Tag: regulatory

How FDA evidence standards work for NDAs, 505(b)(2) applications, ANDAs and biologics licenses, including accelerated approval and the animal rule.

The port filing, the customs clearance form and the testing that apply to a drug imported into China, with the periods for registration testing.

How 21 CFR part 820 became the Quality Management System Regulation, which sections were removed or reserved, and where each requirement now sits.

What a manufacturer files under Regulation (EU) 2017/745: Annex II and III technical documentation, the route by class and how notified bodies review it.

When an IND is required under 21 CFR Part 312, the exemptions, and the informed consent and investigator duties that govern FDA-regulated drug trials.

Breakthrough therapy, conditional approval, priority review and special approval for drugs in China, and which of them shortens a review period.

How 42 CFR Part 493 and the in vitro diagnostic definition in 21 CFR Part 809 treat a test that a laboratory develops, modifies and runs itself.

How Regulation (EU) 2017/745 requires manufacturers to run a quality management system, from design through surveillance, and who must oversee it.

What goes into a 510(k), De Novo, PMA or HDE submission to FDA, with format rules and review timeframes.

The national bodies that regulate drugs, devices, reimbursement, genetic resources and personal data in China, and what provinces handle.

How Article 5(5) of the IVDR allows a health institution to make and use its own in vitro diagnostic, and the nine conditions attached.

How Regulation (EU) 2017/745 governs post-market surveillance, PSURs, vigilance reporting deadlines and field safety corrective actions for medical devices.

How 21 CFR Part 820 applies the QMSR to device manufacturers, which devices need design and development controls and how combination products are treated.

How a drug clinical trial is cleared in China, from the 60-working-day rule and the 30-working-day channel to the filings that replace approval.

How Annex VIII of Regulation (EU) 2017/746 assigns in vitro diagnostics to classes A, B, C and D, and what each class determines.

How device class under Regulation (EU) 2017/745 sets the conformity assessment route, with the Annex IX, X and XI procedures and transitional deadlines.

How 21 CFR Parts 803, 806 and 822 govern adverse event reporting, corrections and removals and ordered postmarket surveillance for US devices.

The national fees for registering a drug or medical device in China, when they fall due, and the exemption for small and micro enterprises.

How FDA classification and special controls compare with IVDR performance evaluation in the evidence a single in vitro diagnostic has to generate.

How Regulation (EU) 2017/745 governs device claims, label particulars, sterile packaging text and the content of instructions for use.

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.