CFDA issued 27 device guidelines on Oct.8th, 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.
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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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.