Comparison of Medical Device Regulations in India, Japan and South Korea

Increased health awareness, a growing middle class, and government health efforts are projected to propel India's medical equipment market forward in the next years. With the publication of the Medical Device Rules in 2017, Indian authorities revised the medical device regulatory process. The devices included in the link are currently regulated medical devices and in vitro diagnostic devices, as well as their classifications. CLA (Central Licensing Authority) is in charge of all import device licencing, as well as manufacturing, loan, and wholesale licences for Class C and Class D medical devices. Because of its complicated registration process and linguistic obstacles, Japan is regarded one of the most difficult markets for overseas medical device producers. The Pharmaceutical and Medical Device Agency, which works in tandem with the MHLW (Ministry of Health and Labour Welfare), is in charge of reviewing drug and medical device applications in Japan. The Pharmaceuticals and Medical Devices Act is a federal law that regulates the sale of pharmaceuticals and medical devices. The Pharmaceuticals and Medical Devices Act, also known as the Act on Securing Quality, Efficacy, and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics, lays out the current PMDA (Pharmaceuticals and Medical devices Agency) laws in Japan. South Korea is one of the largest health-care markets in the Asia-Pacific region. Medical Devices in South Korea are regulated by the Ministry of Food and Drug Safety (MFDS), formerly known as the Korea Food and Drug Administration (KFDA). Medical Devices in South Korea are regulated by the Ministry of Food and Drug Safety, formerly known as the Korea Food and Drug Administration. The Medical Device Act of 2015 governs current medical device laws in Korea. To access the South Korean Medical-Device-Market, you must first obtain marketing approval from the local Medical Device Authority, the Medical Device Information & Technology Centre, which is part of the Ministry of Food and Drug Safety. With the MFDS notification No. 2020-29, the South Korean Ministry of Food and Drug Safety launched UDI (Unique Device Identification System) operations in 2018. Article 20 of the Medical Device Act and Article 54-2 of the Medical Device Act Enforcement Regulations make UDI compliance mandatory.

Regulatory changes after the enforcement of the new Clinical Trials Act in Japan

Objective To describe changes in Japanese clinical trial regulations after the implementation of the Clinical Trials Act in April 2018. Methods First, how to apply multiple regulations after the enforcement of Clinical Trials Act was described. Second, the changes in the number of clinical trials in the National Cancer Center Hospital under each regulation were compared before and after the implementation of Clinical Trials Act. Third, new requirements imposed by Clinical Trials Act and their influences were discussed. Results In April 2018, Clinical Trials Act was enacted and academic clinical trials were classified into the following three categories: (i) investigator-initiated registration-directed trial under the Pharmaceuticals and Medical Devices Act; (ii) clinical trial under Clinical Trials Act; and (iii) clinical trial under the Ethical Guidelines. While 90% (205/227) of interventional studies were conducted under the Ethical Guidelines before the implementation of Clinical Trials Act in 2018, 46% (94/204) were subject to Clinical Trials Act in 2019 at the National Cancer Center Hospital. Under the Clinical Trials Act, investigators receive a scientific/ethical review by a certified review board (CRB). The identification of investigators in charge is mandated and they are required to submit the conflict of interest management plan to CRB. After the CRB review, the principal investigator must submit the trial plan to the government, and the content is uploaded to the newly established clinical trial registry site, the Japan Registry of Clinical Trials. Conclusions The enforcement of the new Clinical Trials Act was supposed to improve the reliability of academic clinical trials in Japan; however, the financial and administrative burden may reduce clinical trial activity in the years to come.

The Role and Experience of Sudan in Assisting To Develop and Implement National Drug Policies

The strategy of price liberalisation and privatisation had been implemented in Sudan over the last decade, and has had a positive result on government deficit. The investment law approved recently has good statements and rules on the above strategy in particular to pharmacy regulations. Under the pressure of the new privatisation policy, the government introduced radical changes in the pharmacy regulations. The 2001 Pharmacy and Poisons Act and its provisions established the Federal Pharmacy and Poison Board (FPPB). All the authorities of the implementation of Pharmacy and Poisons Act were given to this board. This article provides an overview of the impact of the pharmaceutical regulations on the quality of medicines on the Sudanese market from the perspective of the pharmacists working with drug importing companies. The information necessary to conduct the evaluation was collected from 30 pharmacists who are the owners or shareholders in medicines’ importing companies. The participants were selected randomly. 89% of respondents considered the medicines on the Sudanese market are generally of good quality. The design of the research itself may be considered inadequate with regard to selection process. However, the authors believe it provides enough evidence, and the current pharmaceutical regulations have some loopholes. The Pharmacy, Poisons, Cosmetics and Medical Devices Act-2001 and its regulation should be enforced. The overall set-up including the Act itself needs to be revised. The emerging crisis in pharmacy human resources requires significant additional effort to gather knowledge and dependable data that can inform reasonable, effective, and coordinated responses from government, industry, and professional associations. Furthermore research should be carried out to understand the scope, magnitude directions of the migratory flows, within and outside the country, as well as the characteristics and skills of the emigrated pharmacists.

„Do it yourself“ (DIY) Automated Insulin Delivery (AID) Systems: Stand der Dinge

Over the past few years, a group of dedicated people with an affinity for technology and type 1 diabetes has developed systems that enable automated insulin delivery (AID). Patients build these AID systems themselves (do it yourself; DIY). The quality of glucose control achieved with DIY AID systems is impressively good, but the effort for users in everyday life is considerable. So far, no results of clinical studies have been obtained that prove these individual experiences.Main obstacles for the use (also by more patients) are legal questions, because DIY AID systems do not represent approved medical devices. They must be regarded as “experimental” systems. As long as patients build and use these systems for themselves and do not endanger other people, they act at their own risk. Legal questions are more complex and more difficult to answer if, for example, a traffic accident occurs. A legal assessment (in particular of the medical situation) of such systems, initiated by the German Diabetes Society (DDG) (see DDG homepage), comes to the following key statements:– From the patient’s point of view, the assembly of a DIY AID system does not constitute a criminal offence. However, since the intended purpose of the devices is violated, there is no liability on the part of the manufacturers of the medical devices used for this purpose.– Patients who assemble DIY AID systems and “sell” them to other patients are liable to prosecution under the Medical Devices Act (MPG).– Doctors do not have to refer patients with type 1 diabetes to DIY AID systems.If a patient expresses interest in such a system or is already using it, the attending physician must inform the patient about the improper use of the medical devices used and about the associated risks. He should document this information accordingly.This overview presents the current status of this development from various points of view.