CDSCO added eight medical device types to list of regulated devices
Central Drugs Standard Control Organization (CDSCO), Indiaexpands oversight to more types of medical devices, now planning to require registration for eight additional device types starting April 1, 2020. According to the new CDSCO notice, the following device types will require registration and import licensing under the Medical Device Rules, 2017: All implantable medical devices CT Scanning […]
US FDA finalizes Safety and Performance 510(k) registration route
FDA’s final guidance on what the agency calls its Safety and Performance Pathway is based on the Abbreviated 510(k) Program; FDA first announced plans to expand the Abbreviated 510(k) Program and published draft guidance in early 2018. Through this market authorization pathway, qualifying device manufacturers would be able to utilize performance criteria identified and approved by FDA to demonstrate […]
BSI-UK is designated as first Notified Body for the MDR
The British Notified Body BSI-UK is the first NB designated for the MDR, as can be seen in the European Database for Notified Bodies, NANDO. According to NANDO no NB has yet been designated for IVDs, but this may follow shortly. The designation covers all NBOG codes, and for all these codes BSI is designated for […]
US FDA issues a new rule that addresses post-market safety reporting obligations for combination products
USFDA has issued a final rule establishing the post-market safety reporting requirements specifically for combination products. These regulations for drugs, devices, and biological products share many similarities, however, each set of regulations has certain unique reporting requirements, standards and timeframes based in part on the characteristics of the type of product. The FDA’s new rule […]
ANVISA have introduced new clinical requirements for all novel medical device registrations and certain high-risk device
According to ANVISA’s recent announcement, the new clinical data requirements apply to qualifying devices submitted for review in both cadastro and registro registration routes. The key points from the technical notefor manufacturers are: Clinical data is now required for all novel devices. Some high-risk devices for which ANVISA determines safety and effectiveness may only be demonstrated via clinical […]
Malaysian MoH proposed an approach for registration of combination products
The Malaysian MoH has published a guidance regarding the regulation of combination products that include both pharmaceutical and medical device components i.e., ‘drug-device’ combination. As per this guidance document, the combination product’s market registration pathway is as per its primary mode of action. Hence, the products with pharmaceutical primary actions would fall under the country’s National […]
CFDA announces: Principle of technical review of medical device software
The CFDA has announced the release of its “Principle of technical review of medical device software” (2015 Order No. 50). This Principle applies to both stand-alone software and software components that are either developed by medical device manufacturers or their design and development partners, including any Off-The Shelf (OTS) software as part of the stand-alone […]
China FDA finalized the rules for priority on review program for some medical devices
The China FDA’s final rule on its priority review program for medical devices will come into force in January 2017. The CFDA’s final guidelineof the rule is open to Class III medical devices manufactured in China and Class II and III devices imported from foreign manufacturers. Chinese market registrants must apply for priority review qualification […]
SFDA: some borderline products shall be regulated as drugs rather than medical devices
The SFDA now regulates some borderline products as drugs rather than medical devices. The Saudi Arabian government has officially declared that it considers certain borderline products from medical device to be regulated as per pharmaceutical regulations according to a recent circular from the Saudi Food and Drug Authority (SFDA) The products identified below may no longer be […]
CFDA issues new document submission rules for Class II and Class III devices
The CFDA has issued new requirements for Chinese market authorization applicants who need to submit hard and soft copies of their registration applications to CFDA. According to the CFDA announcement, Chinese market applicants with Class II and III devices will have to submit not only their original registration dossiers, but also photocopies and soft copies in […]
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