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  • [information] India, Japan and South Korea and other 9 countries and regions, medical equipment registration guide
  • 2016/11/12 Read the number:[15426]
  • Guide for registration of medical devices in 9 countries and regions, such as India, Japan and South Korea
    The rapid development of the global medical device industry has brought a new challenge for the quality management and effective supervision of medical devices. Through the limited supervision and management of medical equipment, to maximize the control of medical equipment, the potential risks and to ensure the safety and effectiveness of medical equipment, is the world's very concerned about the problem. For this, each country also made according to their own national conditions a variety of access rules. In this, the author selects some countries, the registration and regulatory requirements for medical devices are simply presented, for reference only.
    Japan's pharmaceutical and medical devices are managed by the health, labor and Welfare Department (responsible for the Japanese Ministry of health). Japan's MITI, Ministry and medical equipment industry association, in their respective functions within the scope of mutual cooperation, and jointly promote the development of medical devices in japan.
    In Japan, medicines, medical equipment management laws and regulations are divided into three categories: by the Japanese parliament approved the law said through; by the Japanese government cabinet approved by the said decree or edict, by health and welfare minister approved said notice or order.
    Responsible for the management and supervision of medical devices by the Ministry of health and welfare. According to the Ministry of health pharmacy method for management of medical devices, administrative management in Medicine Bureau under the medical class, and in conjunction with the supervision and guidance of class with the quality system inspection. At the same time, the Department of medical products in the National Institutes of health, the medical equipment for technical review and related research.
    Regulators: the Japanese Ministry of health
    Japan will be divided into 4 types of medical equipment. One is the general medical equipment, believes that even if the occurrence of adverse events, but also a very low risk to human products, such as a scalpel, in vitro diagnostic equipment without approval; two for the control of medical equipment, that even if the occurrence of adverse events, risk is relatively low on the human body products, such as electronic endoscope mirror, digestive organs with catheter etc..
    In the second class, used without approval standards determined by the Minister of labour and welfare minister, by prior private third party labor and welfare minister to accept the registration of certification bodies (13 existing institutions) and the standard compliance certification system; three is highly regulated medical equipment, in adverse during the event, the relatively high risks to human products. Such as artificial bone, artificial dialyzer, respirator, heart blood vessel with balloon catheter.
    To be approved by the Minister of Health (PMDA review); 4 for highly regulated medical devices, to patients with invasive and adverse events in case may directly lead to dangerous products, such as pacemakers, artificial heart bracket, etc.. To be approved by the Minister of Health (PMDA review).
    Laws and regulations can be divided into three categories: laws and decrees / laws, order / notice.
    In Singapore, medical device products are divided into A, B, C, D and other 4 categories. A medical instrument for low risk products, such as medical dilator / spatula; B for low risk products, such as hypodermic needle / suction equipment; C for high risk products, such as lung ventilators / plate; D for high risk products, such as heart valve / implantable defibrillator.
    Regulatory agencies: the Health Sciences Authority
    In Singapore to operate medical device products, dealers are required by the medical device information and communication systems (MEDICS) online submission of the application. All dealers must be registered in the accounting and corporate regulatory accounts, and use customer registration and identification services (CRIS) account to log on to the MEDICS system. Once approved, authorized employees or service providers can use the government to deal with the common password SingPass or Health Bureau authentication code PIN HSA landing MEDICS system.
    Class a medical device registration application is divided into 4 steps, that is, to submit applications, screening, assessment, the competent authorities to make a decision.
    B, C, D products, including the application materials, referring to the ASEAN countries to submit information template (CSDT) to prepare the English application, the relevant certificates, reports and labels copy. At the same time, should also be submitted to a good circulation of standard certificate (GDPMDS) or medical device quality management system ISO 13485 certificate. The applicant company shall designate a principal contact person to be responsible for all issues relating to the application, including supplementary materials as required. The applicant shall comply with all the terms and conditions of the registration.
    If there is a specific problem or not determine whether the application documents are in line with the standards, can be submitted before the consultation. In addition, the registered person may submit the application of the medical device product to the Singapore medical equipment registration centre (SMDR) for the decision of the competent authority to assess whether or not to register the product.
    All dealers must be registered in the accounting and corporate regulatory accounts, and landing MEDICS system.
    In Australia, medical equipment refers to the body of the apparatus, equipment, equipment, materials or other articles (required for use alone or in combination and appropriate application software), in order to realize the purpose of alleviating disease diagnosis, prevention, care, treatment or.
    The production of medical devices in Australia, must through the conformity assessment, inspection of medical compliance in related markets (such as Australia, Europe and the United States) requirements for listing standards; sales of medical devices must apply to the customs system in electronic devices (DEAL) in the online application, complete the registration in Australia at the treatments (ARTG) product registration. ARTG is a registration system for the registration of treatment products, requiring dealers to produce and operate (including imports and exports) of medical device products.
    Regulatory agencies: the Australian Therapeutic Goods Administration (TGA)
    In the production of medical products in Australia, domestic producers are required to obtain Therapeutic Goods Administration issued qualification certificates; overseas manufacturers will need to have the agreement certificate / CE certification in Europe and Australia's declaration of conformity. Manufacturers will be the appropriate qualification certificate to the dealer, and then by the dealer through the DEAL system to submit as a manufacturer qualification certificate.
    TGA after the review will be applied to the manufacturer's qualification certificate. Dealers through the DEAL system to submit a medical device application and pay a certain fee, TGA will add the medical device to the ARTG record. Dealers must pay an annual fee, TGA need to monitor the product after the listing.
    Overseas manufacturers need to have the agreement certificate / CE certification in Europe and Australia's declaration of conformity.
    Taiwan, China
    In Taiwan, the food and Drug Administration "(TFDA) is responsible for the medical devices registration approval;" compliance Health Bureau "drug evaluation center of new drugs and medical devices to assess and provide consulting services to related parties.
    Taiwan medical device regulatory framework consists of product grade, quality system and GMP compliance production, registration, label control, commercial advertising management, clinical investigation control, adverse reaction reporting and sales and distribution control. Medical devices can be classified into 17 categories according to their functions, objectives, methods of use and operating principles. In order to facilitate supervision, but also according to its degree of risk of the human body is divided into three levels: one for the low risk, two for the risk, the three level for the high risk.
    Taiwan food and drug administration"
    The application level of instruments to be submitted a copy of the application form, medicines and medical equipment production license / distributors, does not need the quality system documents, according to the different levels of medical risk monitoring standard of different registration; apply for two instruments required quality system certification documents and TFDA product registration certificate or third party certificate to apply for three; need equipment quality certification documents and TFDA product registration and clinical data. Application for two or three medical device licenses are required medical device GMP certificate, pre listing review and technical review, medical device license approval or update.
    According to the degree of risk is divided into three levels: the first level is low risk, the two level of risk, the three level is high risk.
    In India, medical devices are devices that can be used for the diagnosis, treatment, treatment, relief or prevention of disorders or diseases of the human body or animal. To submit an application to the relevant departments in the production and operation of medical equipment, the application should be made clear that the purpose of the application, the authorized person should be signed and sealed, and attached to the name and position.
    Regulatory agencies: India central drug standards control agency
    Submit application materials including cover letter, quality authorization book, wholesale license, free sale certificate, ISO13485:2003 certificate, complete guarantee certificate, the European standard design inspection certificate, declaration of conformity and inspection / audit report. Application for the issuance of a license to be issued by the manufacturer or authorized agent of India to submit the "Form 40" form to the license issuing authority. The manufacturer's authorization for an agent in India shall be verified by the India district judge or a lawyer with the same authority as the original state.
    Submitted to the "Form 40" form at the same time should pay the registration fee of 1500 US dollars, the venue for the production of the export to the use of drugs in India. Applicants are required to pay $5000 for the inspection of the production site. The registration certificate is valid for three years from the date of issue. If the registration certificate is not obtained at the specified time, the applicant may appeal to the central government.
    A lawyer authorized by a domestic agent to be verified by a local judge or a lawyer with the same authority as the original state shall be in writing.
    In Malaysia, medical equipment is used by manufacturers use alone or in combination on the body's instruments, equipment, instruments, machines, devices, implants, or in vitro reagent calibrator, software, material or other similar or related items, in order to prevent, diagnosis, treatment, monitoring or alleviation of disease such as one or more a purpose. According to the human body caused by the degree of risk, product technical design and production, medical equipment can be divided into a (low risk), B level (low risk), C level (high risk) and D level (high risk).
    Regulatory agency: Malaysia medical device administration
    In Malaysia, the medical device authority determines whether the product is classified as a medical device and a medical device, and is commissioned to assess the conformity assessment body.
    Malaysia MeDC@St medical device registration, MeDC@St is a registered license, medical device registration and export license of network application system, which is a centralized system, applicants only need to create an account can apply for registration of medical devices registration license, or export license. The country will be divided into 4 categories of medical equipment products: a class a medical device is the lowest risk; B class, C class center; D products, the highest risk.
    The applicant can only create an account to apply for registration of a license, medical device registration or export license.
    The Republic of Korea
    South Korea food and Drug Administration Department of medical equipment and radiation health department is responsible for the inspection and quality assurance of medical equipment, the development of radiation standards, management of radiation safety control projects and medical equipment research work.
    Regulatory agencies: South Korea food and Drug Administration (KFDA)
    In South Korea, the South Korean food and Drug Administration on medical devices classification regulation. KFDA requires a class of equipment before the listing notice, the two or three categories of equipment to implement the approval before listing.
    KFDA only issue licenses to local companies. Two or three types of equipment applications need to provide for the assessment of technical documents (registration materials), and the local test of the imported samples, sample imports need to be approved by KFDA. South Korea provides importers should ensure that imported products meet the requirements of the quality management system, and to get the license of KFDA authorized institutions.
    After KFDA approval, the two or three types of equipment imported from each batch shall be tested locally before entering the market. For clinical trials, clinical trials have been carried out in foreign countries in accordance with good drug clinical test specification (GCP) standards, which may be exempted from local clinical trials.
    The importer shall ensure that imported products meet the requirements of the quality management system and shall be licensed by the KFDA authority.
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Office Add: No. 9, Middle Renmin Road, Yancheng City, Jiangsu Province, China  Factory Add: No.8 Weiyi Rd. Qingyang Industrial Park, Tinghu District, Yancheng City, Jiangsu Province, China