October 30, 2017 at 2:04 am #4784
The regulation of medical devices across the world is very varied, ranging from comprehensive to none.
Here in USA : Design Control – States that when manufacturers or suppliers develop a product subject to design controls, they shall establish and maintain the proper documentation to ensure the specified design requirements are met..
my question is, are the Design Controls used in the other countries ? (do web research)
United Arab Emirates (UAE):
Classification requirements and the evaluation of Devices follow international regulations and
guidelines, mainly those of:
– the IMDRF for Medical Devices,
– the US Food and Drug Administration’s Devices Regulation… so, in UAE you have to do design controls when making a medical device.( http://dgra.de/media/pdf/studium/masterthesis/master_samadi_f.pdf)
Also, Dr.Simon mentioned in the class that Design Controls are not “needed” in the EU (http://medicaldevicecourses.com/forums/topic/discussion-topic-supplemental-on-dhf-and-dmr/)
October 30, 2017 at 4:26 am #4785
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.”
- This reply was modified 5 months, 3 weeks ago by zbw2.
October 30, 2017 at 4:26 am #4786
November 1, 2017 at 10:00 am #4790
Another country to heavily regulates medical devices such as their design controls is Japan which falls under Japan’s Pharmaceutical and Medical Device Agency (PMDA) and works in conjunction with the Ministry of Health, Labor and Welfare to ass new product safety, development regulations and monitor post market safety. Currently all new medical device development must follow regulations laid out by the PMD Act (Introduced and forced on November 24, 2014 replacing the previous act called Pharmaceutical Affairs Law (PAL)), known as the act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products. Gene Therapy Products and Cosmetics. The PMD Act states the following:
“Some Class III medical devices are able to undergo third party certification.
Medical software programs are independently regulated.
Manufacturers are required to be registered rather than be licensed.
Quality management systems (QMS) are streamlined. QMS inspection is conducted on the Marketing Authorization Holder and is conducted per product family, not on individual products.”
The classification system in Japan differs from that of the United States or the EU. In Japan the device classification for medical devices are Class I, II, III or IV depending on their risk level. All medical devices must comply with Japanese Industrial Standards, these standards define industry-wide safety and performance requirements; similar to ISO.
Another difference compared to the U.S and EU is that all medical devices must obtain specific certification depending on what risk level the medical device falls under. For example, Third Party Certifications are needed for low risk medical devices. A Minister’s Approval on basis of PMDA review is needed for high risk medical devices. Compared to the U.S it is just between Pre-Market Approval and Pre-Market Notification 510K. For EU it is just Notified Body Certification for all medical devices. In Japan the medical device approval process follows the PMDA > Reviews against essential principles and Summary data Subsets > Reliability Review for data reliability, GLP, GCP, GMP conformity and post approval inspection.
November 1, 2017 at 10:22 am #4791
After doing some research, I chose to pick an area where design controls were not in place. Within the African continent, only 7% of the 46 sub-Saharan countries had a regulatory policy, National Medicines Regulatory Authorities (NMRA), in place (2005). The rest of the countries in the continent have either minimal regulatory policy in place (estimated at 63%) and the remaining 30% had no design control regulations whatsoever. However a number of organizations have since been established to encourage a normalization of policy throughout the continent. These include: African Organization for Standardization (ARSO), The African Network for Drugs and Diagnostic Innovation (ANDI), African Union (AU) and United Nations Economic Commission for Africa (UNECA).
More recently, as of June 1st 2017, the South Africa established its first regulatory system for medical devices and in vitro diagnostics. The new independent state-owned regulatory entity is called the South African Health Products Regulatory Authority (SAHPRA) and will regulate both drugs and devices.
November 1, 2017 at 8:41 pm #4799
There are design controls in most countries that design and manufacture medical devices. There are all specific to their particular country and must follow the standards given by that particular country. However, that are many med-devices that can be found in different country’s under the same company name. There are medical device regulation consulting groups that would service specific countries insuring that the design controls are upheld with the particular standards of that country.
The company Emergo group is one of these companies (https://www.emergogroup.com/). There are standards that they follow as well that apply on a global scale.
November 2, 2017 at 11:20 am #4802
The idea, in general, is that there are two basic kinds of regulatory systems:
A) Systems that document the current snapshot of the device’s design/manufacture/risk profile, etc.
B) Systems that document the whole history of the device’s design/manufacture/risk profile from development up through marketing
Both systems nowadays require post-market surveillance and will increase this burden as time passes.
The EU, Australia, and countries like that have System A. Countries like the US, China, Japan, Brazil have System B, which relies on Design Controls.
In my opinion it started this way because System A reflects a regulatory system that focuses on Trade and System B reflects a regulatory system run by a Human Health and Services organization, i.e. public health. Naturally, you should see that both of them overlap and they will start overlapping more and more as they begin to converge.
There’s a System C as well…. little or no regulatory. You don’t have to go as far as Africa to see this type. Look at India for an interesting case.
- This reply was modified 5 months, 2 weeks ago by Josh.
November 5, 2017 at 11:45 pm #4947
Currently, the Indian medical device and pharmaceutical market is largely unregulated and medical devices can be freely imported into the country. The Ministry of Health and Family Welfare and the Central Drugs Standard Control Organization (CDSCO) are the two regulatory bodies that are responsible for overseeing medical devices within India. The CDSCO exercises regulatory control over the import of medical devices and approves new medical devices and clinical trials. The CDSCO also oversees the Central Licensing Approving Authority (CLAA), the body responsible for ensuring medical device compliance. Under India medical device regulations, only certain medical devices require pre-market review, while other products that are typically regarded as devices are instead classified as drugs.
November 2, 2017 at 8:05 pm #4818
I did research about the regulations in India, and I found that, India is one of the largest medical device markets in Asia, and is still growing at an impressive rate. Prior to 2005, no medical device regulations existed in India! -(System C as DR.Simon mentioned),
The registration process for medical devices in India remains fluid, but regulators are taking steps to develop a more formalized oversight policy. Also, no specific medical device classification currently exists in India.
For clinical trials: if your product has already obtained US-FDA clearance or approval, for example, you will not need to conduct further clinical trials in India!
However, today there are new registration procedures for certain types and classes of medical devices regulated under the provisions of the Drugs and Cosmetics Rules. The new regulations will take effect on January 1, 2018 in India:
” Manufacturers interested in registering their medical devices in India must supply evidence of prior regulatory authorization in the US, Canada, Europe, Australia or Japan, as well as proof of approval in their home market. Additionally, each manufacturing facility must be registered.”
- This reply was modified 5 months, 2 weeks ago by merzkrashed.
November 2, 2017 at 10:18 pm #4821
The regulation of Medical Devices across the world is varies a lot, ranging from comprehensive to
none. Some countries have a developed structure for regulation of Medical Devices, while some are partially done and the rest are either in the process of developing a structure or do not yet have any regulation.
A country like Indonesia have a Medical Device directive that provides a more straightforward path to the market for medical device manufacturers. It was put together by Southwest Asian countries like Indonesia, China, Malaysia, Thailand etc. It is called ASEAN Medical Device Regulations
November 4, 2017 at 3:53 pm #4836
As Rashed mentioned, no medical device regulations whatsoever existed in India before 2005. It’s pretty stunning to consider that such a large market (over 1.3 billion) could have such lax regulatory affairs in such a critical field. However, it’s less surprising when considering that India has long been plagued with medical treatments of poor (or even negative) value. Even today, Homeopathic Medicine dominates significant segments of the Indian medical system.
Increasing wealth has resulted in a larger, better educated middle class. As a result, India has been undergoing a number of cultural and governmental developments. One of these is increased regulatory attention toward the growing medical device development field. The expected approval time for new devices is 6-9 months currently (with a technical presentation adding another 3-6 months). Again as Rashed mentioned, devices must show previous approval in the US, Canada, an EU country, Australia, or in Japan to obtain registration without going through a lengthier approval process.
November 4, 2017 at 5:38 pm #4844
Design controls designate the application of a formal methodology to the conduct of product development activities. It is often mandatory (by regulation) to implement such practice when designing and developing products within regulated industries (e.g. medical devices).
Many AdvaMed members have made substantial investments in China, including the establishment of research and manufacturing facilities and other efforts that contribute to China’s growth. Survey results from just two dozen AdvaMed members reflect:
Decades of experience in China, some more than a century.
Approximately 60,000 employees, with thousands in R&D.
Nearly 300 offices across the country.
Over 8 billion RMB in fixed assets, 30% through joint ventures and over 40% through controlling investments in local firms, nearly all belonging to a Chinese healthcare association.
R&D collaborations with Chinese academic institutions.
Medical education delivered to about 100,000 health care professionals each year, with nearly 100 customer training centers around the country.
Tens of millions RMB in annual donations to Chinese charities.
AdvaMed advocates in China for the highest ethical standards, timely patient access to safe and effective products, and economic policies that reward value creation. In 2014, AdvaMed expanded its commitment to China by opening an office in Shanghai, enhancing our ability to work with all stakeholders – including manufacturers, patient groups, health care providers and Chinese authorities – to advance medical technology innovation and value-based health care centered on quality.
The main policy agenda has four main focus areas:
Technology and Regulatory
Payment and Health Care Delivery
Legal and Compliance
Global Strategy and Analysis
November 4, 2017 at 6:01 pm #4847
Government agencies responsible for regulating Medical Devices in India.
1. The Central Drug Standards Control Organization (CDSCO) is India’s main regulatory body for pharmaceuticals and medical devices.
2. The Drug Controller General of India (DCGI) is the key official within the CDSCO. The DCGI is responsible for the approval of the manufacturing of certain drugs (vaccines, large volume parenterals, blood products, r-DNA derived), specific medical devices, and new drugs.
3. In India, the manufacturing, import, sale, and distribution of medical devices are regulated under India’s Drugs & Cosmetic Act and Rules (DCA).
In India Device classification Consistent with GHTF guidance and the EU medical device directives, Medical devices are to be classified as Class A (devices involving lowest risk levels such as thermometers, tongue depressors), Class B (low to moderate risks such as hypodermic needles, suction equipment),Class C (moderate to high risks such as lung ventilator, bone fixation) and Class D (highest risks such as heart valves, implantable devices). And India follows international standard ISO 13485: 2003 quality management systems for medical devices, published by the Bureau of Indian Standards (BIS) as Indian national standard IS 15579: 2005.
In India not all medical devices need registration Currently their is only 40-50 medical devices which require registration. For all other medical devices that do not require registration, the manufacturer should obtain a No Objection Certificate (NOC) from the DCGI. The NOC is a letter from the DCGI stating that the product does not require registration and can be imported freely into India.
November 4, 2017 at 10:08 pm #4860
To add in @ao242 comment about ASEAN Medical Device Regulations, Vietnam is one of the countries that import a lot of medical devices. In the past (before the end of 2016), there were 2 distinct bodies of legislation—one for medical devices manufactured in Vietnam and the other for imported ones. All domestically manufactured medical devices had to be registered and granted marketing authorization licenses from the Department of Medical Equipment and Health Works under the Ministry of Health before being circulated. These regulations are in accordance with the ASEAN Medical Device Regulations that has been mentioned in the previous post. The Foreign medical device did not require registration but had to obtain import licenses from the DMEHW to be imported and circulated in Vietnam. However, as of 2017, all imported medical devices are required to be registered for marketing authorization licenses.
November 5, 2017 at 2:46 pm #4884
November 5, 2017 at 4:38 pm #4892
What do you mean ‘Test-ab’?
November 5, 2017 at 6:27 pm #4899
Test-having trouble posting multiple sentences. disregard.
November 5, 2017 at 6:40 pm #4901
It was interesting to learn as @merzkrashed mentioned that the medical devices in India are largely unregulated. I came across this article/document which mentions that this is the case due to lack of medical device specific legislation on specifying standards of safety and quality for most medical devices. However this expected to change with the introduction of the Medical Device Rules, 2017 which is expected to take effect from January 1st, 2018.
Currently there are certain medical devices which are regulated by deeming these devices as “drugs” and thus they are regulated under the Drugs and Cosmetics Act, 1940. These medical devices are referred to a “Notified Medical Devices” and they
As the article states the Act and DC Rules seek “to regulate the import, manufacture, distribution and sale of Notified Medical Devices and ensure the availability of standard quality Notified Medical Devices to the consumer.
The list of Notified Medical Devices includes:
1. Disposable Hypodermic Syringes
2. Disposable Hypodermic Needles
3. Disposable Perfusion Sets
4. In vitro Diagnostic Devices for HIV, HBsAg and HCV
5. Cardiac Stents
6. Drug Eluting Stents
8. Intra Ocular Lenses
9. I.V. Cannulae
10. Bone Cements
11. Heart Valves
12. Scalp Vein Set
13. Orthopedic Implants
14. Internal Prosthetic replacements
15. Ablation Devices
I’ll be interested to see what the “Medical Device Rules” will be, which will come into effect Jan 1, 2018.
November 6, 2017 at 7:39 pm #4954
Trouble adding link to comments: nishithdesai /fileadmin/user_upload/pdfs/Research_Papers/The_Indian_Medical_Device_Industry
November 5, 2017 at 8:51 pm #4913
I see that there is brief discussion regarding the Medical Device regulation in India. There is no clinical trials or local testing of device if it is approved by other country market. I hope that this will be changed in near future. Being a most developing country in medical technology Medical device regulatory will be properly executed soon. But still there are few steps to get approved in India if the device is manufactured in India.
Appoint a local agent in India to be the applicant and license holder
Prepare Device Master File (DMF)
Prepare Plant Master File (PMF)
Prepare application Form w/supporting documents
Submit above documents to DCGI with fees
DCGI reviews and sends back an inquiry letter
Applicant responds and addresses inquiries made by the DCGI
DCGI may request technical presentation
November 5, 2017 at 11:07 pm #4939
Despite its small geographic size, Singapore has one of the largest and most advanced healthcare systems in the world. Singapore has robust healthcare infrastructure, so there is consistent demand for state-of-the-art medical technologies. Medical devices in Singapore are regulated by the Medical Device Branch of the Health Sciences Authority (HSA). Singapore is a member of the Association of Southeast Asian Nations (ASEAN) and its regulatory system is based on the Health Products Act 2007 and Health Products (Medical Devices) Regulations 2010. These regulations dictate how medical devices are classified in Singapore and the registration routes for each class.Device classification in Singapore is based on a four-tier system (Class A, B, C, and D), with Class A assigned to the lowest-risk products and Class D assigned to the highest-risk products. Devices with prior authorization in the US, Europe, Canada, Australia, or Japan are eligible for abridged evaluation routes.
November 12, 2017 at 2:03 am #5030
Much like India, Pakistan has only recently implemented a detailed regulatory environment. Until 2015, the Medical Device landscape was an almost fully rule-free environment, just as seen in India. In 2012, legislation was passed that called for quality assessments, conformity checks, and a registration process that would begin in 2015. Pakistan’s framework is based on the International Medical Device Regulators Forum and templates from the Association of Southeastern Asian Nations.
Devices are split into four classes, from A to D, in order of increasing potential risk. There are published guidelines for how the various characteristics of a device (for example, invasiveness and duration of usage) will help determine the class it is placed in.
November 12, 2017 at 10:55 pm #5076
I searched about the Korean Regulatory System
The Ministry of Health and Welfare (MHW) is the primary healthcare agency regulating the importation of medical devices. Under Korea’s Medical Devices Act, the Korea Food and Drug Administration (KFDA), an agency under MHW, independently regulates all medical devices; only when KFDA requests legislation to fulfill its mission is agreement with MHW required. The Medical Devices Act, passed by Korea’s National Assembly in 2003, is now fully in force with the requirement that all medical devices sold in Korea meet Good Manufacturing Practices (KGMP—more on this topic below). Imported medical devices require an original Certificate to Foreign Government (CFG) by the appropriate regulatory body in the product’s country of manufacture before they can be sold in Korea. KFDA requires foreign manufacturers to have local partners or a physical presence (business registration, along with office and warehouse space) in Korea rather than interact with regulators directly. All foreign suppliers must apply for either a manufacturing or importer business license in order to market medical devices. To obtain a business license, an importer must provide a copy of KFDA Form 1, a health certificate of the company representative, a copy of the registered legal entity, and a list of facilities.
An importer can have more than one distributor, but each distributor must either register as an importer, or have an independent consultant hold the product approval so each importer has equal access to it.
All medical devices require pre-market registration from KFDA before they can be manufactured locally or imported into Korea. There are two types of pre-market licenses: pre-market approval for Class II, III, and IV devices and pre-market notification for ClassI devices. Pre-market approval requires a Technical File Review, Safety and Efficacy Review (SER—may be required for devices with new-to-market features), and Type Testing, while pre-market notification requires only a documentary review of product information (no testing is required). A Technical File Review is a “general” technical file review for those products that are basically the same as an already approved product 2(similar to the U.S. 510-K approval), whereas a SER is required for devices unlike those currently available on the market (similar to the U.S. pre-market approval). KFDA now conducts a Technical File Review on all Class II, III, and IV products.
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