The Drugs Controller General of India (DCG(I)), India’s medical device and pharmaceutical market regulator, has appointed a new head of its Medical Device Division as well as a new Joint Drugs Controller, which could lead to more efficient registration processes in the country.

EMERGO 핵심 요약: 여덟 가지 유형의 의료기기가 인도 CDSCO 규제 의료기기 목록에 추가되었습니다. 가장 최근에 추가된 의료기기에는 이식형 의료기기, CT 스캐너, MRI 장비 등이 있습니다. 해당 의료기기는 2020년 4월 1일까지 CDSCO에 등록해야 합니다.

Emergo の キーポイントのまとめ： インド CDSCO 規制対象機器のリストに追加される8種類の医療機器。 ひとまとまりの最新機器には移植可能機器および、CT スキャナー、MRI 機器が含まれます。 これらの機器は2020年4月1日までに CDSCO に登録をしなければなりません。

EMERGO SUMMARY OF KEY POINTS: Eight medical device types added to India CDSCO list of regulated devices; Latest batch of devices include implantable devices, CT scanners and MRI equipment; These devices will have to be registered with CDSCO by April 1, 2020.

Emergo重点摘要： 印度监管机构打算扩大对其他类型医疗器械的监管。 印度CDSCO已将超声波和相关成像设备添加到其“医疗器械公告清单”中。 CDSCO尚未提供关于这些产品将于何时变成受监管医疗器械的时间表。

EMERGO SUMMARY OF KEY POINTS: Indian regulators intend to expand oversight to additional types of medical devices. The Indian CDSCO has identified ultrasound and related imaging equipment as additions to its List of Notified Medical Devices. CDSCO has not provided any timeframes for when these products will become regulated devices.

Emergo重点摘要： 印度CDSCO先发布的FAQ常见问题解答，针对新的2017年医疗器械条例合规事宜的多个问题进行了解答。 FAQ中涵盖的问题包括CDSCO仍在审核的医疗器械注册申请的状态、医疗器械公告列表更改和标准合规事宜。 印度2017年医疗器械条例将于2018年1月生效。

EMERGO SUMMARY OF KEY POINTS: A new FAQ from the Indian CDSCO addresses several questions regarding compliance with the new Medical Device Rules 2017. Issues covered in the FAQ include status of medical device registration applications still under review at CDSCO, notified medical device listing changes and standards compliance. India’s Medical Device Rules 2017 went into effect in January 2018.

L'organisme indien de contrôle des produits liés à la santé, le CDSCO, responsable de la supervision du marché des dispositifs médicaux en Inde, a ouvert un portail en ligne pour la présentation des certificats d'enregistrements et licences d'importation, afin de faciliter les parcours vers la commercialisation.

Die indische zentrale Kontrollorganisation für Arzneimittelstandards (Central Drugs Standard Control Organization, CDSCO) hat ein Online-Portal zur Einreichung von Registrierungsanträgen und Importlizenzen eingerichtet, um die Zulassungsverfahren zu beschleunigen.