A Medical Device Establishment Licence (MDEL) is a license issued to Class I medical device manufacturers, importers, or distributors of all device classes. In a recent guidance, Health Canada described how the Agency inspected the licensed medical device establishments, the inspection process and explained how inspectors should assess the compliance with the Food and Drugs Act and Medical Device Regulations.
- September 20, 2021 Medical Devices, Regulatory Affairs
- September 20, 2021 Medical Devices, Regulatory Affairs
The Medical Device Coordination Group (MDCG) has recently published a joint implementation and preparedness plan for the In Vitro Diagnostic medical devices Regulation 2017/745 (IVDR). It is well known that the IVDR is expected to come into force later in May 2022.
- September 20, 2021 Pharmaceuticals, Regulatory Affairs
Recently, the Director-general – NAFDAC announced the commencement of a Sensitization Campaign in Nigeria. Through this campaign, NAFDAC intends to inform, sensitize and educate the Nigerian citizens about the dangers of intake and use of bogus medicinal products surfacing the market.
- September 17, 2021 Medical Devices, Regulatory Affairs
The US FDA has published a guidance document that will help the industry and the Health Agency (HA) staff determine when a software change to a medical device requires a manufacturer to submit and obtain the FDA clearance of a new premarket notification (510(k)).
- September 17, 2021 Regulatory Labeling, Regulatory Software & Services
While creating compliant packaging, controlling the labeling flow and its implementation through artwork, supply chain and printing involves several internal and external stakeholders. Following up with all the teams to meet the time-critical mandates and deadlines can be challenging. Therefore, it is crucial to have a dedicated platform to handle the lifecycle changes of product labeling.
- September 16, 2021 Publishing & Submissions, Regulatory Software & Services
As many of the Health Authorities transitioned from paper documentation format to the eCTD format, it is time for organizations to define key measures to submit documents in the electronic format to remain compliant.
- September 16, 2021 Chemicals, Cosmetics Regulatory Services
Identification of the product category is perhaps the most crucial step to comply with the Regulatory requirements in the European market. The identification process can be quite challenging as many products fall under two (02) or more categories and are affected by different Regulatory frameworks. Such products are referred to as borderline products.
- September 15, 2021 Chemicals, Regulatory Affairs
The European Commission has updated the information requirements for chemicals registration under the EU REACH, intending to make the European Chemical Agency (ECHA) evaluation practices more transparent. The updates of the EU REACH annexes describe the information requirements for the companies that must be submitted during the chemical’s registration.
- September 15, 2021 Medical Devices, Regulatory Affairs
With the Brexit commencement, from Jan 1, 2021, there have been a lot of changes in the UK’s medical devices regulations, which the executive Regulatory Authority in the UK – MHRA has devised. Medical device manufacturers willing to enter the UK market especially, England, Scotland and Wales, will have to follow the applicable MHRA UK regulations.
- September 13, 2021 Pharmaceuticals, Regulatory Affairs
Health Authorities worldwide are initiating various programs to strengthen Adverse Drug Events (ADE) reporting of new prescribed medicines every day. An Adverse Drug Event (ADE) can be defined as any unfavorable and unintended sign, symptom, or disease associated with the use of a medicine. The safety and efficacy of new prescribed medicine is usually decided based on clinical trials.