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The Central Drugs Standard Control Organisation (CDSCO) has asked the medical devices manufacturers to re-submit fresh applications online for neutral code, Market Standing Certificate (MSC), and Non-Conviction Certificate (NCC) for approval, as it has switched the systems to provide auto-generated code and certificates to promote ease of doing business.
The drug regulator, in a public notice issued on April 9, said that in order to promote ease of doing business and to simplify the regulatory procedure, the provision for system auto-generated neutral code is being made functional under the Medical Devices Rules (MDR), 2017 through existing online system of medical devices portal.
The existing provision for issuance of neutral code, which helps the manufacturers to transport their medical devices to other countries without revealing their name or details, by the Central Licensing Authority will be non-functional from the date of implementation of the new procedure, said the regulator.
"Under the new provision, the manufacturer having a valid manufacturing license shall obtain neutral code through the option available in the approved manufacturing license from their dashboard for downloading the neutral code," said Dr Rajeev Singh Raghuvanshi, Drugs Controller General (India).
In view of this measure, the DCGI requested that all the concerned stakeholders obtain system auto-generated neutral code under the MDR, 2017, through the new provision in the online system of medical devices portal for export purposes.
Similarly, with the aim to promote ease of doing business and simplify the regulatory procedure, the DCGI in another notice on the same date, said that the current online application workflow for grant of MSC and NCC for medical devices licensed by Central Licensing Authority is upgraded in the online system, with new workflow for auto-generated MSC and NCC certificate.
"In this regard, all the current MSC and NCC applications received by CDSCO in the old workflow will be automatically rejected by the system," said the DCGI.
The drug regulator also requested all concerned stakeholders to re-submit fresh MSC and NCC applications from the date of issuance of this notice.
MSC is issued by the drug regulator to verify valid license of a manufacturer or importer for medical devices, and that it is active in manufacturing or importing and selling of medical devices. The certificate is proof that the company is creditworthy and has a good reputation in the country. Through this, the certificate is aimed at providing more business opportunities and a credible image in the export market.
The NCC is an assurance that the medical devices company is holding a valid manufacturing license and that it has not been convicted under the relevant rules and regulations existing in the country.
It may be noted that the CDSCO has switched the application for neutral code for manufacturing of medical devices for export purposes online through a notice issued in February, 2024. With this, in an effort to streamline the regulatory submission procedure, the drug regulator during the time asked the stakeholders to submit applications related to neutral code through an online system of medical devices portal only, from then on, under the MDR, 2017.
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