The medical devices undergo conformity assessment before they are included in the ARTG list to ensure that the devices comply with the essential principles required by the Therapeutic Goods Administration (TGA), Australia. Essential principles basically outline the safety and performance characteristics that any device should meet, so that it can be sold in Australia.
- July 13, 2021 Medical Devices
- July 13, 2021 Medical Devices
Mexico is considered as the second largest market for medical devices in Latin America. In Mexico, the Federal Commission for the Protection against Sanitary Risk (COFEPRIS) from the Secretariat of Health, regulates the Medical Device registrations and related services.
- July 8, 2021 Medical Devices, Regulatory Affairs
The Indian medical device industry has been recording significant growth and ranks in the top 20 markets for medical devices worldwide. It is estimated to reach USD 50 billion by 2025 from that of USD 10.36 billion in 2020.
- July 8, 2021 Regulatory Medical Writing
Regulatory writing discipline with its guidelines and regulations is considered complex. In addition, staying ahead of an ever-changing Regulatory environment for generic submissions and approvals is a tedious process.
- June 21, 2021 Medical Devices
The recent political changes between the Switzerland and European Union (EU) have significantly impacted the Medtech industry. With more than 1400 Medtech companies, the medical devices sector accounts for 3% of Switzerland’s GDP and provides employment for > 63,000 workforce. Switzerland exports medical devices worth > $5.6bn and the medical device imports from the EU account for $3bn.
- June 16, 2021 Pharmaceuticals, Regulatory Artwork Services
Pharmaceutical artwork is a highly regulated process, involving different regulations for multiple product portfolios. Despite the stringent regulations surrounding pharmaceutical packaging, artwork-related errors still exist and the potential for these errors is relatively high when the company relies solely on manual processes.
- June 10, 2021 Medical Devices
The Conformity Assessment Body (CAB) carries out the conformity assessment of various stakeholders of medical device supply chain system. The Conformity Assessment Body (CAB), Malaysia carries out extensive audits and evaluates all the applicable elements set by the Medical Device Authority (MDA), Malaysia and verifies the device conformity to the relevant standards.
- June 10, 2021 Medical Devices
The Conformity Assessment Body (CAB) plays a vital role in issuing various certifications and carrying out technical assessments required for successful registration and distribution of your medical devices and IVDs.
- June 3, 2021 Cosmetics Regulatory Services, Regulatory Affairs, Regulatory Labeling
Labeling and packaging are the two (2) important stages in the product lifecycle. They allow the consumers to know more about the product and understand its appropriate usage. From a manufacturer’s point of view, correct labeling helps in achieving compliance with the Regulatory bodies, defining the quality and providing statutory warnings to consumers.
- May 25, 2021 Regulatory Medical Writing
Profound research with poor documentation may not achieve Regulatory approvals. Documenting each section of ANDA demands attentive preparations by medical writers, else the entire development and marketing strategy will be derailed. Besides research protocols, the regulations, restrictions, and legalities that govern scientific and medical information play a vital role in ANDA submissions.