Striving to meet good manufacturing practices (GMP) for medical devices in China can be challenging. The following article will provide answers to the most common questions about GMP for medical devices in China.
While it is true that good manufacturing practices (GMP) for medical devices in China can be challenging to achieve, they are necessary to ensure that your product is safe and effective for use. Having good manufacturing practices (GMP) in place will provide peace of mind to you as a manufacturer, knowing that you are producing consistent, quality products and therefore are reducing risk to your company and the user while simultaneously protecting the company reputation.
In order to expand its medical device market, China is driving GMP standards to be more closely aligned to International Organization for Standardization (ISO) standards. Guidelines are applicable to onsite inspections for sterile, implantable and IVD devices.
GMP Areas of Focus
Good manufacturing practices (GMP) for medical devices tend to be centered around the following areas;
Key Components of GMP for Medical Devices
Ensuring that a manufacturer pays special attention to the following will result in acceptable, GMP standards;
- Acceptable facilities
- All clinical trials must take place at an NMPA accredited institution
- Properly trained personnel
- Safe materials must be used for manufacturing
- A thoroughly documented clinical trial
- Documentation and reporting of adverse events
- Upkeep of quality control even after GMP inspection or audit
Enforcement of GMP for Medical Devices
Upon registration, a manufacturer must apply for their license in which case, a GMP audit will be performed.
Thereafter, in an attempt to enforce GMP, surprise inspections will be implemented. A manufacturer may be fined for being out of compliance with good manufacturing practices. You may consider hiring an experienced Chinese Quality Assurance Inspector to ensure that your process meets GMP standards.
Overseas Manufacturing Inspection
On December 28th, 2018, National Medical Products Administration (NMPA) issued ‘Administrative Regulations of Drug and Medical Device Overseas Inspection’ (NMPA order No. 101 2018) implemented from the date of publication. Overseas inspection is the global common way for medical device inspection and one of the important steps for Chinese medical device inspection to be internationalized. The Regulations have essential effects for supervising overseas enterprises to comply with Chinese regulations.
NMPA is responsible for medical device overseas inspection. NMPA makes inspection tasks through risk evaluation and random selection in accordance with the suggestions of draft inspecting medical devices, R&D site and manufacturing site from relevant departments. Center for Food and Drug Inspection of NMPA (CFDI) is responsible for specific organization and implementation of medical device overseas inspection. Relevant departments will assist with the overseas inspection.
Overseas MAH shall submit CFDI ‘Letter of Authorization’ and ‘Basic Information Table of Overseas Inspecting Products’ in 20 workdays and submit main documents of inspecting site and other necessary materials in 40 workdays after receiving ‘Announcement of Overseas Inspection’.
There are several new regulations that overseas enterprises need to consider:
- Overseas inspection doesn’t only contain manufacturing site but also includes overseas R&D location.
- Delay, obstruction, restriction, and rejection for the inspection are all determined as ‘Fail’.
- If the enterprise has serious quality risk, NMPA will immediately conduct risk control measures.
- CFDI can acquire and inspect relevant technical files with crypto-security and include them into inspection files.
- The enterprise should keep normal condition and cooperate to inspect relevant equipment and sites. In accordance with inspection schedule, the enterprise shall arrange dynamic manufacturing process of inspected products and provide needed documents, records, e-data in time.
- If necessary, CFDI can sample and seal products with sampling documents. MAH shall ensure the package and transportation condition of the sample cannot affect sample quality.
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 certified NMPA (CFDA) legal agent with offices in Boston and Beijing, we 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.