The purpose of Post-Marketing Control is to ensure that medical devices distributed to consumers are wholesome and have quality that complies with the medical device standards. As a result, this measure deals primarily with the activities of enforcement. Inspection of all medical device factories and premises throughout the country is conducted regularly, together with the sampling of products for analysis and assaying to ensure compliance with legal requirements. Market surveillance is performed in an all-year-round manner, including the investigation of product labeling and the collection of marketed product samples at the inspecting place. All claims imprinted on the labels of medical device products must have the support evidence kept in a ready-to-be-delivered manner when inquired by the medical device control officer.
In case of violation, actions like seizure, recall, and prosecution will be executed. In general, there are two types of inspections:
Regular Inspection. This is a planned inspection to ensure that the FDA annual plan on medical devices has been implemented successfully.
- Plant Set-up Inspection. This is a comprehensive check of newly established firms or the modified ones for compliance with laws or regulations, prior to issuing a license.
- Routine Inspection. This is a periodic inspection particularly at the premises that have received licenses.
- Follow-up Inspection. This is to confirm that the certain correction of the license holders or firms after the former inspection has indicated.
- Ports of Entry Inspection. This is done by medical device inspectors at the checkpoint to ensure the safety of medical devices entering into the country in compliance with the relevant regulations.
Suspected or Petitioned Inspection. This is a particular type of inspection with the specific aim to investigate or gather necessary evidence for taking legal action. It includes an inspection to find out the cause of the complaint or rejected medical devices from the importing country, so as to solve the problems of manufacturers and medical device exports.
Plant inspections and import inspections are performed periodically as planned. The inspection is undertaken in conjunction with the collection of product samples. It is usually carried out in response to the complaints or reports of adverse reactions or as part of the surveillance. The collected product samples are sent to the Department of Medical Sciences, Ministry of Public Health, for testing for fraudulent characteristics or harmful effects to human health. Any products found to be harmful to human health will be recalled or confiscated under the jurisdiction of the Medical Device Control Division and will eventually be destroyed in order to ensure that such products will not be re-marketed. Consequently, the responsible persons will be charged with placing the hazardous medical device products on the market.
One of the objectives of all manufacturers in engaging in medical device business is to deliver the standard-quality and safe-for-use products to customers. This objective is in line with that of the Medical Device Control Division, i.e. to ensure that the medical device products placed on the market are safe for use. Yet, the manufacturers’ practices play a major role in manufacturing such products. Without appropriate guidelines for manufacturing practices, the manufacturers will hardly be able to develop their manufacturing practices.
Hence, the objective of this activity is firstly to provide basic steps for medical device manufacturers to correctly practice and further improve the rapidly-developing medical device manufacturing industry within the country. The coverage of this guidelines ranges from the building or facilities where productions are to take place, to the equipment or instruments, personnel, raw materials, and all the processes relating to the production of medical devices.
The production of good-quality medical devices requires close supervision, thorough monitoring and inspection in every step of the manufacturing processes. As such, the manufacturing practices of medical device manufacturers will be annually assessed alongside with product sampling and testing.
The good manufacturing practices (GMP) guidelines for medical devices are now in the preparation process and expected to be published and distributed in the near future. The implementation will then follow. Certificates of Good Manufacturing Practices will be awarded to the manufacturers with the qualified outcome of assessment and have passed the product testing.
Requests for advertisement approval of must be submitted with the following :
(1) an instrument, product, or article intended for use in medical practice, nursing, midwifery practice, general medical or veterinary practice, in pursuance of the governing laws, or
(2) an instrument, product, or article intended for use to affect the health structure or any physiological function of humans or animals, will be regarded as medical devices, according to the Medical Device Act.
Advertisements in all media will be investigated as part of post-marketing surveillance. All information on the products with special claims must be kept by the manufacturers or importers in a ready-to-be-delivered manner when inquired by the medical device control officer. Advertisement investigation is also performed in an all-year-round manner.
Any medical devices with an overclaim in the label or advertisement will be recalled and followed by plant or import inspections.
At the provincial level, Provincial Public Health Offices in 75 provinces throughout the country have been delegated the authority by the FDA to take responsibility, to a certain extent, according to the Medical Device Act. Each Provincial Public Health Office is in charge of medical device control in its province, in cooperation with the FDA at the central level regarding policies; and its duties and responsibilities are similar to those of the FDA.