I. Medical Device Supervision and Administration Regulations" promulgated on April 1, 2000, "Medical Device Supervision and Administration Regulations" promulgated, the beginning of the statutory form of medical device registration management. On April 10 of the same year, the former State Drug Administration to the 16th Bureau Order promulgated the "Registration of Medical Devices", the registration number is arranged as follows: X1 drug control device (X2) word XXXX3 X4XX5XXXXX6th. Where:
X1 for the registration of the abbreviation of the location of the institution (country or province, autonomous region, municipality directly under the Central Government, or province, autonomous region + municipalities);
X2 for the form of registration (trial, quasi, into). Class I medical devices to implement direct quasi-production registration. Class II and Class III medical devices first for trial production registration. Trial production registration after the seventh month, you can apply for quasi-production registration, into the form of registration for foreign enterprises;
XXXX3 for the year of registration;
X4 for the product management category X;
XX5 for the product trial production period termination year (trial production registration) or product variety code (quasi-production registration); XXXXX6 for the registration of the number of running water.
such as the domestic 2001 registration of single-use sterile syringes registration number is arranged in the form of "State Drug Administration equipment (quasi) word 2001 No. 315 XXXX"
Two. State Food and Drug Administration was established. June 13, 2003, the State Food and Drug Administration issued "on the revision of the medical device registration certificate number notice" (State Food and Drug Administration Measures [2003] No. 98), the medical device registration certificate number corresponding to the following adjustments:
From the original X 1 Drug Administration Measures (X2) word XXXX3 No. X4 XX 5XXXXX6 changed to X1 Food and Drug Administration Machinery (X2) word XXXX3 No. X4 XX 5 XXXX6. This adjustment applies to the registration certificate issued by the State Food and Drug Administration from June 20th. For example, in July 2003, the domestic registration of single-use sterile syringes registration number by the original "State Drug Administration equipment (quasi) word 2003 No. 315 XXXX" to "State Food and Drug Administration equipment (quasi) word 2003 No. 315 XXXX".
From this stage onwards, the "State Drug Administration Equipment" in the way the registration numbers issued by the State Bureau are organized is always changed to "State Food and Drug Administration Equipment".
Three. State Food and Drug Administration, "Medical Device Registration Management Measures" promulgated. August 9, 2004, the State Food and Drug Administration issued Bureau Order No. 16, "Medical Device Registration Management Measures". At this time, the arrangement of medical device registration number changed to: X (X) 1 (Food) Drug Supervision and Measures (X2) word XXXX3 No. X4XX5XXXXXX6. Where:
X1 is the abbreviation of the location of the registration and approval department. Within the third class of medical devices, overseas medical devices and medical devices in Taiwan, Hong Kong, Macao for the "country". Within the second class of medical devices for the registration and approval department of the province, autonomous region, municipality directly under the Central Government abbreviation. Domestic Class I medical devices for the registration and approval department of the province, autonomous region, municipality directly under the Central Government for short plus the short name of the municipal administrative region, XX1 (no corresponding municipal administrative region, only for the province, autonomous region, municipality directly under the Central Government for the short name);
X2 for the form of registration (permitted, into the permit, permit). The word "permit" applies to medical devices within the country. The word "into" applies to foreign medical devices. The word "permit" applies to medical devices in Taiwan, Hong Kong and Macao;
XXXX3 is the year of approval for registration;
X4 is the product management category;
XX5 is the product variety code;
XXXX6 is the registration number.
For example, in September 2004, the domestic quasi-registered production of single-use sterile syringes registration number is arranged in the form of "state (food) drug supervision and mechanical (quasi) word 2004 No. 315 XXXX"
Beginning from this period, the medical device products to cancel the trial registration, that is, the territory of the product is only quasi-production registration A form of medical device registration issued by the local bureau of the review of the medical device registration certificate number also all to "× (×) 1 (food) drug supervision, mechanical" at the beginning.
Classification of reagents (on in vitro diagnostic reagents standardized management of a number of issues)
In order to strengthen the in vitro diagnostic reagents standardized management and use of in vitro diagnostic reagents in the choice of in vitro diagnostic reagents, first of all, we need to clarify the classification of the in vitro diagnostic reagents:
One of the management of in vitro bio-diagnostic reagents according to the drugs include:
1. blood, tissue mating reagents (eg. Blood bank for the identification of ABO blood type anti-A, anti-B standard serum; identification of Rh blood type anti-D serum, etc.).
2. microbial antigen, antibody and nucleic acid detection reagents (such as immunization room commonly used enzyme assay and gold standard detection of hepatitis B two-half reagents, hepatitis C, AIDS, syphilis detection kits; PCR, etc.)
3. Tumor marker reagents (such as commonly used AFP, CEA, etc.)
4. Immunohistochemistry and human tissue cell reagents
5. 5. human genetic testing reagents
6. biochip class
7. allergy diagnostic reagents
2, in vitro diagnostic reagents managed by medical devices, including:
1. Clinical basic test reagents (such as blood cell analyzers supporting reagents, on the urinalysis machine urine strips, pregnancy strips, occult blood and other clinically commonly used reagents)
2. clinical chemistry reagents (such as commonly used AFP, CEA, etc.)
3. p>2. clinical chemistry reagents (e.g. on-line or manual biochemistry reagents used in biochemistry laboratory)3. blood gas, electrolyte determination reagents
4. vitamin determination reagents
5. cell histochemistry staining reagents
6. autoimmune diagnostic reagents
7. microbiology test reagents
Additionally, it is important to know the legitimacy of the supplier. In addition, to understand the legitimacy of the supplier, the supplier is required to provide the following qualification documents:
(a) the supplier's medical device license (pay attention to check the scope of permitted to operate several types of devices)
(b) the supplier's pharmaceutical license (pay attention to check the presence of diagnostic drugs)
(c) the supplier's business license
(d) the manufacturer of the products provided by the manufacturer of the reagents
(e) the supplier's license to operate the products. (D) the medical device or drug production license of the manufacturer of the product provided (a medical device production license is required for diagnostic reagents that are medical devices; a drug production license is required for diagnostic drugs that are diagnostic drugs.)
(e) the production approval number of the product provided (belonging to Class III medical devices, must be the State Food and Drug Administration Equipment (quasi) × × × × No.; belonging to Class I and Class II medical devices, by the provinces or municipalities under the jurisdiction of the Food and Drug Administration approved by the provincial or municipal food and drug administration of the × × × Provincial or municipal food and drug Administration Equipment (quasi) word (or) the word × × × × × × font size; if it is an imported product, you must provide the import certificate; belonging to the drug, it must be the State Food and Drug Administration (quasi) font size. (quasi) font size.
(F) the products supplied by the manufacturer to the supplier's authorization.
(vii) the supplier club to the sales staff of the authorization.
Copies of the above documents need to be stamped with the supplier's seal