Health Canada Continues to Actively Monitor Supply of Medical Devices
Health Canada’s role in managing medical device shortages in Canada. It explains how the government continuously tracks and updates the list of devices in short supply, ensuring transparency and quick responses to potential shortages. By working closely with manufacturers, importers, and healthcare providers, Health Canada aims to stabilize the supply chain through regulatory adjustments and proactive policies.
QCC x GMP: How does the Quality Control Certificate relate to ANVISA’s Good Manufacturing Practices?
The QCC (Quality Control Certificate) is indeed associated with ANVISA’s Good Manufacturing Practices (GMP), but they are not exactly the same thing. ANVISA’s GMP (Good Manufacturing Practices) is a regulatory requirement that certifies that health product companies, such as medicines and medical devices, follow safe and effective manufacturing practices. QCC certification is a type of quality control documentation that can be used to certify compliance with ANVISA’s GMP standards, but QCC itself is more of a type of control certification and does not replace the formal GMP authorization issued by ANVISA
ANVISA Intensifies Monitoring of Generic Drugs: New Requirements in Force
The National Health Surveillance Agency (Anvisa) recently announced a new package of regulatory measures aimed at strengthening the monitoring of generic drugs in Brazil. The aim is to ensure even greater safety and efficacy for these products, which are widely used by the population and represent a significant part of the national pharmaceutical market.
Clinical Trials for Drugs/Medicines in Brazil and the Clinical Trial Application process
In Brazil, clinical trials for drugs follow strict regulations, guaranteeing the safety of participants and the efficacy of the drugs being tested. The regulatory body responsible is the National Health Surveillance Agency (ANVISA), which establishes rules for conducting these studies.
The U.S FDA Announces Pilot Program for Medical Device Submission with Health Canada
Overview On January 2023, the FDA announced that it has partnered with Health Canada to launch a joint eSTAR pilot. The pilot will allow medical device manufacturers to submit a premarket notice submission to FDA and Health Canada simultaneously. Introduction The eSTAR is an interactive PDF form that helps guide applicants through the medical device […]
China’s CMDE Drafts Guidelines for the Registration of Implantable Medical Devices
On January 2023, the CMDE issued Chinese regulators issue regulations for enterprises’ management of medical device safety, plus draft guidelines for the registration and review of implantable medical device batteries.
China’s NMPA issues more Technical Guidelines for Bioequivalence Studies
China’s NMPA issues four technical guidelines for bioequivalence studies of specific varieties
China’s NMPA issues Notice on Technical Guidelines for Change Studies of Marketed Chemical Drugs
On November 8, 2022, the CDE issued a notice on “Questions and Answers for Dissolution Profile Studies ⟨Technical Guidelines for Pharmaceutical Change Studies of Marketed Chemical Drugs (Trial) ⟩”
China’s NMPA Announces Electronic versions of Drug & API Export Certificates (2022)
On December 2022, a new template Drug Export Sales Certificate has been launched, which conforms to the format recommended by the World Health Organization (WHO). Electronic certificates have the same effect as paper certificates.
China’s NMPA Announces Guidance for Good Operating Practices for Medical Devices
On November 2022, the NMPA issued the Announcement on “Appendix to Good Operating Practices for Medical Devices: quality Management of Enterprises Providing Transportation and Storage Services for Medical Devices”.
China’s NMPA Releases draft on the Regulations for the Implementation of the Drug Administration Law of the People’s Republic of China.
On May 9, 2022, The General Department of the National Medical Products Administration (NMPA) issued draft guidance on Regulations for the Implementation of the Drug Administration Law of the People’s Republic of China.
China’s NMPA: Local Agent in China for Foreign Pharmaceutical and Medical Device Companies
A Local Agent in China is legal representative of overseas pharmaceutical and medical devices companies required as per the NMPA regulations.