This guidance covers ‘grandfathering’ and managing the lifecycle changes of medicinal products. This guidance will apply from 1 January 2021 in line with the Human Medicines Regulations.
The European Commission’s Medical Device Coordination Group (MDCG) released its much-anticipated guidance on the classification of in vitro diagnostics (IVDs).
If you are single product Device Company or single country multi-product company or a company with mostly low risk devices, externalizing with a partner on labeling...
With increasing concerns for patient safety and efficient supply chain management, a single, globally harmonized identification system for medical devices is needed.
The UK has left the EU, and the transition period after Brexit comes to an end this year. Stakeholders need to get ready for new rules from 1 January 2021.
As of 1 September 2020, all medical devices used by care providers must have a CE marking. Since mid-March, due to shortages caused by the corona pandemic.
In line with a reduction in restrictions, the inspectorate plans to resume an on-site UK risk-based GxP inspection programme starting in September.
Based on number of clinical studies conducted on devices in each country, below shows TOP 10 countries:
The European Commission has published an overview of the information that will be publicly available under EP and Council Regulation (EU) 2017/745 on medical devices.
With the new generation of medical devices, the software content in the devices is ever increasing.Software as a Medical Device (SaMD) brings new opportunities.
In the midst of the Covid-19 crisis, we have become painfully aware of the fragility of supply chains, health care, and other critical systems. Many leaders have announced.
On the 9th of July 2020 the European Commission has adopted a Communication to help national authorities, businesses and citizens prepare for the inevitable changes.
Due to the corona crisis the majority of the clinical trials conducted were put on hold. Since the Dutch Government currently gradually reduces the restrictive measures.
The European Commission’s Medical Device Coordination Group (MDCG) issued guidance explaining the process for transitioning CE certificates
The AEMPS extends the deadline until May 25, 2021 for the adequacy of the labeling and the instructions for use of medical devices as a consequence of the changes made by Brexit
The third edition of ISO 14971 was finally released in December 2019 and it replaces ISO 14971:2007. The risk management process itself remains largely unchanged.
It is know that Medical devices have long as well as highly regulated life cycles. Most manufacturers handle their devices in market properly with measures like routine and reactive quality, complaint handling and safety.
As the extended transition deadline 26 May 2021 is approaching, we should be ready for ensuring compliance with EU MDR. We have built a comprehensive plan...
There are several suggestions, recommendations from different health authorities for manufacturers to handle clinical trial aspects during this very challenging time of COVID.
The deadline for MDR is drawing near and for IVDR too there is not much time. In such a situation, manufacturers are busy in the process of collecting all sorts of data.
It has always been a difficult task to be compliant with the changing regulatory norms. When it comes to labeling, the criticality doubles as it becomes necessary to not only be compliant but to even...
Recently concluded RAPS- 2019 regulatory convergence at Philadelphia, PA was attended by a good number of representatives from pharma, biotech and device industries, from vendors offering...
This being the third time in a row, the United States Food and Drug Administration (USFDA) has extended the compliance date for the submission of Type III Drug Master Files (DMFs) in electronic...
All the biopharmaceutical companies must follow respective nation’s laws or regulations in order to develop, manufacture and sale their pharmaceutical products. Before any biopharmaceutical product...
PMS is a collection of processes and activities used to monitor the performance of a medical device. These activities are designed to generate information regarding use of the device to expediently...
Regulatory environment has become increasingly complex and making drug labeling a highly regulated and closely monitored activity. As some of you are aware, Health authorities are specific...