Imported Class I medical devices for the record, the filer to the State Food and Drug Administration to submit the record information. Hong Kong, Macao, Taiwan, the filing of medical devices, with reference to the import of medical devices.
Expanded Information:
Class I medical devices are those whose safety and efficacy are sufficiently assured through routine management.
Introduction:
According to Article 5 of the "Regulations for the Supervision and Administration of Medical Devices", the state implements classified management of medical devices.
Catalog:
Catalog of Medical Devices
Basic Surgical InstrumentsMicrosurgical Instruments
Neurosurgical InstrumentsOphthalmic Instruments
Ear, Nose & Throat Surgical InstrumentsOrthodontic Instruments
Thoracic and Cardiovascular Surgical InstrumentsAbdominal Surgical Instruments
Urological Instruments Anorectal Surgery InstrumentsOrthopedic Surgery (Orthopedic) Surgical Instruments
Obstetrics and Gynecology Surgical InstrumentsFamily Planning Surgical Instruments
Injectable and Puncture InstrumentsBurns (Orthopedic) Surgical Instruments
Preparatory Diagnostic InstrumentsMedical Electronic Instruments
Medical Optical Apparatus, Instruments and Endoscopic DevicesMedical Ultrasonic Instruments and Related Equipment
Medical Laser instruments and equipment Medical high-frequency instruments and equipment
Physical therapy and rehabilitation equipment Chinese medicine instruments
Medical magnetic **** vibration equipment medical X-ray equipment
Medical X-ray accessory equipment and components medical high-energy radiation equipment
Medical nuclide equipment medical ray protection supplies, devices
Clinical test and analysis instruments medical laboratory and basic equipment apparatus
Extracorporeal circulation and blood processing equipment implantable materials and artificial organs
Operating room, emergency room, diagnostic and treatment room equipment and appliances stomatology equipment and appliances
Ward care equipment and appliances? Disinfection and sterilization equipment and apparatus
Medical cold therapy, cryogenic, refrigeration equipment and apparatus? Dental materials
Medical hygiene materials and dressings medical suture materials and adhesives
Medical polymer materials and products interventional devices
For the record:
(a) medical device filing refers to the food and drug supervision and management department of the medical device filing (hereinafter referred to as the filing of medical device filing information submitted to the record of the first class of medical devices archived for inspection.
(b) the implementation of the record of medical devices for the first class of medical devices catalog and the corresponding in vitro diagnostic reagents classified subdirectory of class I medical devices.
Domestic Class I medical device filing, the filing of municipal food and drug supervision and management departments to submit the record information. Imported Class I medical devices for the record, the filer to the State Food and Drug Administration to submit the record information. Hong Kong, Macao, Taiwan medical equipment for the record, with reference to the import of medical devices.
(C) for the record of imported medical devices, should be filed in the filer's place of registration or production address in the country (region) to obtain marketing authorization for medical devices.
The filer's place of registration or production address in the country (region) is not the product as a medical device management, the filer is required to provide relevant documents, including the filer's place of registration or production address in the country (region) to authorize the product is legally listed on the market for sale of documents.
(d) overseas filers for the record of imported medical devices, should be established in China through its representative organizations or designated as an agent of the enterprise legal person in China.
(E) the filer shall prepare to record the medical device product technical requirements. Product technical requirements mainly include performance indicators and test methods for finished medical devices.
(F) for the record of medical devices, the filer should be in accordance with the relevant requirements (see Annex 1) to submit the filing information, and the filing of information on the authenticity of the authenticity, completeness, compliance is responsible.
(vii) the record information meets the requirements, the food and drug administration shall be filed on the spot. Record information is incomplete or does not meet the required form, it should be informed of the need to make corrections to all the contents. Not for the record, should inform the filer and explain the reasons.
(viii) to be filed medical devices, food and drug supervision and management departments should be in accordance with the relevant requirements of the format of the record voucher (see Annex 2), and will be filed in the information table (see Annex 3) in the information contained in its website to be published. Food and drug supervision and management departments in accordance with the first class medical device filing operation specification (see Annex 4) to carry out the filing work. The filer shall mark the filing number in the instructions and labeling of medical devices.
(ix) has been filed medical devices, filing information on the content of the table and the filing of the product technical requirements for the record changes, the filer should be submitted to the change in the description of the situation and the relevant documents, to the original filing department to change the filing information. Food and Drug Administration for the record information in line with the formal requirements, should be set out in the change of circumstances in the change of circumstances, the record information on file.
(J) the first class of medical devices filing number is organized as follows:
×1Mechanical preparation ××××2××××3 number.
Which:
×1 for the record of the department of the location of the abbreviation:
Imported Class I medical devices for the "country";
International Class I medical devices for the record of the department of the province, autonomous regions, municipalities directly under the central government for the abbreviation of the municipal administrative region where the city-level administrative region of the abbreviation (no). The corresponding municipal administrative region, only the province, autonomous region, municipality directly under the Central Government for the abbreviation);
××××2 for the record year;
××××3 for the record running number.
Implementation time
The Regulations for the Supervision and Administration of Medical Devices (Decree No. 650 of the State Council) came into force on June 1, 2014 onwards. According to the regulations, the first class of medical devices to implement product filing management.
Source: China Medical Device Information Network