The Ministry of Health conducts assistance for good submission practice training to help medical device companies to register surgical instruments.
The following are some important points that need to be underlined for medical devices companies who wish to register their surgical instruments.
1. In the LoA, only Brand+Product name need to be mentioned. List of Models doesn’t need to be included in LoA.
2. For List of Raw Material document, composition and percentage of the material must be mentioned.
3. In the manufacturing process there must be In Process Control and mentioned the entire process from raw material to finished product.
4. Minimum 3 representatives of CoA Finished Products can be submitted for bunch of components in the group of devices.
5. For large device, labels should be placed in the product.
During the discussion MoH also mentioned to register SET medical device, i.e. surgical instrument set, each component inside this set must be registered first. Besides, MoH also announce that the days calculation system in the online registration is changed from calendar days to working days.
Analysis and Evaluation of Industry Capability in Fulfilling Class A and B Good Submission Practice