Product · Medical and Healthcare products
Bluetooth Oximeter Type Approval by Country
A pulse oximeter that measures blood oxygen and pulse and sends readings to a phone over Bluetooth.
Type approval required in
🇪🇬 Egypt🇬🇭 Ghana🇲🇺 Mauritius🇳🇬 Nigeria🇿🇦 South Africa🇭🇰 Hong Kong🇯🇵 Japan🇰🇷 South Korea🇧🇭 Bahrain🇮🇶 Iraq🇱🇧 Lebanon🇴🇲 Oman🇶🇦 Qatar🇸🇦 Saudi Arabia🇸🇾 Syria🇦🇪 United Arab Emirates🇾🇪 Yemen🇧🇲 Bermuda🇲🇽 Mexico🇦🇺 Australia🇫🇯 Fiji🇰🇮 Kiribati🇳🇿 New Zealand🇵🇬 Papua New Guinea🇼🇸 Samoa🇹🇴 Tonga🇻🇺 Vanuatu🇦🇷 Argentina🇧🇷 Brazil🇨🇴 Colombia🇦🇫 Afghanistan🇮🇳 India🇱🇰 Sri Lanka🇧🇳 Brunei🇰🇭 Cambodia🇮🇩 Indonesia🇱🇦 Laos🇲🇾 Malaysia🇵🇭 Philippines🇸🇬 Singapore🇹🇭 Thailand🇻🇳 Vietnam
Requirements by country
| Country | Authority | Scope | Note | Lead time | Requirements |
|---|---|---|---|---|---|
| Egypt | NTRA | In scope | – | Paperwork: 14 days. Local Testing 4-5 weeks. | Requirements → |
| Ghana | NCA | In scope | – | 15 days | Requirements → |
| Mauritius | ICTA | In scope | – | 4 weeks | Requirements → |
| Nigeria | NCC | In scope | – | 30 days | Requirements → |
| South Africa | ICASA | In scope | – | 30-45 days | 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 → |
| 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 → |
| 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 → |
| 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 → |
Topics
Pros and cons
- 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…
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