Legal analysis: engaged in the production of Class I medical devices, by the manufacturer to the local municipal people's government food and drug supervision and management department for the record and submit its compliance with the conditions of Article 20 of these regulations to prove the information.
Engaged in the second, third class medical device production, the manufacturer shall apply to the local provincial, autonomous regions, municipalities directly under the Central People's Government of the Food and Drug Administration to apply for production licenses and submit its compliance with the conditions set out in Article 20 of the Ordinance, as well as the production of medical devices and medical device registration certificate.
Acceptance of applications for production authorization of food and drug supervision and management department shall accept the application within 30 working days from the date of application for review, in accordance with the State Council food and drug supervision and management department to develop the requirements of the quality management standard for the production of medical devices for verification. Meet the requirements of the conditions, and issued a permit and medical device production license; do not meet the requirements of the conditions, not licensed and the reasons in writing.
Medical device manufacturing license is valid for five years. The expiration of the validity of the need for continuation, in accordance with the relevant provisions of the law for the continuation of administrative licensing procedures.
Legal basis: "Supervision and Administration of Medical Devices Regulations" Article 21 engaged in the production of Class I medical devices, by the manufacturer to the municipal people's government of the location of the food and drug supervision and management department for the record and submit it to comply with the conditions of Article 20 of these regulations.
Article 22 engaged in the production of Class II, Class III medical devices, the manufacturer shall apply to the local food and drug supervision and management department of the people's government of the provinces, autonomous regions and municipalities directly under the Central Government for production authorization and submit its compliance with the conditions of the provisions of Article 20 of the Ordinance, as well as the production of medical devices, the registration certificate.
Acceptance of applications for production authorization of food and drug supervision and management department shall accept the application within 30 working days from the date of application for review, in accordance with the State Council food and drug supervision and management department to develop the requirements of the quality management standard for the production of medical devices for verification. Meet the requirements of the conditions, and issued a permit and medical device production license; do not meet the requirements of the conditions, not licensed and the reasons in writing.
Medical device manufacturing license is valid for five years. The expiration of the validity of the need for continuation, in accordance with the provisions of the relevant administrative licensing law for continuation procedures.