Record number of Guidelines and Standards announced by NMPA in November

NMPA published unprecedented number of medical device regulations in November, including 21 final guidelines, 14 draft guidelines for feedback and 19 final industry standards.

Generic Guidelines

Among those are three generic guidelines:

1. Technical Guideline on Risk-Benefit Assessment of Medical Device
2. Technical Guideline on Registration Submission Documents during Supplement Phase (Draft)
3. Technical Guideline on Modification for In Vitro Diagnostics (Draft)

We have translated the Technical Guideline on Risk-Benefit Assessment of Medical Device. For an English copy, please email info@ChinaMedDevice.com. We will send it to you with a nominal fee.

For our comments on Technical Guideline on Registration Submission Documents during Supplement Phase (Draft), please click HERE.

Implication on Registration & Renewal

Whether you are renewing or submitting new registration, your medical devices need to meet these new guidelines and standards. 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 requirements. As a result, your originally approved products will still need to go through local type testing to show that you are current with them.

China Med 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.

Full List

Below is the full list of guidelines & standards in November.

Final Guidelines:

1. Technical Guideline on Risk-Benefit Assessment of Medical Device
2. Registration Guideline on Embryo Transfer Catheter for Assisted Reproduction
3. Registration Guideline on Verification and Validation of Known Leachables for Medical Devices
4. Registration Guideline on Circulation Pipe in Cardiopulmonary Bypass System
5. Registration Guideline for Human Chromosomal Abnormality Detection Reagents Based on Cell Fluorescence In Situ Hybridization
6. Registration Guideline for Respiratory Virus Multiple Nucleic Acid Detection Reagents
7. Registration Guideline for Staphylococcus Aureus and Methicillin-Resistant Staphylococcus Aureus Based on Nucleic Acid Detection Methods
8. Registration Guideline on Nucleic Acid detection reagents for Chlamydia trachomatis and / or Neisseria gonorrhoeae
9. Registration Guideline the Amino Acid, Carnitine, and Succinylacetone Detection Reagents
10. Registration Guideline on Limb Compression Physiotherapy Equipment
11. Registration Guideline for Technical Review of Ophthalmoscope
12. Registration Guideline for Medical Diagnostic X-ray Tube Assembly registration
13. Registration Guideline for Electromyography Biofeedback Therapy Instrument
14. Registration Guideline for Dental Implant Surgery Drill
15. Registration Guideline for Artificial Resuscitator Registration
16. Registration Guideline for Active and Passive Rehabilitation Equipment for Upper and Lower Limbs
17. Registration Guideline for Single-Use Endoscopic Biopsy Forceps
18. Registration Guideline for Plasma Freezer
19. Registration Guideline for Intestine Nutrition Pump
20. Registration Guideline for Apex Locator
21. Registration Guideline for Urodynamic Analyzer

Draft Guidelines for Feedback:

1. Technical Guideline on Registration Submission Documents during Supplement Phase (Draft)
2. Registration Guideline on 3D Printed Spinal Fusion Cage (Draft)
3. Registration Guideline on Hemodialysis Equipment (Draft)
4. Technical Guideline on IFU for Domestic-Use Medical Devices (Draft)
5. Registration Guideline on Fundus Camera (Draft)
6. Registration Guideline on Implantable Left Ventricular Assist System (Draft)
7. Registration Guideline on Laughing Gas Inhalation Analgesic Device (Draft)
8. Registration Guideline on X-Ray Image Guidance System for Radiotherapy (Draft)
9. Registration Guideline on Positron Emission / X-Ray Computed Tomography System (Draft)
10. Technical Guideline on Evaluation of Fatigue Performance of Biological Femoral Stem and Handle (Draft)
11. Technical Guideline on Modification for In Vitro Diagnostics (Draft)
12. Registration Guideline on Dengue Virus Nucleic Acid Detection Reagent (Draft)
13. Registration Guideline on Mammography X-ray system (Draft)
14. Guideline on Medical Device Animal Study Part 2: Trial Design, Implementation of Quality Assurance (Draft)

Final Industry Standards:

1. YY / T 0681.15-2019 Sterile Medical Device Packaging Test Methods-Part 15: Performance Testing of Transport Containers and Systems
2. YY / T 0681.17-2019 Test method for packaging of sterile medical devices Part 17: Microbial Barrier Test by Aerosol Filtration Method of Breathable Packaging
3. YY / T 0719.8-2019 Ophthalmic Optics Contact Lens Care Products Part 8: Methods for Measuring Detergents
4. YY / T 1624-2019 Manual Negative Pressure Cupping Device
5. YY / T 1638.1-2019 Patient Transport Equipment Part 1: Ambulance Stretcher
6. YY / T 1646-2019 Dentistry Test Method for X-ray Blocking Resistance of Materials
7. YY / T 1647-2019 Joint Replacement Implants Shoulder Joint Prosthesis Static Shear Evaluation Test Method for Glenoid Locking Mechanism
8. YY / T 1649.2-2019 Test for Interaction between Medical Devices and Platelets Part 2: Determination of In Vitro Platelet Activation Products (β-TG, PF4 and TxB2)
9. YY / T 1672-2019 Pepsinogen I / II Assay Kit
10. YY / T 1673-2019 Amphetamine Testing Kit
11. YY / T 1674-2019 Insulin-Like Growth Factor I Assay Kit
12. YY / T 1675-2019 Serum Electrolyte (potassium, sodium, calcium, magnesium) Reference Measurement Procedure (Ion Chromatography)
13. YY / T 1677-2019 Assay Kit for Vitamin B12 (Labeled Immunoassay)
14. YY / T 1678-2019 Method for Detecting Molecular Weight and Molecular Weight Distribution of Polylactic Acid and Copolymers Thereof for Surgical Implants
15. YY / T 1682-2019 Ureaplasma / Mycoplasma Hominis Culture and Drug Sensitivity Test Kit
16. YY / T 1683-2019 Dental Surgery
17. YY / T 1687-2019 Boiling Sterilizer
18. YY / T 1689-2019 Dental Surgery
19. YY/T 0953-2015 Medical Carboxymethyl Chitosan

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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.