Arazy Group Blog | Medical Device Registration

Quality Marketing Medical Device in Singapore

Posted on January 16, 2012 by admin

Globally renowned Arazy Group is a reputed medical device consultant that assists medical equipment manufacturers in promoting their medical equipments in an international market. Our area of expertise lies in regulatory affairs and medical device registration services.

We provide global medical device registration that includes EU CE Mark, US FDA clearance, Argentina ANMAT approval, Brazil ANIVSA clearance, South Korea KFDA registration, Russia Gost – R, and lots more.

Singapore

• If you are looking to market your medical equipment in the market of Singapore then the regulatory body that looks after the medical devices is CDMR (Centre for Medical Device Regulation).

• CMDR ensures the quality, safety, and efficacy of medical devices in Singapore.

We are working in the field of medical devices consultancy for over 15 years and our team comprises of experts from varying field such as clinical researchers, quality assurance managers, medical experts, regulatory specialists, and scientists.

For any query or more information about Medical device Singapore, feel free to contact us.

Market Your Medical Devices in Philippines

Posted on January 16, 2012 by admin

Arazy Group is a global medical device consultant that assists medical equipment manufacturers in marketing their medical devices globally and in medical device registration. Our customized solution accommodates all stages of product life cycle.

Philippines

• If you are looking to market your medical devices in Philippines then it is a BFAD (Bureau of Food and Drug Administration), that regulates medical devices in Philippines.

• BFAD is under the department of Health and all the foreign medical devices have to undergo this registration procedure to promote their medical equipments in Philippines.

Arazy Group provides registration of medical devices in more than 53 countries that include South Korea KFDA registration, China – SFDA approval, Canada CMDCAS compliance, Russia GOST – R, Brazil ANIVSA clearance, US FDA clearance, EU CE Mark, Argentina – ANMAT approval, etc.

For any query or more information about medical device registration Philippines, browse the website.

Posted in Medical Device | Tagged CLINICAL TRIAL MANAGEMENT, CLINICAL TRIAL MANAGEMENT SYSTEM, CONTRACT RESEARCH ORGANISATION, FDA CONSULTANT, FDA CONSULTING, FDA ISO 13485, FDA QUALITY SYSTEM REGULATIONS, FOOD AND DRUG ADMINISTRATION MODERNIZATION ACT, Medical Device Registration, MEDICAL DEVICE REPORTING, Medical Devices in Philippines, Medical Lab Equipment, US MEDICAL DEVICE MARKET | Leave a comment

Promote Your Medical Devices in Malaysia

Posted on January 13, 2012 by admin

Arazy Group is a Vancouver based medical device consultant that assists medical equipment manufacturers in promoting their products in an international market. We provide registration of medical devices in more than 53 countries and our medical device safety compliance include electrical safety, product and material biocompatibility, medical device software validation, medical device sterilization, medical device labeling, and electromagnetic compatibility.

Malaysia

• There is a great potential for the medical equipments in the Malaysian market.

• If you are looking to market your medical equipment in Malaysia then it is the MDCD (Medical Device Control Division) under the ministry of health Malaysia that regulates medical devices and medical industry players in Malaysia.

Arazy Group works on the clinical and medical research that involve clinical development planning and trial design, clinical research administration, vigilance report, clinical evaluation through literature review, clinical study management, clinical literature review, and usability studies.

Kindly, browse the website for more information about medical devices Malaysia.

Posted in Medical Device Service | Tagged CLINICAL TRIAL MANAGEMENT, CLINICAL TRIAL MANAGEMENT SYSTEM, CONTRACT RESEARCH ORGANISATION, FDA CONSULTANT, FDA ISO 13485, FDA QUALITY SYSTEM REGULATIONS, FOOD AND DRUG ADMINISTRATION MODERNIZATION ACT, IEC 60601, medical device and equipment, medical device in malaysia, Medical Device Safety compliance, Medical devices, US MEDICAL DEVICE MARKET | Leave a comment

Efficient Medical Device Registration in Indonesia

Posted on January 13, 2012 by admin

Arazy Group is located in the Vancouver, BC, and helps medical equipment manufacturers in marketing their product internationally. We work for the medical device registration process that include US FDA clearance, EU CE Mark, Brazil ANIVSA clearance, Argentina ANMAT approval, Russia Gost – R, South Korea KFDA registration, medical registration in Indonesia, and lots more.

Indonesia

• There is a huge potential of medical device in an Indonesian market.

• It has a centralized healthcare system and ministry of health, purchases most of the hospital equipments and medical disposables.

Arazy Group is working in this field for over 15 years and had obtained clearance for medical devices and IVD’s in most European countries, North and South America, Australia, Africa, and various Asian markets. Our quality management system includes ISO 13485 Quality Management System, 21 CFR 820, FDA QSR, cGMP; Brazil GMP (B-Gmp) Modification, ANMAT GMP QMS System Implementation, CMDCAS – Canadian Conformity, and SOP – Clean room procedure.

Posted in Medical Device Consultants | Tagged CLINICAL TRIAL MANAGEMENT, CLINICAL TRIAL MANAGEMENT SYSTEM, CONTRACT RESEARCH ORGANISATION, FDA ISO 13485, FDA QUALITY SYSTEM REGULATIONS, FOOD AND DRUG ADMINISTRATION MODERNIZATION ACT, Medical Device, medical device in indonesia, Medical Device Registration, REGULATORY AFFAIRS CONSULTANTS, REGULATORY CONSULTANT, US MEDICAL DEVICE MARKET | Leave a comment

Promote Your Medical Device in Korea

Posted on January 12, 2012 by admin

Arazy Group is a global medical device consultant that helps medical equipment manufacturers in marketing their products in the global market. We provide registration of medical devices in Korea and our team comprises of quality assurance managers, clinical researchers, regulatory specialists, medical experts, and scientists. Our customized solution incorporated all the stages of medical device life cycle.

Medical Device Korea services include:

• Korea Food and Drug Administration (KFDA) regulate medical equipments under Korea’s Medical Device Act. The medical devices have to undergo KFDA registration and have to meet KGMP (Korean Goods Manufacturing Practice).

• Our global medical device registration include Argentina ANMAT approval, EU CE Mark, US FDA clearance, Brazil ANIVSA clearance, Russia Gost-R, Canada CMDCAS compliance, China SFDA approval, and South Korea KFDA registration.

Our medical device safety compliance include electrical safety, product and material biocompatibility, medical device sterilization, medical device software validation, medical device labeling, and electromagnetic compatibility.

Posted in Medical Device | Tagged Medical Device in Korea, Medical devices, Medical Devices Korea | Leave a comment

Medical Device Thailand FDA Regulatory Services

Posted on January 12, 2012 by admin

Arazy Group is a premier global medical device consultancy firm offering professional and efficient Thai FDA regulatory service for both domestic and imported medical devices in Thailand. Both the manufacturers and marketers can obtain authorized representation and a wide range of medical device service Thailand from medical device consultation experts.

Some of the best medical device regulatory services in Thailand offered by us include:

- Medical Device specific regulation strategy reports Medical Device Thailand Registration with Thai FDA

- Thai Representative and certification holder for Medical Device manufacturers

- Thai FDA Technical documents preparation

- Medical device registration in Thailand

- Arazy Group’s unique line of GlobaR – Global Regulatory Hub (Trade Mark) products.

For more details about our medical device service Thailand, contact us anytime!

Posted in Medical Device | Tagged CLINICAL TRIAL MANAGEMENT, CLINICAL TRIAL MANAGEMENT SYSTEM, FDA CONSULTING, FDA ISO 13485, FDA REGISTRATION, FDA REGISTRATION AND LISTING, FOOD AND DRUG ADMINISTRATION MODERNIZATION ACT, IEC 60601, Medical Device Consultants, medical device registration in Thailand, Medical Device Thailand, MEDICAL DEVICES REGULATORY, REGULATORY AFFAIRS CONSULTANTS, REGULATORY CONSULTANT, US MEDICAL DEVICE MARKET | Leave a comment

Significance of Medical Device Service in Thailand

Posted on January 11, 2012 by admin

In the field of medicine, medical devices play a crucial role in the diagnosis, monitoring, or treatment of diverse kinds of medical conditions. Such devices are designed to follow rigorous safety standards to ensure the safety of patients. These medical tools are very critical could disable the medical industry and could prove to be detrimental to a million lives. Thus, it is important that this equipment is properly taken care of in order to guarantee their consistency and functionality. Irrespective of you dealing with injuries or diseases, medical devices are becoming more and more common as far as medical diagnosis and treatment are concerned.

Medical device technologies are often used for a variety of medical purposes like surgery, diagnosing and therapy. Unlike pharmaceuticals, these technologies provide solutions through chemical, mechanical and technical means. In the medical industry, several hospitals are able to over and over again save lives and improve the quality of health for the average patient with the help of this and various other forms of modern technology.

Medical device companies in Thailand have a lot to offer in field of service equipment with the top of medical service companies which are consistently chosen by the clients for their diverse needs.

Posted in Medical Device | Tagged CLINICAL TRIAL MANAGEMENT, CLINICAL TRIAL MANAGEMENT SYSTEM, FDA ISO 13485, FDA QUALITY SYSTEM REGULATIONS, MEDICAL DEVICE DESIGN, Medical Device Service in Thailand, REGULATORY CONSULTANT | Leave a comment

Market Your Medical Devices in Hong Kong

Posted on January 11, 2012 by admin

Arazy Group is based in Vancouver region of British Columbia and help medical equipment manufacturers in promoting their products in an international market. We provide registration of medical devices in more than 53 countries and our quality management system (QMS) includes Quality System Audits, Brazil GMP (B-Gmp) Modification, ISO 13485 Quality Management Systems, ANMAT GMP QMS System Implementation, SOP – Clean room procedure, CMDCAS- Canadian Conformity, and 21 CFR 820, FDA QSR, cGMP.

Medical Devices in Hong Kong

• MDCO (Medical Device Control Office) under the Hong Kong department of health looks after the regulation of medical devices in Hong Kong.

• It was in 26th November 2004, the government of Hong Kong has launched MDACS (Medical Device Administrative Control System).

Arazy Group works on the medical device safety compliance that includes electrical safety, product and material biocompatibility, medical device sterilization, medical device software validation, and electromagnetic compatibility.

For any query or more information about medical devices, browse the website.

Posted in Medical Device | Tagged CLINICAL TRIAL MANAGEMENT, CLINICAL TRIAL MANAGEMENT SYSTEM, CONTRACT RESEARCH ORGANISATION, FDA CONSULTANT, FDA ISO 13485, FDA QUALITY SYSTEM REGULATIONS, FDA REGISTRATION, IEC 60601, medical device consultancy, MEDICAL DEVICE MANAGEMENT, Medical Device manufacturers, Medical Device Registration, Medical devices, Medical Devices in Hong Kong, medical equipment, REGULATORY CONSULTANT, US MEDICAL DEVICE MARKET | Leave a comment

Looking to market Medical Device in Taiwan

Posted on January 10, 2012 by admin

Arazy Group is a Vancouver based medical device consultant that assists medical equipment manufacturers in marketing their products in the global market. Arazy Group is working in this field for over 15 years and provide US FDA clearance, EU CE Mark, Brazil ANIVSA Clearance, Argentina ANMAT approval, Russia Gost- R, South Korea KFDA registration, and many more. Our team comprises of highly talented scientists, regulatory specialists, medical experts, quality assurance managers, and clinical researchers.

Marketing in Taiwan

• The registration process of medical device Taiwan is under Taiwan Department of Health (DOH) and is regulated by the BOPA (Bureau of Pharmaceutical Affairs).

• The devices have to undergo QSE (Quality System Documentation) registration under the Department of Health.

The clinical and medical research of Arazy Group involve clinical literature review, clinical development planning and trial design, clinical research administration, clinical study management, vigilance report, and usability studies.

For any query or further information about medical device Taiwan, browse the website.

Posted in Medical Device Service | Tagged CLINICAL TRIAL MANAGEMENT, CLINICAL TRIAL MANAGEMENT SYSTEM, CONTRACT RESEARCH ORGANISATION, FDA CONSULTANT, FDA CONSULTING, FDA ISO 13485, FDA QUALITY SYSTEM REGULATIONS, FOOD AND DRUG ADMINISTRATION MODERNIZATION ACT, ISO 1348, Medical Device, medical device and equipment, Medical Device in Taiwan, MEDICAL DEVICE MANAGEMENT, medical equipment, Medical Lab Equipment, REGULATORY AFFAIRS CONSULTANTS, REGULATORY CONSULTANT, US MEDICAL DEVICE MARKET | Leave a comment

Looking To Market Medical Devices in India!

Posted on January 10, 2012 by admin

Arazy Group is a medical device consultant, located in the Vancouver region of British Columbia. We are specialized in marketing medical technology in an international market and our customized solutions are available for all stages of medical device lifecycle.

India

We provide registration of medical devices in more than 53 countries and had obtained clearance of medical devices in Australia, Africa, America, Asian markets, and most European nations.

• If you are looking to market your medical device in India, then it is a CDSCO under the Ministry of Health and Family Welfare that look after the medical devices, drugs, and cosmetics in India.

• The CDSCO (Central Drug Standard Control Organization) is responsible for the regulation of medical devices and drugs in India.

We are working in this field for over 15 years and utilize verification, validation, regulation process for the diverse portfolio of medical devices.

For any query or more information about medical devices in India, browse the website.

Posted in Medical Device | Tagged CLINICAL TRIAL MANAGEMENT, CLINICAL TRIAL MANAGEMENT SYSTEM, CONTRACT RESEARCH ORGANISATION, FDA CONSULTANT, FDA CONSULTING, FDA ISO 13485, FDA QUALITY SYSTEM REGULATIONS, medical device and equipment, Medical Device Consultants, MEDICAL DEVICE CONSULTING, MEDICAL DEVICE CONSULTING ORGANIZATION, MEDICAL DEVICE MANAGEMENT, Medical Device Registration, Medical Devices in India, MEDICAL DEVICES REGULATORY, REGULATORY AFFAIRS CONSULTANTS, REGULATORY CONSULTANT, US MEDICAL DEVICE MARKET | Leave a comment

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