Category
Medical and Healthcare products Type Approval by Country
Medical and health devices with wireless connectivity, from monitors and meters to imaging systems.
Type approval required in
🇧🇼 Botswana🇧🇮 Burundi🇪🇬 Egypt🇬🇭 Ghana🇲🇷 Mauritania🇲🇺 Mauritius🇳🇦 Namibia🇳🇬 Nigeria🇷🇼 Rwanda🇸🇱 Sierra Leone🇿🇦 South Africa🇹🇿 Tanzania🇬🇲 The Gambia🇹🇬 Togo🇺🇬 Uganda🇿🇲 Zambia🇧🇸 The Bahamas🇭🇰 Hong Kong🇯🇵 Japan🇰🇷 South Korea🇧🇭 Bahrain🇮🇶 Iraq🇱🇧 Lebanon🇴🇲 Oman🇶🇦 Qatar🇸🇦 Saudi Arabia🇸🇾 Syria🇦🇪 United Arab Emirates🇾🇪 Yemen🇧🇲 Bermuda🇨🇦 Canada🇲🇽 Mexico🇦🇺 Australia🇫🇯 Fiji🇰🇮 Kiribati🇳🇷 Nauru🇳🇿 New Zealand🇵🇬 Papua New Guinea🇼🇸 Samoa🇹🇴 Tonga🇻🇺 Vanuatu🇦🇷 Argentina🇧🇷 Brazil🇨🇴 Colombia🇦🇫 Afghanistan🇮🇳 India🇳🇵 Nepal🇱🇰 Sri Lanka🇧🇳 Brunei🇰🇭 Cambodia🇮🇩 Indonesia🇱🇦 Laos🇲🇾 Malaysia🇵🇭 Philippines🇸🇬 Singapore🇹🇭 Thailand🇻🇳 Vietnam
Requirements by country
| Country | Authority | Scope | Note | Lead time | Requirements |
|---|---|---|---|---|---|
| Botswana | BOCRA | In scope | – | 2-12 weeks | Requirements → |
| Burundi | ARCT | In scope | – | 22 working days | Requirements → |
| Egypt | NTRA | In scope | – | Paperwork: 14 days. Local Testing 4-5 weeks. | Requirements → |
| Ghana | NCA | In scope | – | 15 days | Requirements → |
| Mauritania | ARE | In scope | – | 2 months | Requirements → |
| Mauritius | ICTA | In scope | – | 4 weeks | Requirements → |
| Namibia | CRAN | In scope | – | 40 days | Requirements → |
| Nigeria | NCC | In scope | – | 30 days | Requirements → |
| Rwanda | RURA | In scope | – | 5 days and 10 days | Requirements → |
| Sierra Leone | NatCA | In scope | – | Based on NatCA estimation | Requirements → |
| South Africa | ICASA | In scope | – | 30-45 days | Requirements → |
| Tanzania | TCRA | In scope | – | 14 working days | Requirements → |
| The Gambia | PURA | In scope | – | 2-4 weeks | Requirements → |
| Togo | ARCEP | In scope | – | Approximately 1-2 months | Requirements → |
| Uganda | UCC | In scope | – | Typically 5-6 weeks | Requirements → |
| Zambia | ZICTA | In scope | – | 5-15 days | Requirements → |
| The Bahamas | URCA | In scope | – | Typically 4-8 weeks | Requirements → |
| Hong Kong | OFCA | In scope | – | 15 working days | Requirements → |
| Japan | MIC | In scope | – | 3–4 weeks | Requirements → |
| South Korea | RRA | In scope | – | About 8 weeks | Requirements → |
| Bahrain | TRA | In scope | – | 14 days | Requirements → |
| Iraq | CMC | In scope | – | 2 weeks | Requirements → |
| Lebanon | TRA | In scope | – | 6 weeks | Requirements → |
| Oman | TRA | In scope | – | 7-10 days | Requirements → |
| Qatar | ICT | In scope | – | Simplified Type Approval: 5 days. Standard Type Approval: 15 days | Requirements → |
| Saudi Arabia | CST | In scope | – | About 2 weeks | Requirements → |
| Syria | SY-TPRA | In scope | – | 20 days | Requirements → |
| United Arab Emirates | TDRA | In scope | – | 3-5 working days | Requirements → |
| Yemen | MTIT | In scope | – | 4–8 weeks | Requirements → |
| Bermuda | RA | In scope | – | 2-3 weeks | Requirements → |
| Canada | ISED | In scope | – | Typically 4-6 weeks | Requirements → |
| Mexico | CRT | In scope | – | NOM: 3-5 weeks. CRT: 20 business days. | Requirements → |
| Australia | ACMA | In scope | – | 5 business days | Requirements → |
| Fiji | TAF | In scope | – | 10 working days | Requirements → |
| Kiribati | CCK | In scope | – | 7 days | Requirements → |
| Nauru | NCA | In scope | – | Not publicly specified by the NCA | Requirements → |
| New Zealand | RSM | In scope | – | 2 weeks | Requirements → |
| Papua New Guinea | NICTA | In scope | – | 10 days | Requirements → |
| Samoa | OOTR | In scope | – | 30 days | Requirements → |
| Tonga | CCT | In scope | – | 5 days | Requirements → |
| Vanuatu | TRBR | In scope | – | 30 days | Requirements → |
| Argentina | ENACOM | In scope | – | 12-14 weeks | Requirements → |
| Brazil | ANATEL | In scope | – | 8–12 weeks | Requirements → |
| Colombia | CRC | In scope | – | 3-4 weeks | Requirements → |
| Afghanistan | ATRA | In scope | – | 30 days | Requirements → |
| India | WPC ETA and TEC MTCTE | In scope | – | WPC ETA certification is around 1 to 2 weeks. TEC MTCTE certification takes around 8-12 weeks | Requirements → |
| Nepal | NTA | In scope | – | 4 weeks | Requirements → |
| Sri Lanka | TRCSL | In scope | – | 30 days | Requirements → |
| Brunei | AITI | In scope | – | 2 weeks | Requirements → |
| Cambodia | TRC | In scope | – | 15 working days | Requirements → |
| Indonesia | DJID | In scope | – | Local Testing around 5 weeks and Paperwork is about 3-5 week. | Requirements → |
| Laos | MTC | In scope | – | Paperwork: 10 working days. Local Testing: Take several additional weeks | Requirements → |
| Malaysia | SIRIM | In scope | – | Paperwork about 2weeks. Local testing approximately 4 to 6 weeks. | Requirements → |
| Philippines | NTC | In scope | – | 20-25 business days | Requirements → |
| Singapore | IMDA | In scope | – | 3 days (M2M: 2–3 months) | Requirements → |
| Thailand | NBTC | In scope | – | 4–8 weeks | Requirements → |
| Vietnam | MoST | In scope | – | 5–6 weeks | Requirements → |
Products in this category
- Blood Glucose Monitoring systemsMeters and continuous sensors that measure blood glucose and often send readings to a phone over Bluetooth.
- Blood pressure monitoring systemDevices that measure blood pressure, including ambulatory monitors and models that sync results by Bluetooth.
- MRI systemMagnetic resonance imaging equipment used in hospitals, which uses strong magnetic fields and radio frequency energy.
- Smart Operating TableA motorised operating table with electronic positioning and connectivity for operating room systems.
- Digital RadiographyX-ray imaging systems with digital detectors, often with wireless detector panels.
- Smart syringe pumpAn infusion pump that delivers medication at a set rate, with connected models reporting to hospital systems.
- Body Height measurementElectronic stadiometers that measure body height, some sending results wirelessly.
- Body weight measurementSmart scales that measure weight and body composition and sync results by Bluetooth or Wi-Fi.
- Bluetooth OximeterA pulse oximeter that measures blood oxygen and pulse and sends readings to a phone over Bluetooth.
- Patient MonitorBedside and portable monitors that track vital signs such as heart rate, oxygen and temperature.
- Digital ThermometerAn electronic thermometer, including contact, infrared and connected models.
- Electrocardiogram (ECG)Devices that record the heart’s electrical activity, from hospital ECG machines to portable and wearable ones.
Topics
Basics
- What is a Smart Thermostat? Does It Save Money?This article will provide information related to smart thermostats, starting from the definition, how they work, and their functions.
- What is a Patient Monitor? Know Its Functions and TypesThis article will inform you more about patient monitors from the definition, working methods, functions, types, and regulations in Indonesia.
- What is MRI (Magnetic Resonance Imaging)?This article will discuss MRI technology, starting from its definition, how it works, its functions, its benefits, the differences between CT scan…
Types
- Exploring the 5 Types of Digital ThermometersAs we know, digital thermometers can be used through the mouth, armpit, or rectum. Some of its uses are included in the types of digital…
Pros and cons
- Knowing the 5 Crucial Advantages of Patient MonitorA patient monitor is an indispensable tool that greatly assists medical staff. One of the advantages of a patient monitor is that it helps monitor a…
- Advantages and Disadvantages of Pulse OximeterThe advantages and disadvantages of pulse oximeters include easy to use and can monitor routine conditions, less accurate in certain patients, and…
- What is a Digital Thermometer? Learn How It Works and its BenefitsTechnology has penetrated various industrial sectors, one of which is healthcare. A Digital Thermometer is one of the tools that support digital…
- What is Continuous Glucose Monitoring? Learn Its BenefitsOne of the developments of wireless power transmission (WPT) technology in the health sector is Continuous Glucose Monitoring (CGM).
Practical tips
- 5 Tips for Choosing a Smart ScaleA smart scale is one of the devices that supports public awareness of maintaining health. So, tips for choosing a smart scale are quite necessary to…
See also
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