Medical Device Registration

PHDS in Medical Device Registration in China

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Phase and Time for Registration Process of Medical Devices

The whole registration process of a medical device product contains four phases:

1.      To prepare the technical materials and draft product technical standard;

2.      To conduct clinical trial or verification;

3.      To conduct type test;

4.      To inspect, technical evaluate the completely set materials for product registration and then approve the application.


The reference time of them is:


Phase 1: Preparation of technical materials as well as standard written is entirely operated by the applicant of product registration (such as domestic and foreign manufacturers) and its authorized registration agent. Therefore, the cycle length depends entirely on the exchange and communication between the two sides.

Phase 2: The time of clinical trials with high techniques and complex operations depends more entirely on the applicants of product registration. Based on experience, it normally takes at least 3 calendar months for domestic products and no less than 6 calendar months for foreign products.

Phase 3: The type test for product registration is conducted by Medical Device testing institutions accredited by SFDA. About the time, it is not clearly defined. However, it usually takes at least 3 calendar months based on experience.

Phase 4: Chinese regulatory authorities spend within 30 working days for Class I Medical Device, 60 working days for Class II Medical Device and 90 working days for Class III Medical Device respectively, in deciding if the product can be registered in China. For foreign products, it is 90 working days generally. Moreover, in the course of review of registration applications, the time for testing, expert review and hearing does not count within the period specified above. However, the corresponding authority for technical evaluation spends no more than 45 working days for review after receiving the integrate supplemented materials required.

Therefore, based on product classification, domestic or foreign, IVD reagent or not, placing into market or not, the whole cycle is different absolutely. A good example is the more advanced new products. Once the risk and effectiveness of this product is difficult to determine, the technical evaluation authority authorized by CFDA can organize experts to review and hearings. The corresponding time does not count within the time limit. Thus, it is impossible to clarify the specific cycle length.

Classification of Medical Devices in China

According to SFDA Notice [2007]229 "Management Method of In Vitro Diagnostic Reagents Registration (Interim)" taken effect as of June 1, 2007, IVD reagents regulated as medical devices are classified into Class I, II, or III according to the product risk level from low to high in turn.

Class III Medical Device: Highest Risk

Reagents used in relation to:

1.      Test of pathogenic antigen, antibody and nucleic acid;

2.      Blood type and tissue typing;

3.      Test of human genes;

4.      Hereditary diseases;

5.      Test of anesthetic, psychiatric drug and toxic medicine for medical purpose;

6.      Test of drug target;

7.      Test of tumor marker;

8.      Allergic reaction (allergen)

Class II Medical Device: Medium risk

Apart from Class III and Class I products, others fall into Class II products, which mainly include the following reagents detected:

1.      Proteins;

2.      Glucide;

3.      Hormones;

4.      Enzymes;

5.      Esters;

6.      Vitamins;

7.      Inorganic ions;

8.      Drugs and their metabolic by-products;

9.      Autologous Antibody;

10.    Microbes Identification (except pathogens) and Drug allergic assays;

11.    Other physiological, biochemical and immune function indicators

Class I Medical Device: Lowest risk

Reagents used in relation to:

1.      Microbe Culture medium (excluding for microbe identification and drug allergic assay);

2.      Sample treatment, such as hemolytic reagents, dilution solutions and stain solutions.

Major Regulations

Regulations for the Supervision and Administration of Medical Devices