NMPA issued 28 draft guidelines on October 18 for feedback. The guidelines cover one class III device, 27 class II devices and IVDs (cardiovascular, gastroenterological, urological, dental, gynecological and pediatric products), and manufacturing methods. Feedbacks need to be submitted by November 17.

What are the 28 Guidelines

If your device involves the following guidelines, please contact us so we can translate the guideline(s) for you. info@ChinaMedDevice.com.

Class III device:

• Registration Guideline on Balloon Catheter (draft)

Class II devices:

• Registration Guideline on Disposable Medical Rinse Product (draft)
• Registration Guideline on Non-absorbable Surgical Sutures (draft)
• Registration Guideline on Furrow Sealant (draft)
• Registration Guideline on Heat and Humidity Exchanger (draft)
• Registration Guideline on Pediatric Devices (draft)
• Registration Guideline on Low Frequency Galvanometer (draft)
• Registration Guideline on Ureteral Stent (draft)
• Registration Guideline on Electric Pneumatic Hemostatic Apparatus (draft)
• Registration Guideline on Pulmonary Function Test Apparatus (draft)
• Registration Guideline on Disposable Sterile Vaginal Dilator (draft)
• Registration Guideline on Medical Carbon Dioxide Incubator (draft)
• Registration Guideline on Uterine Salpingography Balloon Catheter (draft)
• Registration Guideline on Transnasal Nutrition Tube Products (draft)
• Registration Guideline on Dental Film Type Orthotics (draft)
• Registration Guideline on Shockwave Therapeutic Instrument (draft)
• Registration Guideline on Hot Compression Bag (draft)
• Registration Guideline on Audiometer (draft)
• Registration Guideline on Dental Phosphate Etchant Products (draft)

Class II IVDs:

• Registration and Labeling Guideline on Domestic-Use IVDs (draft)
• Registration Guideline on Prolactin Detection Reagent (draft)
• Registration Guideline on Determination of Serum Amyloid A Reagent (draft)
• Registration Guideline on Rheumatoid Factor Assay Reagent (draft)
• Registration Guideline on Total Triiodinic Thyroproline Assay Reagent (draft)
• Registration Guideline on Determination of 25-Hydroxyvitamin D Reagent (draft)
• Registration Guideline on Specific Protein Immunoanalyzer (draft)

Manufacturing methods:

• Registration Guideline on Reprocessing Instructions and Validation Methods for Reusable Medical Devices (ii) (draft)
• Registration Guideline on Shelf Life Validity of Sterile Medical Device Container and Seal System (draft)

What are the Implications

Whether you are renewing or submitting new registration, your medical devices and guidelines need to meet these new guidelines. Even if your renewals (every 5 years required by NMPA) have no changes, you still have to prove that your originally approved products can meet the new guidelines. As a result, your originally approved products will still need to go through local type testing to show that you are current with the new guidelines. ChinaMed Device, LLC has test engineers at NMPA testing centers to help you assess and expedite your type testing needs and shorten your renewal or new approval time. info@ChinaMedDevice.com.

NMPA announced the “2019 Medical Device Registration Guidelines Revision Plan” on February 25, in which 86 medical devices, IVDs and manufacturing methods are included.

Revision of more than 300 industry standards for medical devices, IVDs and quality systems could be expected by the end of 2020, NMPA announced in January 2018.

For slides of “2019 NMPA Regulatory Updates” that we shared at RAPS Convergence, please email us at info@ChinaMedDevice.com.

To keep up to date on NMPA (CFDA) changes, please opt in our monthly newsletter https://ChinaMedDevice.com/cmd-blogs/

About ChinaMed Device, LLC

ChinaMed Device, LLC (www.ChinaMedDevice.com) provides regulatory and commercialization turnkey solutions for medical device, IVD, CDx and combination products in China. As a qualified NMPA (CFDA) legal agent with offices in Boston and Beijing, we can represent manufacturers for the complete product life cycle without their need to create a local entity in China. Our NMPA (CFDA) regulatory services include strategy, registration, local type testing, product technical requirement (PTR), clinical evaluation report (CER), clinical trial, GMP and post-market surveillance (AE, recall, inspection, etc.). Our commercialization services include market research, reimbursement, partnership strategy and distribution qualification.