Par Stewart Eisenhart
LES POINTS PRINCIPAUX PAR EMERGO by UL :
Eine neue Anordnung der zentralen Kontrollorganisation für Arzneimittelstandards (Central Drugs Standard Control Organization, CDSCO) des indischen Ministeriums für Gesundheit und Familienwohlfahrt stellt manche Anforderungen in Bezug auf die Registrierung und auf klinische Studien von Medizinprodukten klar.
Zunächst wiederholt (Text auf Englisch) die CDSCO die 14 Kategorien an Produkten, die im Rahmen des Drugs and Cosmetics Act (Gesetz über Arzneimittel und Kosmetika) reguliert werden:
New orders from the Indian Ministry of Health & Family Welfare’s Central Drugs Standard Control Organization (CDSCO) clarify some requirements regarding the country’s sometimes opaque medical device registration and clinical trial regulations.
First, CDSCO has reiterated 14 categories of devices that do fall under India’s Drugs and Cosmetics Act and qualify for regulation:
Die indischen Arzneimittel- und Medizinproduktebehörden verlangen ab September 2014 die Kennzeichnung von importierten Produkten.
India’s drug and medical device market regulators will begin requiring importers to affix labeling information to their products before shipping to the country in September 2014.
Die indische Arzneimittelaufsicht (Drug Controller General of India, DCGI), die in Indien für Medizinprodukte und Arneimittel zuständige Behörde, hat einen neuen Direktor der Medizinprodukteabteilung und einen neuen Leiter der zentralen Arzneimittelaufsicht.
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.
India’s Central Drugs Standard Control Organization (CDSCO) has published new guidance documents covering registration and re-registration of notified medical devices, as well as guidances for manufacturing and import licensing.
Based on an initial analysis by Emergo Group, the medical device registration process in India generally remains the same. However, manufacturers should bear in mind several small changes:
Indian regulators are adding staff and resources to the Central Drugs Standard Control Organization (CDSCO) in order to enforce more stringent clinical trial guidelines for medical devices and pharmaceuticals.
India’s health ministry plans to push forward its proposed amendments to the country’s Drugs and Cosmetics Act that would
