Amendment in the Drug Rules, CDSCO, MDR India
This article is about MDR India for a notice published in the Indian Gazette on June 14, 2022, by the Indian Government’s Ministry of Health and Family Welfare. The CDSCO is requesting feedback and suggestions from individuals who are likely […]
Read MoreReclassification of Medical Equipment in Australia
This article discusses about the TGA Regulation the transitional steps that sponsors of medical devices intended to be used in direct contact with the heart and central circulatory system must do in order to be in compliance with new laws […]
Read MoreNew Framework to Manufacture Innovative Medicines in the UK
This article is about the EU MDR Regulation – Medicines and Healthcare Products Regulatory Agency (MHRA) announcing that the UK will be the first country to introduce a tailored framework for the regulation of innovative patient care products. As per […]
Read MoreFAQ 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 […]
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