BeiJing DYS Medical Consulting Co., Ltd. is a professional consulting company, who focuses on China CFDA registration for imported medical devices. All of our registration specialists have more than 5 years experience of CFDA registration.

We can provide One-Stop & Comprehensive Service for CFDA registration of Imported Medical Devices. We have get many CFDA Certificates for more than 50 manufacturers.

We keep good relationship with CFDA and the testing centers, and understand the latest regulations, so we can ensure efficient registration.

Registration documents list For Class I
1. ISO 13485 Certificate;
2. Marketing Certificate, for example Free Sale Certificate issued by Ministry of Health in Pakistan, 510k Letter and CTFG in USA, CE Certificate and CE DOC in Europe;
3. Risk Management Report;
4. Dimensions and raw materials for every model;
5. Manufacturing Flow Chart;
6. Numbers of employee and Area of the factory;
7. Label for minimum sale unit;
8. Technical Requirements;
9. Self-test Report;
10. Statement of Testing Typical Models;
11. Clinical evaluation;
12. Instruction for use or Statement of non-IFU;
13. Letter of authorization for Agent;
14. Conformance Statement.
For the documents in yellow, we will provide the templates, you only need sign and notarize them.
For other documents, you need prepare them by yourself, and we also can assist you to prepare them.

Registration documents list for Class II & III
1. ISO 13485 Certificate;
2. Marketing Certificate, for example Free Sale Certificate issued by Ministry of Health in Pakistan, 510k Letter and CTFG in USA, CE Certificate and CE DOC in Europe;
3. Risk Management Report;
4. List of Basic Requirements for Safety and Effectiveness of Medical Device;
5. Sterilization and Disinfection Studies(if have);
6. Shelf-life and Package Studies;
7. Animal Studies(if have);
8. Dimensions and raw materials for every model;
9. Manufacturing Flow Chart;
10. Numbers of employee and Area of the factory;
11. Label for minimum sale unit;
12. Technical Requirements;
13. Statement of Testing Typical Models;
14. Clinical evaluation;
15. Instruction for use or Statement of non-IFU;
16. Letter of authorization for Agent;
17. Conformance Statement.

Cases Class I

1. Carl Martin in Germany: about 50 CFDA Certificates for Surgical Instruments;
2. Alloyed in Germany: about 60 CFDA Certificates for Surgical Instruments;
3. AGILE in Pakistan: about 15 CFDA Certificates for Oral Surgical Instruments;
4. MEDESY in Italy: Oral Surgical Instruments;
5. Siam Sempermed in Thailand and SUPERMAX Gloves in Malaysia: Examination Gloves;
6. ROYAX in Czech: Several Stretchers；
7.OSUNG in Korea: 20 groups Class 1 medical devices;
8.Snucone in Korea: Dental drills, and 7 groups Class 1 medical devices;
9.Melpex in Pakistan: 4 groups Class 1 medical devices;
10.Schnell in Pakistan: 10 groups Class 1 medical devices;
11.Sawuat in Pakistan: 2 groups Class 1 medical devices;
12.FFDM in USA: Dental Burs, and 4 groups Class 1 medical devices;
13. ......

Cases Class II & III

1. BORCAD in Czech: Birthing Bed and Gynecological Chair;
2. SS WHITE in USA: Carbide Burs, Diamond Burs, Plastic Burs;
3. BASIC DENTAL IMPLANTS in USA: Dental Implants, Drills, Implants Instruments;
4. APIXIA in USA and DENTAMERICA in USA: Scalers, Endodontic Handpieces, Curing Lights, Digital Dental Radiography System;
5. MEDICA in USA: many IVDs and Clinical Analyzers;
6. Ivoclar Vivadent in Liechtenstein: Polishing pastes, Etching gels, Adhesives, Rubber Dams, Fluor Protector, Resins, Impression Materials, Fiber-post system, Sealants, Whitening Gels, Alloys, Knitted Cord, Desensitizing Agents, Polypropylene Coping Sheets, Cements;
7. VDW in Germany: Surgical Units, Endodontic Handpieces, Motors, Guttapercha Fillers;
8. CPR in Germany: SICO Condoms;
9. BIODENT in Korea: Irrigating Needles, Injection Needles;
10. SPES in Italy: Surface Electrodes, Electromyography Needle Electrodes, Stimulating and Recording Electrodes;
11.Scientific Pharmaceuticals in USA: Etching Gel, Bonding agent, Cavity Liner, Temporary Filling Material etc.;
12. ......

DYS provides professional translation services for several languages, including English, Japanese, Korean, German and Italian. Our translators are employed through rigorous entrance examinations, and regularly participate in the company's training courses.  They have not only excellent language skills and translation skills, but also have extensive experience in translating medical documents.  We follow a standard translation process, rigorous review criteria and a translation quality control system, to ensure that customers are  provided with quality translation services.

Advantaged Translation Range
1.Translation of CFDA regulations;
2.Translation of internal technical data of manufacturers
3.Translation of domestic and foreign standards and test reports

Translation Process