Standards, testing & ancillary approvals by country

Devices with a measuring function must be operated (and serviced, § 44(2)) in compliance with the metrology legislation — Act No. 505/1990 Sb. on metrology and Vyhláška No. 345/2002 Sb. on measuring instruments subject to mandatory verification (e.g. eye tonometers, blood pressure monitors, audiometers, scales, electric clinical thermometers); verification of such instruments is performed by the Czech Metrology Institute (ČMI) or an authorised metrology centre.

Denmark applies the EU RoHS restriction on hazardous substances in electrical and electronic equipment through BEK nr 1369 af 02/12/2024 (issued under the chemicals act), which covers EEE in the Annex 1 product categories — including medical devices (the regulation itself defines active implantable medical devices by reference to MDR). DKMA lists this regulation in its medical device legislation overview.

Use of harmonised standards is voluntary: devices in conformity with relevant harmonised standards (or parts) whose references are published in the OJEU are presumed to conform with the MDR requirements they cover; this also applies to system/process requirements for economic operators (QMS, risk management, PMS, clinical evaluation/PMCF) (Art. 8(1) MDR). Equivalent rule for IVDs: Art. 8 IVDR.

Radiation safety of the use of devices producing ionizing radiation (radiation devices, radioactive substances and radiation practices) is additionally governed by the Radiation Act (859/2018); devices producing non ionizing radiation and devices equated with them by operating principle are also covered insofar as they cause population exposure to radiation.

After registration, any imported condom consignment is detained, sampled and analysed on a batch to batch basis and released only if it passes quality evaluation at the FDA Medical Devices Laboratory.

COSQC examines samples of imported goods referred by the General Customs Authority, the Ministry of Health and other ministries; it operates a pre shipment inspection and testing program before supply in the country of origin or export, and runs a dedicated conformity assessment department for imported goods (قسم تقويم المطابقة للسلع المستوردة).

Lithuania maintains a national 'technical condition inspection' regime for in use devices: a mandatory inspection of the device, including verification of all parameters and safety tests, carried out within the time limits and procedure set by device usage legal acts and the manufacturer; VASPVT issues the permits entitling persons to perform such inspections (Art. 75(2)(8)).

Under HSL Art. 59 2(4 1) (added 2024 06 21), failure to adopt a decision on issuing or refusing the permit entitling a person to perform medical device technical condition inspection within the time limit set in Art. 59 2(4) is not deemed to be issuance of the permit.

Medicines, medical devices and other health supplies are governed by the Farmacopea de los Estados Unidos Mexicanos (LGS Art. 195, paragraph reformed DOF 10 05 2023), which the Secretaría keeps permanently updated; device registrations require laboratory tests verifying product specifications (RIS Art. 179 VII).

Products, equipment, devices or apparatus intended for telecommunications or broadcasting that can be connected to a network or use the radioelectric spectrum must be homologated under applicable NOMs or Technical Provisions (LFTR Art. 289); the obligation is not limited to public networks. The IFT homologation lineamientos provide a Tipo A registry applicable to scientific, medical or industrial equipment, subject to non interference conditions.

Rule 68 provides that the standards for testing of medical devices shall be in accordance with the international standards; the rules do not name a mandatory local standard, and conformity evidence accepted elsewhere in the rules consists of ISO 13485, CE marking by NANDO notified CABs, WHO prequalification and free sale certificates.

DNDM has issued product specific rules: Resolución 066/2021 (Laboratorio Central de Referencia for IVDs), Resolución 037/2022 (waives diagnostic evaluation for self applied SARS CoV 2 antigen tests within registration), Resolución 694/2023 (classification of dressings with active ingredient), Resoluciones 004/2023 and 003/2024 (latex condom importation), Resolución 001/2021 (storage and distribution guidelines) and Resolución 001/2023 (good storage practices).

Health units must ensure periodic verification of medical devices in use as required by law (Legea 95/2006 art. 933(1)(h)); Ordin 2219/2022 sets the devices subject to control and verification periodicity in its annex 1, requires a responsible person and register of devices in use (art. 20), and prohibits use of devices that fail the tests (art. 21(1)).

Second hand medical devices may be used only following performance evaluation by ANMDMR and its aviz, and must bear CE marking (Legea 95/2006 art. 931(1)).

MHRA publishes designated standards lists in support of the Medical Devices Regulations 2002 (as amended), with a consolidated list (version 2, dated 17 January 2026) available for reference by businesses; conformity with a relevant designated standard supports compliance with the essential requirements.

Where the measuring and test means or test conditions required for device sample testing do not exist in Uzbekistan, the tests may be conducted at the foreign manufacturer's testing laboratory or at other foreign laboratories with the participation of the Centre's specialists.