Here’s the latest regulatory news for January 2020 affecting MedTech pros who offer devices and IVDs in China, provided by China Med Device, LLC. Forward this newsletter to a colleague and opt-in here. For additional tools to secure China success, see our Resources section below.
Policies
Allow Import None-NMPA Approved Medical Devices Amid Coronavirus Outbreak
To help contain the novel Coronavirus (“2019-nCoV”), NMPA issued the Notice of Importing None-NMPA Approved Medical Devices on Jan 27, informing provincial counterparts to allow import none-NMPA approved devices but have FDA approval, CE mark, or Japan approval.
It further specifies that “the provincial NMPA shall cooperate with local departments of Industry and Information Technology, Health and Customs to ensure smooth importation and customs clearance. Provincial NMPA shall issue the Certificate of Import License if needed.”
As of February 5, provincial NMPA offices granted Emergency Approvals to 72 medical devices, with focus on protective supplies, sterilization and ventilation devices.
For the three prerequisites for Emergency Approval, and the category of urgently needed medical supplies, please read full article
Clinical Trials to be More Harmonized with International Standards
NMPA published the Technical Guidelines on Medical Device Clinical Evaluation (draft) on January 2, 2020 for feedback.
In the Clinical Evaluation section, NMPA recognizes that a wide range of Real-World Data (RWD) can be used for clinical experience; In the Clinical Evaluation section, NMPA explains that, although clinical trials are usually needed for high risk and novel medical devices, it may not be necessary for established technology.
NMPA will pay more attention on full life cycle clinical evaluation. Read full article
How to Address Submission Deficiency in China?
NMPA published the Medical Device Submission Document Administrative Measures during the Supplement Phase (final) on January 16, 2020.
Commonly known as “Submission Deficiency” by U.S FDA, the Supplement Phase is needed if the registration documents submitted by the applicant cannot meet the relevant regulations or technical standards.
The Administrative Measures list five scenarios when Supplement Phase is initiated. It also provides suggested content and format for notification letters for NMPA reviewers, and suggested format for response letters and submission materials for manufacturers. Read full article
Guidelines
NMPA Finalizes Tumor Mutation Reagents Guideline for CDx
NMPA published the Registration Technical Review General Guideline for Performance Evaluation of the Reagents Used for Tumor Related Genetic Mutation Test (high-throughput sequencing).
While NGS is widely recognized for having advantages on both sequencing scale and detection of unknown genetic mutations, some aspects are still challenging. This important document not only guides the manufacturers with products registration, but also helps with R&D process. Read full article
Two draft guidelines were issued in January 2020:
- Technical Guideline on Virus Inactivation Process Verification for Allogeneic Implanted Medical Device (draft)
- Clinical Evaluation Guideline on Comparison of X-ray Computed Tomography Equipment (draft)
Recalls
NMPA Announces Recall Notices for Seven Imported Medical Devices
Products from Johnson & Johnson, Medtronic, GE and Philips were issued recalls along with 3 other imported medical devices. See the full list of companies and recalled devices
Approvals
Emergency Approvals Surged under Coronavirus Outbreak
China has accelerated the Emergency Approvals amid the threat of Novel Coronavirus (“2019-nCoV”). National NMPA granted seven Emergency Approvals to Coronavirus Nucleic Acid Detection Reagent manufacturers in January, while provincial NMPA offices paid all-out efforts to help contain the virus. Read full article
Innovative Device Overview in 2019: Only 20% Claimed by U.S./ European Manufacturers
Of the 39 medical devices granted Innovative Device Status in 2019, only eight (just 20%) were imported devices. Since domestic and overseas manufacturers have equal opportunity for this program, U.S. and European companies may not be taking full advantage.
Read the article for the full list of imported Innovative Devices in 2019, the three fast-track channels and takeaways for overseas manufacturers.
About China Med Device, LLC
China Med 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.