FDA New Pilot Program for Medical Device Conformity Assessment Accreditation
By September 20120, the US Food and Drug Administration (FDA) is planning to lanch its pilot program for medical device conformity assessment accreditation, known as the Accreditation Scheme for Conformity Assessment (ASCA).
New FDA Pilot Program for 510(k) “Quik” Review
FDA has launched a new pilot program for a “Quick Review“ of 510(k) of certain medical devices, by using the eSubmitter software to format the submission. The devices that qualify for this quick review, as shown on list below, are moderate risk devic…
CFDA Announced Major Changes to Chinese Medical Device Regulations in favor of Foreign Manufacturers
China Food and Drug Administration (CFDA) proposed major changes to medical device regulatory requirements by amending Order No. 650. The timeframe for the implementation of such changes has not been announced by CFDA yet, but foreign medical manufacturers are welcoming the new changes as they will address the major issues they are facing while registering […]
Japan PMDA Raising Medical Device Registration Fees
[vc_row][vc_column][vc_column_text]On April 1st, 2018, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has raised the registration fees for most medical devices . PMDA fee increase is ranging from 8% to 15% across nine device categories as …
FDA is aligning its QSR (21 CFR 820) with ISO 13485:2016
By 2020, the Food and Drug Administration (FDA) is planning to change its quality system requirements for medical device manufacturers stipulated in 21 CFR 820 by ISO 13485 :2016. This decision was taken as more and more regulators are looking toward adopting globally harmonized requirements that utilize regulations as well as standards, such as ISO […]
Unique Device Identification (UDI) Systems Expansion in Europe
The implementation of Unique Device Identification (UDI) systems in markets beyond the US is increasing, as the European Commission is planning to publish a guidance document on UDI under the MDR and IVDR in March 2018. It became clear that most markets will have a UDI system within five years . Although it will be […]
FDA New Pilot Program for Orphan Designation Requests
For Rare Disease Day, the FDA lunched a new pilot program to streamline orphan designation requests to make it easier for applicants and reviewers.
Japan cutting prices of new drugs and off-patent drugs
The Ministry of Health, Labor and Welfare is proposing a considerable cut down in the pricing of both off-patent drugs and expensive innovative treatments, and also set up an annual review of the drug prices.
CFDA New Clinical Data Requirements for Foreign medical devices
CFDA has proposed changes to Order 650 that would exempt additional types of Class II and III medical devices and IVDs from clinical trial requirements, and allow greater acceptance of clinical data from foreign countries in registration applications. The main changes to CFDA foreign clinical data acceptance criteria are as follows: Foreign clinical trials must […]
FDA New Guidance on De Novo Classification Process
On October 30, 2017 FDA published a new guidance that describes the process for the submission and review of a De Novo classification request for novel devices, that are automatically classified as Class III devices because they don’t have predicates. And allowing them to be down classified to Class I or Class II devices. A […]
2018 FDA Small-Business Medical Device User Fees
The US FDA has published new guidance explaining how companies should apply to qualify for small-business medical device user fees instead of much higher standard fees. Generally, companies must have no more than $100 million in sales to qualify for the FDA’s small business user fee program. The guidance includes separate requirements for US-based and […]
FDA NEWS: Priority Review for Generic on the Way
On June 19, 2017, the US Food and Drug Administration (FDA) released the draft guidance on the priority review of the applications for generics entitled” ANDAs: Pre-Submission Facility Correspondence Associated with Priority Submissions.” The Pre-Submission Facility Correspondence (PFC) process has been identified by the FDA as part of the performance goals and program enhancements for […]