Difference between Notified & Non-Notified Medical Devices

Notified & Non-Notified Medical Devices
Ganesh Nair
| Updated: Sep 02, 2022 | Category: CDSCO

CDSCO stands for Central Drugs Standard Control organisation. This entity is responsible for the regulation of drugs in India. CDSCO works under the ambit of the Directorate General of health services, which is governed by the Ministry of health and family welfare. CDSCO is responsible for conducting drug trials, keeping track of the quality of the imported drug, and laying down standards for drug manufacturers in the country. In this article, we shall look into the regulations of CDSCO regarding Notified & Non-Notified Medical Devices.

Notified medical devices

  • Meaning:

The medical device rules of 2017 have regulated devices; these devices are called notified devices. CDSCO is the government agency that is responsible for overseeing these medical devices. Till now, two notifications have been released by the CDSCO. The notifications have brought in significant changes in the regulations; these are:

  • A new definition of drugs and medical devices was announced – which widened the definition of medical devices, and now many aspects fall under it.
  • The CDSCO shall regulate all devices. Previously only 37 devices were listed to be regulated by CDSCO- hence they are called “newly Notified Devices.
  • Classification:

The second point of difference between Notified & Non-Notified Medical Devices is that according to the newly notified devices, there are 3 categories of IVD and 24 categories of medical devices. However, their division is into four classes. This division is based on the risk they pose to human life, with Class A being harmless till Class D being the riskiest.

  • Licensing authorities:

DCGI- Drugs controller general of India and CDSCO- Central Drugs Standard Control organisation[1].

  • License Requirements:

The domestic manufacturer must obtain a Manufacturing license (ML) to produce and sell the medical device in the country. The foreign manufacturer must obtain an import license (IL) to market its products in India.

  • Document Requirements:

ISO certification 13485:2016 and free sales Certificate from the country of origin are key documents that are required for notified medical devices, apart from the usual documents.

  • Regulatory Compliances:

The newly notified devices require the manufacturers and importers to get their devices registered by October 1, 2021. The mandatory registration for notified devices has a varying timeline; these are: for Class A and Class B devices (non-risk/ mild risk) have to be registered before August 11, 2022, whereas Class C and Class D (moderate risky/ high risk) can get their device registered by August 11, 2023.

  • Initiating licensing Activities:

It is recommended that the manufacturers must begin the licensing activities one year prior to the timelines enlisted by the government. It is suggested that Class A – Class B devices should start licensing process 3-6 months prior to the authorised date and Class C and Class D notified devices must start 5-7 months prior to the authorised date.

Non-notified medical devices

  • Meaning:

The major difference between Notified & Non-Notified Medical Devices is that Non-notified medical devices are every medical device that has not been mentioned under notified medical devices in the official gazette released by the government of India.

  • Classification:

There are a total of 1866 medical devices under the non-notified category as of now. Similarly, like notified devices, these are categorised into 24 medical devices and 3 In vitro diagnostic devices. These devices have also been classified based on their risk factor from Class A (least risky) to Class D (Most risky).

  • Licensing Authorities:

Licensing authorities include the State licensing authority (SLA) and the Centre Licensing Authority (CLA) in conformation with the DGCI.

  • License Requirements:

The stakeholders such as manufacturer, seller and importers must possess the manufacturing license, Wholesale license or retail license as applicable to deal with non-notified medical devices.

  • Document Requirements:

There is no significant difference in the documents between Notified & Non-Notified Medical Devices. The Main documents required for registration of Non-notified medical devices are similar to notified devices ISO certification 13485:2016, and free sales certificates are mandatory.

  • Regulatory Compliances:

The manufacturers of Non-notified medical devices must make a voluntary registration under the CDSCO. The government has not levied any fee on this voluntary registration. The earlier date for registration of non-notified medical devices was September 30 2021, which the authorities have extended by one year upon the request of various stakeholders.

  • Initiating licensing Activities:

It is advised that all the stakeholders apply for the Non-notified medical products registration immediately. Before the stipulated deadline, the manufacturer, importers, and sellers only have to produce ISO and FSC certifications with no registration fee.

Conclusion

The article listed the differences between Notified & Non-Notified Medical Devices. The regulatory authorities have made these differences based on the product’s need, risk, purpose and functionality. In a comparison between Notified & Non-Notified Medical Devices, the notified medical devices have a more stringent registration process, and the non-notified ones have a simpler registration process.

Read our Article:CDSCO Approval for Voluntary Registration of Medical Devices

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Ganesh Nair

Ganesh Nair completed his graduation in law from IP university. He is an ardent researcher who has written various research papers and articles on contemporary legal issues. His keen interest in the field of research made him pursue a career in legal research. His core area of interest include Cyber, IPR and Finance laws.

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