In the People’s Republic of China, the manufacturing, marketing, distribution, and sale of medical devices, are mainly regulated by the Regulations on Supervision and Administration of Medical Devices. These laws were developed by the State Council and are governed by the National Medical Products Administration (NMPA) which is the governmental authority primarily responsible for the supervision and administration of medical devices in the Peoples Republic of China.
Pharmaceutical Affairs Law (PAL) covers regulations on pharmaceuticals, medical devices and cosmetics in Japan. This includes the Minister of Health, Labour and Welfare which has the authority to give a marketing approval, to issue a license for marketing authorization holder and to issue a manufacturer license.
The Portuguese Regulatory Authority (RA) is INFARMED (Autoridade Nacional do Medicamento e Produtos de Saúde / National Authority of Medicines and Health Products), an agency within the Portuguese Ministry of Health, which evaluates, authorizes, regulates and supervises the market, regardless of the origin of the devices, guaranteeing the protection of public health.
A 2017 World Health Organization (WHO) report found that 40% of countries in the WHO-defined African region have no regulations for medical devices, 32% have some regulations, and the remaining 28% have no available data. That's very alarming for developing countries globally.
Design controls are used to ensure that medical devices meet user needs, intended uses, and specified requirements. These controls usually apply to the design of the product, as well as associated manufacturing processes. Though they aren’t required for all medical devices, most medium and high risk devices are normally associated. In the United States, the FDA requires design controls for all class II and class III medical devices, mandated by ISO 13485:2016. For products marketed in other countries, similar design controls requirements exist, although terminology may differ. Sources say that the new EU MDR requires a quality system that encompasses many FDA equivalents, and countries like Canada require quality systems to be ISO 13485:2016 certified. So in a sense, ISO 13485:2016 can be seen as a global standard. China is another country with a comprehensive design control system, with theirs being regulated by the CFDA. The purpose of design controls is to detail the steps you will take in order to prove a medical device meets a valid user need, that it is safe, and that the medical device and its production process meet regulatory requirements. With that being said, you would assume that other countries around the globe outside of the US would have similar regulations to their medical devices.
China is one country with a comprehensive design control system regulated by the Chinese Food an Drug Administration(CFDA). since 2013 the CFDA has been revamping their medical device controls. in march of 2015 the CFDA "revised [their] Good Manufacturing Practice for Medical Devices compris[ing] [of] 84 articles in 13 chapters, which requires medical device manufacturers to set up and improve the quality management system in accordance with this GMP, and specifies relevant requirements on organization and personnel, premises and facilities, equipment, document management, design and development, procurement, production management, quality control, sales and after-sales services, control of nonconforming products, adverse event monitoring, analysis and improvement etc."
http://boston-biomedical.com/changes-to-medical-device-regulations-in-china/
http://eng.sfda.gov.cn/WS03/CL0770/98157.html
http://www.medicaldesignandoutsourcing.com/china-new-medical-device-classification-catalog-need-know/
The CFDA requirements are a good example of the enforcement of design controls outside of the US. It would be assumed that other countries around the globe have similar processes to ensure that medical devices are safe, effective, and meet regulatory requirements. Canada requires quality systems that are ISO 13485:2016 certified, and the EU requires quality systems that encompass many FDA equivalents. Though requirements may vary from country to country, this shows that there are many similarities for regulations among medical devices.
@llefevre you did a good job highlighting regulations on medical devices in different areas across the globe. What stands out most to me is the information you provided from the World Health Organization on countries in African regions. With only 32% having some form of regulation on medical devices, this is quite alarming. Do you think these regions will adapt similar regulations and authorities in the coming years?
You described the necessary use of Design Controls in other countries very well. Design controls are a series of processes that ensure a device is safe, it works and meets the needs of the market. In the US the FDA and ISO code regulation meet the needs of Class II and III medical devices. While in the EU the MDR regulates their classes of medical devices. It closes follows the FDA 21 CFR Part 820 and ISO 13485:2016. China on the other hand utilizing the CFDA for its control design system. In each country, medical devices that are released to the market must meet valid user needs, safety and efficacy, and meet regulatory requirements.
China is one country with a comprehensive design control system regulated by the Chinese Food an Drug Administration(CFDA). since 2013 the CFDA has been revamping their medical device controls. in march of 2015 the CFDA "revised [their] Good Manufacturing Practice for Medical Devices compris[ing] [of] 84 articles in 13 chapters, which requires medical device manufacturers to set up and improve the quality management system in accordance with this GMP, and specifies relevant requirements on organization and personnel, premises and facilities, equipment, document management, design and development, procurement, production management, quality control, sales and after-sales services, control of nonconforming products, adverse event monitoring, analysis and improvement etc."
http://boston-biomedical.com/changes-to-medical-device-regulations-in-china/
http://eng.sfda.gov.cn/WS03/CL0770/98157.html
http://www.medicaldesignandoutsourcing.com/china-new-medical-device-classification-catalog-need-know/
This is really interesting! Both your summary of their system as well as the information that can be found on the websites. I like that their GMP has such a large part of their design control system because often that s an area that gets left out. As we learned in our lab class, sometimes people just get too comfortable in the lab.
In many countries the design control standards are different. While in the US FDA follows ISO code regulations. On the other hand, there are different standards settled by other countries. Though there is a huge geographic and immune difference, most third-world countries follow blindly the standards set by first-world countries. Consequently, it brings harm to their people. In each country, medical devices that are released to the market must meet valid user needs, safety, and efficacy, and meet regulatory requirements.
I have looked into the regulations in Mexico since they are the second-largest medical device market in Latin America. Like the US, the medical devices are classified into three classes with low risk being Class I. There are two approval processes:
Equivalency Review Process: This option is if the medical device has been already approved in the US, Canada, or Japan. If the device was approved in Canada, the timeline of the process is about the same as the other option, however, less paperwork is needed. If the device was approved in Japan, this process can be rather fast.
Standard Review Process: The regular, time consuming process if the needs for the previous review process is not met. Choosing this process allows the medical device to undergo a third party review, which allows companies to pre-approve the application to speed up the process. The third party review is accompanied with a fee.
COFEPRIS Medical Device and IVD Registration and Approval in Mexico (emergobyul.com)
The Turkish Medicines and Medical Devices Agency is in charge of design control in Turkey. It adheres to ISO 13485 and ISO 9001 standards. Medical devices in Turkey must be CE-marked and registered in the Turkish Ministry's Online Database of Turkish Drug and Medical Device National Databank. CE marking is a manufacturer's assurance that the product complies with the essential requirements of applicable European medical device standards. Documentation must, as one might expect, be in Turkish. Finally, a local and authorized representative for the medical equipment and product must be present during the device control procedure.
Design control in the United States is governed by the FDA. They oversee medical devices, drug administration, and the clinical trial phases. From my research, I conclude that Design Control depends on the country's global stance; most modern countries like Canada, the UK, and Japan have relatively similar design controls while third world countries like Africa vary from poorly regulated to non-existing Design Control. The European Union has a Commission that overlooks every step of any medical device that is approved by the board.
Regulation of medical devices is different across the world. Some places have very complex requirements while others have none at all. In the U.S., we have established Design Controls. Design controls designate the application of a formal methodology to the conduct of product development activities. It is often mandatory to implement such practices when designing and developing products. In China, they have a comprehensive design control system that is regulated by the Chinese Food and Drug Administration. This system requires medical device manufacturers to set up and improve the quality management system in accordance with GMP and specifies relevant requirements. In Africa, approximately 9% of their 46 sub-Saharan countries have policies in place, National Medicines Regulatory Authorities. The other countries only have minimal regulatory policies while the rest of the country (approximately 30%) has no design control regulations whatsoever.
New medical devices offer fresh opportunities for your company to improve health outcomes, push the boundaries of medical innovation, and grow your business. But medical devices also carry varying levels of risk that must be carefully managed. As the product manufacturer, it’s your job to ensure your device is both effective and safe for users whose health may be on the line. For all but the lowest-risk medical devices, the Food and Drug Administration requires proof that you have done just that. The first step in meeting the FDA’s requirements is to develop your medical device under Design Controls. Design Controls, which are mandated by the FDA, represent a formalized approach to the development of Class II and Class III medical devices. This process includes many layers of required documentation that show the FDA exactly how you have provided for the safety and efficacy of your new device. These were created back in 1996. They use the 21 CFR Part 820.20 and later adopted the ISO 13485:2016. There are 9 parts that must be included: Planning, Input, Output, Review, Verification, Validation, Transfer, Design Changes, and Design History File. Depending on the company, they may put more than one part on each page. As long as all parts are accounted for, you will not encounter any issues. In Japan, pharmaceuticals and medical devices are regulated by the Pharmaceutical and Medical Device Agency (PMDA) and the Ministry of Health, Labor, and Welfare (MHLW). The PMDA is an independent agency that works together with the MHLW to assess the safety and effectiveness of medical products. Japan uses a risk-based classification system to categorize medical devices into four classes based on the associated. In November 2014, the Japanese pharmaceutical and medical device market underwent significant changes due to the replacement of the Japanese Pharmaceutical Affairs Law (JPAL) with the new Pharmaceutical and Medical Device Act (PMD Act). The PMD Act affects major areas of medical device regulations, including quality management system compliance, device registration, the regulation of medical software, and third-party certifications. In order to market medical devices in Japan, manufacturers must be compliant with the current PMD Act. The Japanese medical device market is one of the largest in the world, behind Europe and the United States. That said, despite being a very technologically developed country that is home to many large, multinational medical device corporations, a high percentage of the medical devices marketed and sold in Japan come from foreign manufacturers. Due to a large aging population, the demand for medical devices in Japan is massive. As a result, despite its challenging regulatory processes for registering medical devices, Japan is a very lucrative market for foreign device companies. In August, 2016, Japan’s Ministry of Health, Labor and Welfare (MHLW) has published an administrative notice on how some of the new ISO 13485:2016 quality system standard for medical devices will be incorporated into the country’s own QMS requirements. The notice focuses on the relationship between the updated ISO standard and Chapter 2 of the MHLW Ministerial Ordinance No. 169 covering medical device quality system compliance in Japan. Ordinance No. 169 entails some quality system requirements specific to the Japanese market. Japan has largely embraced ISO 13485 as the basis for their QMS requirements. The PMD Act introduced a more harmonized approach to quality regulations for medical device manufacturers. However, Ministerial Ordinance #169 contains additional QMS requirements you must meet to be in full compliance. Manufacturers with ISO 13485 certification will find compliance with Ordinance #169 is fairly straightforward by adjusting some gaps between ISO 13485 and Ordinance #169. According to the PMD Act, manufacturing facilities are subject to a QMS conformity assessment as part of the Japanese registration process. QMS conformity assessments are conducted by the Pharmaceuticals and Medical Devices Agency (PMDA) or a Registered Certification Body (RCB). Foreign manufacturers that have chosen the Foreign Special Approval System route and hold pre-market approvals or certifications will undergo QMS conformity assessments. Foreign manufacturers must appoint a Designated Marketing Authorization Holder (D-MAH) to represent them in Japan. Upon successful completion of a QMS conformity assessment, a MAH or manufacturer is issued a Certificate of QMS Conformance by either the PMDA or RCB. Certificates of conformance are valid for five years and include the registered product name, product group, and manufacturing facility. Under the PMD Act, future conformity assessments focus on devices from the same product group registered with the PMDA or RCB, rather than the manufacturing facility.
Design controls are used in many other countries, while at the same time there are countries that have little to no regulation on devices at all. Two countries that I would highlight are China and the Central African Republic. I chose these two countries because they couldn't be anymore the opposite of one another when it comes to the use of design controls and medical device regulations. In the Central African Republic, there is no formal regulatory approval process and no use of design controls or regulatory laws in the manufacturing of medical devices. In fact, this is the case for most of the countries in Africa. On the complete opposite end of the spectrum, China has an extremely extensive and comprehensive design control regulatory system in place. Manufacturing relies on design controls. Japan is another example of a country that has extensively regulated manufacturing. Both of these countries have embraced ISO 13485 and it is the basis of their Quality Management compliance for manufacturing.
Countries such as Europe, Canada, Japan, Malaysia, Singapore and Australia have Design Controls and require ISO 13485 certification. European companies who are active in the EU market are expected to have a Quality Management System (QMS) certified under ISO 13485:2016. This applies to medical device manufacturers, medical device developers, manufacturers of medical device parts or components, service providers for medical device installation, and EU distributors or importers. Canadian medical device regulations require QMS certification under the Canadian version CAN/CSA-ISO 13485:2016 medical devices QMS. Malaysia has the Medical Device Act (Act 737), which requires all manufacturers to have implemented a QMS according to the ISO 13485 standard. Singapore requires that medical device manufacturers have an ISO 13485 QMS, which can be found in the document “Health Products (Medical Device) Regulations 2010.” Although some of these countries have slightly different requirements for design controls, they utilize the ISO 13485:2016 standard in some capacity.
I've found that several nations have policies in place for development that are in compliance with ISO 13485:2016. There is a SOR 98-282 in Canada. Canadians employ medical technology to maintain and improve their health and wellness. Canada has one of the best regulatory regimes for medical devices, with some of the harshest rules in the world. To further ensure the safety, effectiveness, and standard of the medical equipment used by Canadians, the Canadian government is taking action.
According to the Hon. Ginette Petitpas Taylor, Minister of Health, Health Canada has developed an Action Plan to expedite its efforts to strengthen the regulation of medical devices in Canada and to better ensure optimal health outcomes for Canadians. This strategy provides a three-pronged effort to further improve the process by which medical devices are placed on the market, to improve monitoring and follow-up for presently in use devices, and to improve Canadians' knowledge about the medical devices they rely on.
