicable)
  3. Undertaking from the manufacturer that the proposed medical device is a Class A medical device (non-sterile and/or non-measuring), according to Schedule I of the medical device rules, 2017.
  4. Self- certification from the manufacturer stating that the medical device conforms to the essential principles checklist of safety and performance of the device
  5. Self-certification from the manufacturer states that the medical device complies with the standards prescribed in the medical device rules, 2017.
  6. Undertaking signed by the manufacturer stating that the information furnished by the applicant is genuine and authentic.

Documents to be submitted by the Importer of Class-A Non-Sterile and Non-Measuring Medical Devices 

The documents which are to be uploaded by the Importer of Class-A Non-Sterile and Non-Measuring Medical Devices on the portal of “Online System for Medical Devices” are as follows-

  1. Name and Address of the Importer and the manufacturing site
  2. Details of the medical device, such as-
    • Generic Name
    • Brand Name ( If the device is registered under Trade Marks Act, 1999)
    • Model no. (If any)
    • Intended use
    • Material of Construction
    • Dimension (If applicable)
    • Shelf life ( If applicable)
  3. Undertaking from the importer that the proposed medical device is a Class A medical device (non-sterile and non-measuring), according to Schedule I of the medical device rules, 2017.
  4. Self- certification from the importer stating that the medical device conforms to the essential principles checklist of safety and performance of the device
  5. Self- certification from the importer stating that the medical device complies with the standards prescribed in the medical device rules, 2017.
  6. Self-attested copy of the overseas manufacturing site or establishment or plant registration in the country of origin, issued by the competent authority or Free Sale Certificate issued by the National Regulatory Authority.
  7. Undertaking signed by the importer stating that the information furnished by the applicant is authentic.

Registration Process of Class-A Non-Sterile and Non-Measuring Medical Devices 

According to Rule 19H of Chapter IIIB of the Medical Devices (… Amendment) Rules, 2022, the manufacturer or Importer of Class A medical devices, including Non-Sterile and/or Non-Measuring medical devices, is required to obtain a registration from CDSCO. The manufacturer or importer must upload certain documents on the “Online System for Medical Devices”. After furnishing the information uploaded on the “Online System for Medical Devices”, the registration number for the medical device will be generated.

Essential points to be followed by the Manufacturers or Importers

While obtaining registration for Class-A Non-Sterile and Non-Measuring Medical Devices, there are some Essential points to be followed by the Manufacturers or Importers, which are as follows-

  • The manufacturer/importer is required to maintain the records of manufacturing or import along with the record of sales or distribution.
  • On request by Licensing Authorities, the manufacturer or importer is required to produce the records, Instructions and labels.
  • The Licensing Authorities may verify the documents or records at any time to investigate the quality or safety-related failures or complaints.

Rejection and Appeal of registration of Class-A Non-Sterile and Non-Measuring Medical Devices 

The State Licensing Authority/Central Licensing Authority may cancel or suspend the registration number for a certain period after allowing the registrant to show why the registration should not be rejected or suspended. This may happen if the registrant fails to comply with any rules or requirements.

The aggrieved person or individual may file an appeal to the State Government or the Central Government within forty-five days of the past order. The State Government or the Central Government then may pass an order to confirm, modify or reverse such order if satisfied by the appellant.

Conclusion

The draft issued by The Ministry of Health And Family Welfare under The Government of India is yet to be finalised after receiving objections and suggestions from any person who may be affected by the amendment. The regulation related to the registration of Class-A Non-Sterile and Non-Measuring Medical Devices has been introduced under the draft. The draft introducing certain rules to amend the medical device rules, 2017 is called Medical Devices (………Amendment) Rules, 2022. Under this, any manufacturer or importer of Class-A Non-Sterile and Non-Measuring medical devices must obtain registration for their individual purpose.

Read our Article:Application Procedure for Class A and B Medical Devices

Snehita Shukla

Snehita Shukla has completed UG in B.Com LLB from Central University, Bilaspur, CG and LLM (Corporate & Financial Laws and Policy) from OP Jindal Global University, Sonipat. She has a keen interest in Legal Research work. She is fluent in communication with both Speaking and Writing skills.

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