Legal basis
"Supervision and Administration of Medical Devices Regulations" Article 31
To engage in the operation of Class III medical devices, the business enterprise shall be located in the municipal people's government of the municipal food and drug supervision and management department to apply for a license to operate and submit the conditions of its conformity with the provisions of Article 29 of the Regulations of the proof of information. The Acceptance of applications for business license food and drug supervision and management department shall be accepted within 30 working days from the date of review, if necessary, the organization verification. To meet the prescribed conditions, permit and issue a medical device license; do not meet the prescribed conditions, not permit and explain the reasons in writing. Medical device license is valid for 5 years. The expiration of the validity of the need for continuation, in accordance with the relevant administrative licensing law for the continuation of the procedures.