FAQ about Medical Device Registration in India
Introduction The process of medical device registration in India is regulated by the Central Drugs Standard Control Organization (CDSCO), which operates under the Ministry of Health and Family Welfare. All the medical devices must be registered with the CDSCO before […]
Read MoreApply for registration of a Refurbished Medical Device, Malaysia
This Article Deals about the Submission of Medical Device Application for Registration Published by Medical Device Authority of Malaysia. This manual was created to help the manufacturer and Authorized representative while registering a used medical equipment. A medical device must […]
Read MoreMedical Device Approval by Ministry of Public Health, Thailand
This Article deals with the Prescription for some Medical Device advertisements that don’t need medical device approval which is published by the Thailand Government. There are numerous regulations for medical device advertising that are intended to allow business owners to […]
Read MoreMedical Device Registration Authority Subscription, Malaysia
This Article deals with the Medical Device Registration in Malaysia. The Medical Device Registration Authority of Malaysia (MDA), also known as Medical Device Authority-Regulatory Information Subscription, released a notice on how to stay up to date with the MDA for […]
Read MoreNew Medical Device Registration Applications in Philippines
This Article deals with the New Medical Device Registration policy of the Philippines, Published by Food and Drug Administration on 27 September 2022. The latest Circular, provides guidelines on the abridged processing of medical device applications for registration with product […]
Read MoreSwiss Single Registration Number (CHRN)
This Article deals with the New Registration Policy of the Swiss Agency, published on May 22, 2022 by Swiss Medic. Medical Device Manufacturers are now needing additional consultants to assist them with the CHRN. Swissmedic, the Swiss Agency for Therapeutic […]
Read MoreExemption of Class A Non-Sterile/Non-Measuring Medical Devices from Licensing Regime
Introduction This Article deals with Class A Non-Sterile/Measuring Medical Devices which are now exempted from the MD-15 Requirement. The Ministry of Health and Family Welfare has released a new amendment to the Medical Devices Regulations (MDR) 2017. This includes provisions […]
Read MoreImport of Medical Devices into India
Introduction – Import of Medical Devices into India This article deals with the import of Medical Devices into India. The importation of Medical Devices in India is of prime importance for every manufacturer. In order to import into India, manufacturers have […]
Read MoreSoftware as Medical Device Update by TGA
The following article deals with the latest update for Software as Medical Device by The Australian TGA (Therapeutic Goods Administration). Software based Medical Devices (SaMD’s) are regulated by the TGA and must be included in the Australian Register of Therapeutic […]
Read MoreVoluntary Registration of Medical Devices in India
Introduction – Voluntary Registration of Medical Devices in India The Central Drugs Standard Control Organization (CDSCO) regulates Medical Devices in India. Until now, only the Notified Medical Devices have been regulated (there are 37 in this list) , mainly focusing […]
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