Tag: regulatory

How 21 CFR Parts 801 and 809 govern device claims and label content, from UDI and prescription statements to IVD package inserts.

The number of drug and medical device applications China's national regulator accepted and approved in 2025, and what each count measures.

How Regulation (EU) 2017/745 sets the clinical evidence for a CE marked device, covering clinical evaluation, investigations, equivalence and PMCF.

How CLIA certification, performance specification validation and personnel qualifications apply to a laboratory before it reports a patient test result.

What must be proven under each FDA device marketing route and the kinds of study that satisfy 21 CFR parts 807, 814 and 860.

Which medical device trials in China need approval from the national regulator, which need only a filing, and what each route requires.

How Regulation (EU) 2017/745 governs clinical investigations of medical devices, which studies it covers and when authorisation or notification is needed.

How 21 CFR Part 862 special controls separate analytical performance, clinical performance and claims about patient management for in vitro diagnostics.

How 21 CFR parts 812, 50 and 56 govern clinical investigations of medical devices, including when an IDE application must be submitted to FDA.

The statutory clocks for a security assessment, a standard contract filing and certification of data exports from China, and what extends each.

How Annex VIII of Regulation (EU) 2017/745 assigns medical devices to class I, IIa, IIb or III, and the rules that decide which class applies.

How FDA premarket routes divide between 510(k), De Novo and PMA, with the criteria, contents and review timeframes set by 21 CFR parts 807 and 814.

How FDA assigns devices to class I, II or III under 21 CFR Part 860, covering classification regulations, De Novo requests and 510(k) exemptions.

What China's commercial health insurance innovative drug list is, which drugs may apply to it, and what a place on the list gives.