ANVISA -RDC 305/2019- Regulation for Custom-Made Medical Devices
On October 2019, Anvisa published its formal regulations for custom-made medical devices “RDC 305/2019. “
ANVISA Regulatory Priorities for Medical Devices in 2020
Anvisa announces its regulatory priorities for Medical Devices in 2020.
China’s CMDE announces new regulations on the supervision and adminstration of customized medical devices for clinical trials.
China’s CMDE Announces new Regulations on the Supervision AND Administration of Customized Medical Devices for Clinical Trials
Drug Master File (DMF) in China
The new system set up by the NMPA allows manufacturers to file the DMF directly, thereby reducing the approval time and respective cost involved.
China Expediting the Review and Approval of Drugs to Treat Life Threatening Diseases
Chinese health authority published a list with 48 orphan drugs that qualify for an expedite review process of their registration application. The 48 drugs are used for the treatment or prevention of rare and life-threatening diseases, and have alread…
FDA Waiving the Informed Consent for Minimal Risk Clinical Studies
On November 2018, FDA proposed a new rule that will allow investigators to request a waiver of the informed consent from the IRB for minimal risk clinical studies.
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 Program for the Review of Innovative Medical Devices in China
The Chinese National Medical Products Administration (NMPA) has published revised requirements for its innovative medical device review program that will take effect December 1, 2018. The new NMPA policy, Order 83 [2018] includes three major changes: Applications for Innovative Devices must be submitted to NMPA within five years of patent publications; Application review timeframes will […]
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 […]