CFDA issued 27 device guidelines on Oct.8^th, covering benefit-risk assessment, cardiovascular, urology and orthopedic devices and immune oncology IVDs, etc.

Whether you are renewing or doing new registration, your medical device/IVD will need to meet these new guidelines/standards. Even if your renewal (every 5 years required by CFDA) products have no changes, you still have to prove that your originally approved products from before will meet the newly-imposed requirements.  As a result, your originally approved products will need to go through type testing to show that you are up to date with the guidelines/ standards. China Med Device, LLC has onsite test engineers to help you assess and expedite your type testing needs to shorten your renewal or new approval time.

1. Guideline on Medical Device Benefit-Risk Assessment
2. Technical Review Guideline on Disposable Heart Fixation Device
3. Technical Review Guideline on Colloidal Gold Immunochromatography Analyzer
4. Technical Review Guideline on Follicle Stimulating Hormone Detection Reagent
5. Technical Review Guideline on Limb Compression Therapy Equipment
6. Technical Review Guideline on Direct Ophthalmoscope
7. Technical Review Guideline on Stone Retrieval Basket
8. Technical Review Guideline on Nasal Bile Drainage Tube
9. Technical Review Guideline on X-Ray Tube Assembly
10. Technical Review Guideline on Biofeedback Therapy Device
11. Technical Review Guideline on Disposable Cervical Dilatation Balloon Catheter
12. Technical Review Guideline on Dental Drill
13. Technical Review Guideline on Sterilization for Sterile Medical Device
14. Technical Review Guideline on Antibody Detection Reagent
15. Technical Review Guideline on Simple Respirator
16. Technical Review Guideline on Total Bile Acid Assay Kit
17. Technical Review Guideline on Passive and Assistive Range of Motion (ROM) Exercise Device
18. Technical Review Guideline on Disposable Endoscopic Biopsy Forceps
19. Technical Review Guideline on Dental Impression Material
20. Technical Review Guideline on Plasma Freezer
21. Technical Review Guideline on Suture Needle
22. Technical Review Guideline on Glycosylated Albumin Assay
23. Technical Review Guideline on Enteral feeding pump
24. Technical Review Guideline on Root Tip Locator
25. Technical Review Guideline on Anti-Thyroid Peroxidase Antibody Assay Kit
26. Technical Review Guideline on Creatinine Assay Reagent
27. Technical Review Guideline on Urinary Dynamics Analyzer

For official Chinese link of the guidelines, please email info@ChinaMedDevice.com.

Please email us the guideline you are interested in, we can find it for you.

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About China Med Device, LLC

China Med Device, LLC (www.ChinaMedDevice.com), a Boston headquartered company, provides regulatory and commercialization turnkey solutions for western medical device, IVD and combination-product companies to enter China. Our NMPA (CFDA) regulatory services include: regulatory strategy, RA, clinical evaluation, clinical trial, QA, GMP and post-market compliance. Our commercialization services include: market assessment research, reimbursement, partnership, distribution qualification and management. We are a NMPA (CFDA) certified legal agent. With offices in Boston and Beijing, we can service our clients 24/7.