Medical device regulatory developments - medical device inspection work specifications

Work specification for medical device inspection:

The inspection institution shall, in accordance with the relevant laws and regulations of the state, implement the environmental protection, safety control and personnel health protection of the inspection institution, and standardize the dangerous goods and wastes

The management and disposal of abandoned materials and experimental animals shall be strengthened, safety inspection shall be strengthened, and emergency disposal procedures for inspection accidents shall be formulated to ensure the safety of inspection work and public safety

Encourage and support inspection institutions to effectively use information technology and other technology and data sharing platforms, and actively carry out innovation in inspection technology, inspection equipment, reference materials, etc

New R & D work.

The inspection organization shall be equipped with personnel suitable for the inspection work to ensure that the professional field and quantity of its personnel match the inspection work and standardize the selection of personnel

Selection, training, supervision, authorization and monitoring management.

When accepting the samples, the inspection institution shall obtain the product technical requirements, technical data, standards / references and other auxiliary supplies necessary for the inspection

Etc.