The implementation of medical device MAH in China is aiming at promoting the reform of medical device review and approval mechanism and enhancing the management of medical device whole life cycle.
On April 2, 2022, NMPA issued a notice to provide recommendations on how to execute cross-regional MAH surveillance. These requirements are covered the current Measures for the Supervision and Administration of Medical Device Production in China are Bureau Order No. 53 issued in 2022.
More and more overseas manufacturers pay attentions on MAH, since they are aware of localization urgency.
Affected by factors such as supply chain, the cost of imported medical devices is higher than that of domestic medical devices. In the past, many foreign manufacturers do not have the urgency of localization. However, since the implementation of the volume-based centralized procurement, product prices plummeted, and the market competition has become more intense. Foreign manufacturers have started to consider how to reduce costs.
Regulatory Restrictions on the contract manufacturing in China
The current Measures for the Supervision and Administration of Medical Device Production in China are Bureau Order No. 53 issued in 2022.
For regulatory jurisdiction is described as
Those engaged in the production of medical devices or the supervision and administration of medical devices within the territory of the People’s Republic of China shall abide by the Measures. The most significant difference between this provision and the 2014 version is that the requirement for the filing of OEM entity only for export has been removed.
The medical products administrations of provinces, autonomous regions and municipalities is responsible for the supervision and administration of the production of medical devices within the administrative area of the province, autonomous regions and municipalities.
The National Medical Products Administration (NMPA) is responsible for the supervision, inspection, and management of overseas medical device registrants.
For contract production management is described as
Article 32: If the medical device registrant or filing entity entrusts any other party for production, the quality assurance ability and risk management ability of the entrusted party shall be assessed, a quality agreement for entrusted production shall be signed in accordance with the guidelines for entrusted production quality agreement formulated by NMPA, and the fulfillment of relevant agreed obligations by the entrusted party shall be monitored.
Although the scope of medical device registrants and filing entities is not limited here, when combined with the following terms:
Article 61: If the imported medical device registrant and filing entity appoints a domestic business entity as the agent, the agent shall assist the registrant and filing entity in fulfilling the responsibilities and obligations as prescribed in the Regulations on the Supervision and Administration of Medical Devices and under the Measures.
Article 62: The production of the imported medical devices shall meet the relevant requirements for producing medical devices in China and accept the overseas inspections organized by the NMPA. The agent shall be responsible for coordinating and cooperating with the related work of the overseas inspection.
Imported medical device registrants, filing entities, and agents refuse, obstruct, delay, or evade the overseas inspection organized by NMPA, resulting in the inability to carry out the inspection work and the inability to confirm the effective operation of the quality management system. NMPA may handle the situation by the provisions of Article 72, paragraph 2, of the Regulations on the Supervision and Administration of Medical Devices.
To sum up, NMPA has not yet given regulatory consent to foreign companies entrusting Chinese companies to manufacture and enter the Chinese market as imported products.
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