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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
7. Catheters
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.

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
Approval

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.

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.

Trouble adding link to comments: nishithdesai /fileadmin/user_upload/pdfs/Research_Papers/The_Indian_Medical_Device_Industry

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.

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.

New Zealand uses a classification system based on risk to the human body. Increasing risk is assigned to Classes I ,Ila, IIb, III, and AIMD respectively. In New Zealand, market entry does require listing your product in MedSafe's Web Assisted Notification of Devices (WAND) database within 30 days of commercialization. Before it, there is documentation that proves device's safety and effectiveness .Though manufacturers are free from obtaining pre-market approvals to enter the region, the proposed legislation changes and the willingness of New Zealand government to overhaul its existing Regulatory system might deviate market entrants with unclear Regulatory requirements. WAND listing includes the following information:
* Risk classification of the device
* Manufacturer's contact information
* Global Medical Device Nomenclature (GMDN) Code
* Intended purpose of the device
Medsafe, the drug and medical device authority of New Zealand has taken steps towards this introducing a web-based online database however, only for the notification of devices in the market which means, there is no premarket assessment for all devices that get sold in the market. The notification process is comparatively very easy and the documentation that is prioritized by Medsafe is only the evidences of the device registration in other countries, like the FDA clearance, the CE certificate or the ARTG listing.

Investment in artificial intelligence (AI) and digital health technologies has increased exponentially over the last few years. In the United Kingdom, the excitement and interest in this space has been supported by NHS policies, including proposals in the NHS Long Term Plan. The plethora of new technologies has led to increased calls for regulation and oversight, particularly around data quality and evaluation. Many of these concerns may be addressed by the new Medical Device Regulation (MDR) and other regulatory developments. In May 2020, the new MDR will change the law and process of certification for medical software. The new law includes significant changes for digital health technologies which are medical devices. In March 2019, the National Institute for Health and Care Excellence (NICE) also published a new evidence standards framework for digital health technologies. The Care Quality Commission (CQC) already regulates online provision of health care, and there are calls for wider and greater regulation. The government has also published a code on the use of data in AI. 

The new MDR will mean a significant change to the regulatory framework for medical devices in the European Union. As with the previous law, the MDR regulates devices through a classification system. The new regime introduces new rules for medical software that falls within the definition of device. This will mean significant changes for companies that develop or offer medical software solutions, especially if their current certification has been “up-classed” under the MDR.

The MDR sets out some specific criteria around the classification of medical software, which is likely to mean that many devices which currently qualify as class I under the existing regime (MDD) may move up a class under the MDR.

The new rules are as follows:

• Software intended to provide information used to take decisions with diagnosis or therapeutic purposes are Class IIa.

• Software, where these decisions have an impact that may cause a serious deterioration of a person’s state of health or a surgical intervention, are Class IIb.

• Software, where these decisions have an impact that may cause death or an irreversible deterioration in a person’s health, are Class III.

• All other software is Class I.

Whilst some software may remain as Class I, many devices are likely to move up a class level.

This will mean more onerous responsibilities and increased rigour (and time) in relation to the certification of the device.

The design control process in Turkey is done by the Turkish Medicines and Medical Devices Agency. It follows ISO 13485 and ISO 9001. For Turkey, medical devices must have CE markings and must be registered in the Turkish Ministry's Online Database of Turkish Drug and Medical Device national Databank. CE marking is a claim from the manufacturer that says the product meets all relevant European medical device standards' essential requirements. As can be guessed, documentation must be in Turkish. Finally, the medical device and product must have a local and authorized representative to go through the process of device control.

I did a search about Jordan regulation and i really found it interesting. As it is a small country, i did not found anything about development of medical devices, but all the regulation are based on device coming from other counties. In one of the Docs i red it stated "The Jordan Food and Drug Administration (JFDA) is responsible for the registration and approval of Medical Devices. All Medical Devices must meet certain requirements before they can be imported and used within Jordan." 

The required Docs are: FDA certificate, CE certificate and FSC. In addition, used or refurbished Medical devices are not permitted to be used in Jordan which i really found interesting.

Design control been included into the ISO regulation was a big plus. This has enabled medical device companies in other countries to have a set standard to work with.

Thus, Design controls are mandated so that medical device companies can prove that product is safe, effective, and meets its intended use requirements. Design controls do not just aid product development, they are product development. What is more, they have a real impact on the success of medical device.

That been said, some African countries that have small medical device company sometimes over look the ISO 13485:2016 regulations because they see this as cumbersome to follow up with especially with the documentations. These companies don’t have dedicated Quality or Regulatory compliance managers like the large multinational companies. For these small local companies, simply navigating the concepts, objectives and “requirement” is highly frustrating, not to mention ISO 13485 QMS. Most times they result into importing of these medical device. Implementing ISO 13485 in Medical Device companies in Africa is difficult, it takes enormous effort, can disrupt the business and could be costly, if not effectively managed.

https://www.certvalue.com/iso-13485-certification-in-south-africa/

https://www.dicardiology.com/article/5-tips-medical-device-engineers-fda-design-controls

In the US, the FDA regulates and implements design controls. However, there are similar governing bodies and procedures in other countries. For example, in China, there is the Chinese Food and Drug Administration enforces GMP in China. In Japan, there is the Pharmaceutical and Medical Device Agency. There are the National Medicines regulatory agencies; in Denmark, the Danish Medicines Agency, etc. These agencies have implemented similar regulate medicines and medical devices in their respective jurisdiction. They may not have set guidelines as strict as the US, but they do regulate certain procedures for making quality products. 

Many countries incorporate design controls into their laws and regulations. When researching ISO 13485:2016, I found that countries like Japan, Australia, Brazil, and Canada. Like the other countries listed in Japan, TGA must ensure that design and development changes are identified, and records are maintained. In addition, they must ensure that the changes are reviewed, verified, and validated as appropriate and approved before the implementation. The review of the design and development changes includes evaluating the effect of the changes on the constituent parts and products already delivered. Each country follows Medical Device Single Audit Program, where it makes sure that protocols are being followed. This is the same reason many of the countries have adopted design controls. Design controls ensure that when medical devices are designed and manufactured, they do what they are supposed to do and do not compromise safety.