Bryan Gilburg - China

“These new Standards are being implemented differently. Please confirm what new Standards apply to your device(s) in China and get testing arranged right away.”

Bryan Gilburg

Managing Director

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China NMPA Updates Compulsory Standards for Medical Devices

Published on: December 7th, 2022

Change Applications Required to Maintain Compliance 

On November 18th, 2022, the China NMPA released updated medical device compulsory standards covering a wide variety of medical devices, a list of which can be found on the National Institute for Food and Drug Control here and a spreadsheet of updated standards here. While the NMPA often releases new standards for medical devices, the recent update is particularly comprehensive, with nearly every kind of device affected in the next year. Between this update from the NMPA and their recent electro-medical safety update, (more information on that can be found here), it is absolutely imperative for manufacturers marketing products in China to stay informed of which standards are changing so they can take immediate action to comply with the new requirements.  

Depending on the specific update, manufacturers will need to submit a change notification to show compliance. In the past, manufacturers could account for any applicable Standards changes in the International Medical Device Certificate (IMDRC) renewal application (note: an IMDRC is valid for five years). However, now they must be addressed via a Change Notification prior to the submission of a renewal application. This is a new treatment that adds significant time to the renewal process, creating another element that must be accounted for by the manufacturer in order to maintain compliance.  

Timeline and Standards Testing Information

Change Applications require anywhere between 7 and 12 months for approval while renewal applications must be submitted at least 6 months prior to their expiration. Given these timelines, manufacturers should determine whether in country testing to new standards is required for their products immediately. Additionally, in order to demonstrate compliance to a Standard, the manufacturer must obtain a test report from a qualified test laboratory in China, which will necessitate additional time before the renewal can take place. This year, these tests are eligible to be performed by a qualified third-party test laboratory. Lastly, manufacturers that submit a renewal application 6 months before the expiration and found to not meet the new standards can resubmit their renewal application once their Change Application has been approved. Otherwise, manufacturers that submitted their renewal applications within 6 months of the renewal date are unable to resubmit their application if compliance issues are found and will need to submit a new application, requiring significantly more time and money.

Note: Renewal applications for products not compliant with new standards will not be issued until change application is processed, potentially causing market interruption. 

Processing the new Standards requirements can be as complicated as it is crucial. Manufacturers are heavily advised to work closely with their agents in China to confirm if and how their IMDRCs will be impacted. The regulatory experts at Asia Actual China are available to help ensure market access for your medical devices. Please contact us if you’d like our assistance determining if any of your products are affected by these new standards. 

Updated Compulsory Standards by Product Type  

These new requirements have varying implementation dates with some starting in 2022 and many being implemented on May 1, 2023 and moving forward to May 2024 and 2025. Manufacturers will have to make sure they have updated documentation showcasing that their products are in accordance with the new requirements. Additionally, as the NMPA continues to update their standards, these standards may be updated once again in 2023. Manufacturers and regulatory professionals should stay informed of the continuously changing regulations in China. Asia Actual will continue to monitor the situation closely and will report on any changes in our newsletter and on LinkedIn. 

New or Updated Compulsory Standards in China 

Below is an abbreviated list of new standards and their implementation dates. Click here for the entire list to look for a specific product type/category.  This spreadsheet has the full list, as well as a pivot table for reviewing the standards by implementation date and primary product category.

Blood separation, processing and storage equipment  

  1. Disposable pump blood transfusion set (June 1st, 2022)  
  2. Disposable Blood Bags, Disposable Blood Component Collection Bags & Disposable Plasma Bags (Part 1, Feb. 1st 2022, Part 4, June 1st, 2023) 

Keratometer (January 1st, 2022) 

Diagnostic X-Ray Machine (May 1st, 2023) 

  1. Angiographic X-ray machine 
  2. Dental X-Ray 
  3. Perspective photography X-ray machine 
  4. Mobile C-arm X-ray machine 
  5. Vehicle X-ray machine 

High Intensity Ultrasound Therapy Equipment (May 1st, 2023) 

  1. Ultrasonic Therapy Apparatus, Ultrasound Therapy System, Focused Ultrasound Therapy System for Fat Reduction 
  2. MRI-guided high-intensity focused ultrasound therapy system 
  3. Tumor Ablation Focused Ultrasound Therapy System, Tumor Focused Ultrasound Therapy System, Tumor High Intensity Focused Ultrasound Therapy System 

ECG (Electrocardiograph) (May 1st, 2023) 

Radiation Therapy (May 1st, 2023, May 1st, 2024, & May 1st, 2025)

Respiratory Equipment 

  1. Intensive care unit ventilators (life support) (May 1st, 2023) 
  2. Household ventilators (life support) (May 1st, 2024) 
  3. Sleep apnea therapy equipment (May 1st, 2024) 

Anesthesia Equipment 

  1. Anesthesia system, anesthesia machine (May 1st, 2024) 

First Aid Equipment 

  1. External defibrillation equipment (August 1st, 2024) 
  2. Baby incubator (May 1st, 2023) 
  3. Baby radiant warmer (May 1st, 2024) 

Electrotherapy equipment/apparatus (May 1st, 2023) 

  1. Interference Electrotherapy Apparatus 
  2. Nerve and Muscle Stimulators 
  3. Internal Electrodes for Nerve and Muscle Stimulators, Surface Electrodes for Nerve and Muscle Stimulators 

Phototherapy Equipment (May 1st, 2023) 

  1. Photodynamic laser therapy equipment 
  2. Photodynamic therapy equipment 
  3. Intense pulsed light therapy equipment 
  4. Red light therapy equipment 
  5. Blue light therapy equipment 
  6. Ultraviolet therapy equipment 

Blood purification and peritoneal dialysis equipment (May 1st, 2023) 

  1. Hemodialysis equipment, hemodiafiltration equipment 
  2. Continuous blood purification equipment 
  3. Hemoperfusion machine 
  4. Artificial liver equipment 
  5. Blood pump 
  6. Peritoneal dialysis machine 
  7. Blood lipid separation equipment 

Injection and puncture instruments (May 1st, 2023) 

  1. Syringe pump  

Intravascular infusion devices (May 1st, 2023) 

  1. Infusion pump  

Ophthalmic Laser Therapy Equipment (May 1st, 2024) 

  1. All products under Standard 16-05-02 are applicable 
  2. Semiconductor laser eye treatment machine 
  3. Excimer laser corneal refractive therapy machine 
  4. Q switch Nd-doped yttrium aluminum garnet laser eye treatment machine 

Intraocular Lens (April 1st, 2023) 

  1. All products  

Obstetrics and Gynecology Measurement and Monitoring Equipment (May 1st, 2023) 

  1. Ultrasound Doppler fetal monitoring equipment 
  2. Ultrasound Doppler fetal heart rate equipment 

Obstetrics and Gynecology Diagnostic Instruments (May 1st, 2023) 

  1. Gynecological ultrasound diagnostic equipment 

Updated Electrical Safety Standards for Medical Devices 

The NMPA also updated an electromedical safety standard (BG 9706.1-2020) which will come into full effect by May 1st, 2023. An article on the topic can be found here.

Due to the fact it can take up to 12 months to create qualified test certificates, manufacturers with electromedical devices that have not been tested to the new Standard should begin the process right away in order to ensure uninterrupted market access in China.  

The steps to ensure the new electromedical safety standards are:  

STEP 1: Update the product technical requirements from GB 9706.1-2007 to GB 9706.1-2020. 

STEP 2: Import and test the device in China according to the new standard GB 9706.1-2020.  Testing fees are usually approximately US$10,000. 

STEP 3: The China Agent of the IMDRC must submit a registration information change application to NMPA including the qualified test reports. NMPA application processing fees are US$6,400 for risk Class II medical devices and US$7,700 for risk Class III medical devices. 

Note: Products not tested to the new standards will not be renewed by the NMPA until valid test reports have been submitted. Several manufacturers have already reported market interruption issues due to non-compliance with the new requirements. 

Come Grow With Us 

Whatever the situation, Asia Actual has regulatory experts throughout Asia ready to help your device expeditiously achieve market access and begin, or continue, growing your sales in the region.    

Asia Actual is a regulatory consulting company specializing in helping manufacturers grow their sales through independent license holding, direct fulfillment, and a variety of sales channel support services. 

 

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