Regulations on business operations of medical devices have been further tightened as of 1 May 2022, as authorities work on updating existing guidelines.
To improve existing industry guidelines, the State Administration for Market Regulation released the latest version of the Measures on Supervision and Administration of Business Operations of Medical Devices (“the Measures”), which took effect on 1 May 2022.
The Measures enforce stricter regulatory requirements and strengthen the supervision, inspection and management of medical device production and operation throughout all business activities. A medical device registration and record-filing system optimizes administrative procedures for quality and traceability management.
Below are some of the highlights:
Formalities for Record-Filing
Renewal of Class III Medical Devices Trading License
Article 16 states that the applicant shall file a renewal application 90 to 30 working days prior to the license’s expiration date. Failure to apply before the pre-specified time shall result in an unaccepted application.
The original permit issuing authority shall conduct on-site verification if necessary and decide on the approval status before the original license expires, as per Article 13 of the Measures.
An extension shall be granted if the prescribed conditions are met, and the identification number of the renewed license shall remain unchanged. Rectification within a specified period shall be required for applications that fail to meet the prescribed conditions; cases that fail to meet the specified requirements after rectification shall not be renewed, and the reason(s) shall be issued in writing. Approval is deemed to be granted if a decision is not made within the time limit.
If the approval date of the renewed license is within the validity period of the original permit, the new starting date shall be the day after the initial license expires; if the date of approval is not within the original license’s validity period, the new starting date shall be the date of approval.
Applying for Class II Medical Devices Trading License
Article 23 states that any business operators that wish to apply for a Class III Medical Devices Trading License and register for Class II medical devices at the same time – or entities that have secured a Class III Medical Devices Trading License and wish to register for Class II medical devices – may be exempt from submitting relevant documents.
Article 25 states that exemption from registration is permitted for Class II medical devices whose product safety and effectiveness are not affected by the distribution process. The specific product directory shall be formulated, modified and published by the National Medical Products Administration (“NMPA”).
Requirements for Quality Management
Article 30 states that medical device operating enterprises shall enact a tracing system to ensure product traceability. A unique identification system shall be implemented as guided by the relevant regulations previously issued by the NMPA, National Health Commission and National Healthcare Security Administration (“NHSA”).
Purchase Verification Records System
Article 32 states that medical device operating enterprises shall establish a purchase verification records system: the qualifications of the supplier, medical device registration certificate and other information on file shall be verified when purchasing medical devices. The records shall be true, accurate, complete and traceable. Such records include:
- Name, model, specification and quantity of the medical device
- Identification number of the registration certificate or of the medical device
- Name, production license number or identification number of the medical device registrant, filer and manufacturer
- Production batch number or serial number, validity period or expiry date, purchase date, etc. of the medical device
- Name, address and contact details of the supplier
The records shall be kept for two years after the medical device expires; if there is no validity period, it shall not be less than five years. Purchase verification records of implantable medical devices shall be kept permanently.
Article 42 states that if the medical device operating enterprise discovers that the device it is selling does not meet the mandatory standards or technical requirements, or that the device has other defects, it shall cease operations immediately, notify the device registrant, filer and other relevant parties and authorities, and file for business cessation. If the device registrant or filer decides that the device needs to be recalled, it shall be done so immediately.
Supervision and Inspection Measures
Article 46 states that the drug regulatory authorities of provinces, autonomous regions and municipalities directly under the Central Government shall supervise and inspect the management of medical device operation in their respective administrative areas. The district-divided authorities at city or county levels shall supervise and inspect medical device business activities in their respective administrative regions.
Targeted Supervision and Inspection
Article 52 states that the relevant drug regulatory authority shall conduct targeted supervision and inspection under the following circumstances:
- Serious problems are discovered in the previous year’s inspection
- The enterprise has been subject to administrative penalties for violating relevant laws and regulations
- The enterprise has been deemed in need of targeted inspection after a risk assessment
- The enterprise has a bad credit record
- Medical device wholesalers or Class III medical device retailers who are newly established or have undergone major business changes
- Those that provide specialized storage and transportation services for other medical device registrants, filers, manufacturers and operating enterprises of medical devices
- Other circumstances that require targeted supervision and inspection
In conclusion, medical device operating enterprises should acquaint themselves with the revised guidelines and act accordingly by making the necessary business and administrative adjustments in advance to ensure full compliance.