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/

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.

http://www.pacificbridgemedical.com/regulation/japan-medical-device-regulations/

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.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4221680/
http://www.fdanews.com/articles/182314-south-africa-new-device-regs-are-now-live
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3326589/

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.
http://www.who.int/medical_devices/publications/en/MD_Regulations.pdf.

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.

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."

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

http://agreement.asean.org/media/download/20141204115621.pdf
http://www.eibn.org/upload/EIBN_Indonesia_Medical_Device_regulation.pdf

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.

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

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.

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.

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