Monthly CFDA News Roundup (July)

Monthly CFDA News Roundup covers government reports, policies, standards, guidelines, QA/recall/AE, and new approvals in medical device and IVD in China. It is edited by China Med Device, LLC (www.ChinaMedDevice.com), a consulting firm specializing in China CFDA regulatory, CRO and market access services.

Highlights:

1. New Medical Device Classification Catalog, with 1,157 added subcategories and 40 reclassifications, became effective on August 1^st, 2018
2. Shanghai Half Year Recall Report shows imported devices accounts for 93% of the total recalls.
3. 3 ophthalmic devices from Johnson & Johnson were recalled in one week.
4. CFDA issued an innovation approval to quantitative pulmonary blood flow measuring system, by Pulse Imaging, a company based in Shanghai.

Government Report

Shanghai CFDA office released Medical Device Half Year Recall Report on July 20. Total 165 medical devices have been voluntarily recalled in Shanghai for the first half of 2018, including 154 imported devices (93%) and 11 domestic devices (7%). Foreign manufacturers include Roche, Siemens, GE, Philips, Abbott, Becton Dickinson, Boston Scientific, Smith &Nephew, etc.

The number of voluntary recalls in the first half of 2018 was increased by 66.7% year-on-year.

For reasons of the recalls and suggestions given by Shanghai CFDA office, click HERE.

Policy

1. Medical Device Classification Catalog, replacing the initial one published in 2002, became effective on August 1, 2018. Compared with the previous catalog, key changes are:

• The number of device categories decreased from 43 to 22;
• 1,157 subcategories are added;
• Product description and intended are added to determine the classification;
• More examples of device names are provided;
• 40 reclassifications.

For more information about the Classification Catalog, please click HERE.

2. CFDA published an article on biodegradable materials and called for research and development of those materials. CFDA approved biodegradables include hernia mesh, dura mater, nerve repair material, anal fistula, absorbable fixation nail, tissue clip, facial injection filling material, degradable sinus stent, sodium hyaluronate ophthalmic viscoelastic, artificial cornea Matrix, dermal matrix, etc.

For the 28 standards and guidelines CFDA specifies in the article, please email info@ChinaMedDevice.com.

Guideline

CFDA issued three dental device guidelines for feedback. Feedbacks need to be summited by August 28.

• Technical Review Guideline on Synthetic Resin Teeth
• Technical Review Guideline on Digital Imprinter
• Clinical Evaluation Guideline on Maxillofacial Cone Beam Computed Tomography

QA/Recall/AE

1. CFDA announced recall notices from 17 foreign manufacturers for 20 medical devices and IVDs. Johnson & Johnson, Abbott, Philips, Stryker, Biomet and Depuy are on the list. Among them, 3 ophthalmic devices from Johnson & Johnson were called in one week:

• Contact lens
• Toric single-piece intraocular lens
• Aspheric single-piece intraocular lens

For the reasons of recall and the model numbers, please email info@ChinaMedDevice.com.

For the Clinical Guideline on Rigid Gas Permeable (RGP) Contact Lens and Soft Contact Lens, please click HERE.

2. CFDA issued National Inspection Notice #65 and identified 7 devices: intraocular lens, slit-lamp microscope, carbon dioxide (CO₂) laser, light therapy machine, suction tube, electronic thermometer, nerve and muscle stimulator.

Devices from 5 foreign manufacturers, out of 40 in total, have been found defects:

• HexaVision SARL: intraocular lens
• Rayner Intraocular Lenses: intraocular lens
• Lenstec: intraocular lens
• Bausch & Lomb: intraocular lens
• Natus Medical: light therapy machine

New Approval

1. CFDA published Directory of Registered Medical Devices for June 2018. 53 domestic class III, 22 imported class III and 21 imported class II medical devices have been approved. Siemens, Philips, Roche, Medtronic, Edwards Lifesciences, Alcon and Stryker are on the list.

2. CFDA granted innovation approval status to 1 foreign manufacturer and 2 domestic ones.

• 富士レビオは(Fushi Ruibiou): Hepatitis B surface antigen (HBsAg) detection kit
• MicroPort: intraoperative stent
• Zhuoruan Medtech Xiansida Hangtian Taixin: biodegradable hernia mesh

3. CFDA issued an innovation approval to quantitative pulmonary blood flow measuring system, by Pulse Imaging, a company based in Shanghai. It obtains Quantitative Flow Ratio (QFR) based on quantitation with coronary angiography.

For summary of innovation approval guideline, click HERE. For complete English version of the guideline, please email info@ChinaMedDevice.com.

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About China Med Device, LLC

China Med Device, LLC provides turn-key solutions for western medical device/IVD companies to enter China with regulation and commercialization services. Our CFDA regulatory services cover strategy, premarket submission, clinical evaluation, CRO, QA and post market compliance. We are experienced in handling innovation approvals and priority reviews. Our commercial services cover market assessment research, reimbursement, partnership, distribution qualification and management. We have offices in Beijing, Suzhou and Boston. Our management team has 100+ years of combined experience in medical device and IVD and has been involved with 1,000+ CFDA certificates and 200+ companies’ success.