Does my medical device need CRC type approval and conformity mark for information and communication equipment in Mongolia?

Maintained country rule

What this CRC type approval and conformity mark for information and communication equipment check is screening

Checks Wi-Fi, Bluetooth, cellular, NFC, RFID, UWB, telemetry, and proprietary radio approval. Applies when the product, feature, component, or use is in scope.

Source association reviewed. The source association has been reviewed. This does not verify every rule, date or product-specific conclusion; read the cited provisions and their limits.

Requirement family

Radio and spectrum approval

Regulatory object

radio and terminal equipment

Maintained rule status

mandatory if feature

Useful product facts

Radio technologies, bands, power, antenna, module model, approval IDs, and host integration changes.

The CRC's certification page divides certification into заавал (mandatory) and сайн дурын (voluntary) and states that information and communication equipment — network and terminal equipment — on the list approved by Annex 1 of Government Resolution No. 291 of 2018 ('Тохирлын баталгаанд заавал хамруулах бүтээгдэхүүн, үйлчилгээний жагсаалт') must be certified, while industrial and household electrical equipment outside that list may be certified voluntarily; the CRC's register of approved procedures identifies the governing instruments as 'THE TYPE APPROVAL REGULATORY GUIDELINE FOR THE INFORMATION AND COMMUNICATION EQUIPMENT', Resolution No. 29 of 2019, and the conformity-mark guidance, Resolution No. 43 of 2019 (CHTJ010-2019). The application file requires the manufacturer's or supplier's declaration of conformity, the manufacturer's or supplier's authorisation, and test results produced within the previous six years covering health and safety, electromagnetic compatibility (EMC) and radio spectrum (RF), with the equipment's frequency band, output power, modulation type, channel spacing and antenna gain; the CRC certifies that the equipment meets the standard requirements, does not affect human health adversely and does not interfere with other networks, and issues a conformity certificate after its non-staff Certification Assessment Committee decides, notifying the applicant within 5 working days of the decision. The certificate is issued under the conformity-mark procedure and the holder may apply the mark. The fee is set by the annex to Board Resolution No. 13 of 28 February 2020 ('Мэдээлэл, харилцаа холбооны тоног төхөөрөмжид баталгаажуулалт хийх төлбөрийн хэмжээ') and varies by assessment scheme. Two limits on this row: the guideline text and the Annex 1 list itself were not retrieved (the register page carries no per-document link and new.crc.gov.mn did not resolve), so whether a given radio-equipped medical device falls on the mandatory list is not established here; and the mandatory character and the document list are asserted on the CRC's own published pages, which are what this row is bound to.