Regulatory Compliance

 

All of the products that we source are done so through licensed wholesalers, pharmacies, and clinics that are in good standing under the licensing requirements of their respective agency. The licensing and quality control of the products we distribute are regulated by the agencies below.  All our vendors go through a comprehensive qualification process that requires them to strictly document all of their Standard Operating Procedures (SOP's) in order to make sure they are compliant with the regulatory agency in their jurisdiction.

 

FDA

USA Food and Drug Administration.  The FDA's primary responsibility is to protect the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, the nation’s food supply, cosmetics, and products that emit radiation.The US-FDA is the USA federal regulator for food, medicines, medical devices, and cosmetics.

Medical Devices

From simple items like tongue depressors, to complex technologies such as heart pacemakers.  Premarket approval of new devices,  manufacturing and performance standards, tracking reports of device malfunctioning and serious adverse reactions

 

Health Canada

Health Canada is the Canadian federal regulator for therapeutic products. Health Canada is the federal department responsible for helping the people of Canada maintain and improve their health. Health Canada is committed to improving the lives of all of Canada 's people and to making this country's population among the healthiest in the world as measured by longevity, lifestyle and effective use of the public health care system.

Medical Device

The term Medical Devices, as defined in the Food and Drugs Act, covers a wide range of health or medical instruments used in the treatment, mitigation, diagnosis or prevention of a disease or abnormal physical condition. The term "medical device" covers a wide range of products used in the treatment, mitigation, diagnosis or prevention of a disease or abnormal physical condition. Some examples include pacemakers, artificial heart valves, hip implants, synthetic skin, medical laboratory diagnostic instruments, test kits for diagnosis and contraceptive devices.

EMA

The European Medicines Agency (EMA) is a European Union agency for the evaluation of medicinal products and medical devices. From 1995 to 2004, the European Medicines Agency was known as European Agency for the Evaluation of Medicinal Products.

Roughly parallel to the U.S. Food and Drug Administration (FDA), but without FDA-style centralization, the European Medicines Agency was set up in 1995 with funding from the European Union and the pharmaceutical industry, as well as indirect subsidy from member states, in an attempt to harmonize (but not replace) the work of existing national medicine regulatory bodies.

MHRA

The Medicines and Healthcare products Regulatory Agency (MHRA) is the UK regulatory arm responsible for the regulation of medicines and medical devices and equipment used in healthcare, and the investigation of harmful incidents. The MHRA also looks after blood and blood products, working with UK blood services, healthcare providers, and other relevant organisations to improve blood quality and safety.

Medical Devices

The term 'medical device' covers all products, except medicines, used in healthcare for the diagnosis, prevention, monitoring or treatment of illness or disability. The range of products is very wide: it includes contact lenses and condoms; heart valves and hospital beds; resuscitators and radiotherapy machines; surgical instruments and syringes; wheelchairs and walking frames or other assistive technology products - many thousands of items used each and every day by healthcare providers and patients.

PMDA

Pharmaceuticals and Medical Device Agency of Japan.  The PMDA is the Japanese medical device regulator and is part of the Ministry of Health, Labour and Welfare.  PDMA conducts and Medical Device Reviews specifically:
Scientific reviews of pharmaceuticals and medical devices for marketing authorization based on the Pharmaceutical Affairs Law of Japan
Consultation (Planning and implementation of clinical trials and preparation of NDA dossiers, etc.)
GCP / GLP / GPSP inspections and conformity audit on dossiers submitted as initial application, re-examination and re-evaluation application
GMP / QMS inspections on manufacturing sites, processes and quality management system of pharmaceuticals and medical devices
Confirmation of re-examination and re-evaluations based on the Pharmaceutical Affairs Law

TGA

Australian Therapeutic Goods Administration (TGA).  The Therapeutic Goods Administration (TGA) is part of the Australian Government Department of Health and Ageing, and is responsible for regulating therapeutic goods including medicines, medical devices, blood and blood products.  This includes goods that we rely on every day, such as sunscreens, through to goods used to treat serious conditions, for example prescription medicines, vaccines, blood products and implants.  Essentially, any product for which therapeutic claims are made must be listed, registered or included in the Australian Register of Therapeutic Goods (ARTG) before it can be supplied in Australia. 
The TGA evaluates therapeutic goods before they are marketed and monitors products once they are on the market, it also assesses the suitability of medicines and medical devices for export from Australia.

The TGA also regulates manufacturers of therapeutic goods to ensure they meet acceptable standards of manufacturing quality. It has a team of manufacturing inspectors that audit manufacturing facilities around the world to ensure that products supplied in Australia are of high quality. 

Global Harmonization Task Force (GHTF)

The GHTF is an association of key regulators working to develop ways to develop a common approach to the regulation of medical devices. The GHTF provides guidance to other regulators about best practice in all areas of medical device regulation.

Asian Harmonisation Working Party

The AHWP is an association of Asian countries that are working to harmonise medical device regulation in coordination with the Global Harmonisation Task Force, the Asia Pacific Economic Community and other international organisations. AHWP is a liaison partner of the GHTF.

Global Medical Device Nomenclature (GMDN) Agency

The GMDN Agency maintains the database of GMDN codes used to provide identifiers for types of medical devices.

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