Regulations and Certifications for Medical Refrigerator from Major Economies
Medical refrigerators must comply with various regulations and certifications in different countries to ensure the safety and effectiveness of the products. The regulations cover various aspects like safety, performance, energy efficiency, and environmental impact. Here are respective regulations and certifications for pharmacy refrigerators in major economies in the world:
United States
a. The Food and Drug Administration (FDA) and its Centers for Devices and Radiological Health (CDRH) issue regulations and guidelines for medical refrigerators.
b. The Energy Star Program of the Environmental Protection Agency (EPA) sets standards for energy efficiency.
Europe
a. The European Union’s Medical Device Regulation (MDR) sets safety and performance standards for medical refrigerators.
b. The European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (CENELEC) create standards for medical refrigerators, including energy efficiency.
Canada
a. Health Canada regulates medical devices, including refrigerators, through the Medical Devices Regulations.
b. The Natural Resources Canada (NRCan) sets energy efficiency standards.
Japan
a. The Ministry of Health, Labour and Welfare (MHLW) regulates medical devices, including refrigerators, under the Pharmaceutical Affairs Law.
b. The Ministry of Economy, Trade and Industry (METI) sets energy efficiency standards.
Australia
a. The Therapeutic Goods Administration (TGA) sets standards for medical devices, including refrigerators.
b. The Energy Rating Labeling Act sets energy efficiency standards.
China
a. The China Food and Drug Administration (CFDA) oversees medical device regulation, including refrigerators.
b. The State Administration of Quality Supervision, Inspection and Quarantine (AQSIQ) sets energy efficiency standards.