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Polycarbonate (PC), as a biodegradable polymer material, has various application scenarios in the medical field. These include disposable ophthalmic surgical knives, ophthalmic trocars/cannulas, polymer materials and products for dentures, orthopedic core drill, auxiliary instruments for vertebroplasty, and ring-handle syringes. As a raw material for medical device products, PC can undergo Master File registration. This authorizes medical device registration applicants to reference it as part of their regulatory submission when applying for medical device registration.
Technical documentation for medical device raw materials (excluding in vitro diagnostic reagents) generally includes descriptions of the raw material composition, physicochemical property studies, biological evaluation data, toxicological risk analysis, and process studies. The performance indicators of PC are as follows (for reference only):
1) Appearance
2) Physical Properties
Melt volume-flow rate (MVR), Density, Izod notched impact strength
3) Chemical Properties
Reducing substances, Acidity/alkalinity, Residue on evaporation, Total metal ion content, Metal ions (barium, chromium, copper, lead, tin), Metal ions (cadmium), UV absorbance
4) Biocompatibility
When the raw material is used for producing medical devices, the final product shall undergo biological evaluation in accordance with the requirements of GB/T 16886.1.
For example, when PC is used in ophthalmic trocars/cannulas which have a short-term contact with human tissue, the following three tests should be considered: cytotoxicity, irritation or intracutaneous reactivity, and sensitization.
5) Shelf Life and Packaging/Transportation
Shelf life and packaging/transport validation may be performed per requirements for medical device raw materials. Relevant testing can be conducted with reference to: Guidance on Registration Documentation for Shelf Life of Passive Implantable Medical Devices, GB/T 19633 series standards, and YY/T 0681 series standards
As of July 31, 2025, the National Medical Products Administration (NMPA) has successfully registered 51 polycarbonate (PC) raw material products. The summary is as follows:
No. | Owner Name | Master File Registration Item | Master File Registration Number | Registration/Update Date |
22 | Covestro (Shanghai) Investment Co., Ltd. | Polycarbonate Resin Raw Material Master File - MAKROLON 2458 550115 | M2021022-001 | 2023/8/14 |
23 | Covestro (Shanghai) Investment Co., Ltd. | Polycarbonate Resin Raw Material Master File - MAKROLON RX2430 451118 | M2021023-001 | 2023/12/8 |
45 | Covestro (Shanghai) Investment Co., Ltd. | Polycarbonate Resin Raw Material Master File - MAKROLON 2458 650346 | M2022013-002 | 2023/9/18 |
46 | Covestro (Shanghai) Investment Co., Ltd. | Polycarbonate Resin Raw Material Master File - MAKROLON 2458 013528 | M2022014-003 | 2024/3/15 |
57 | Covestro (Shanghai) Investment Co., Ltd. | Polycarbonate Resin Raw Material Master File - MAKROLON 2458 550047 | M2022025-001 | 2023/12/8 |
60 | Covestro (Shanghai) Investment Co., Ltd. | Polycarbonate Resin Raw Material Master File - MAKROLON 2458 550100 | M2022028-001 | 2023/12/8 |
61 | Covestro (Shanghai) Investment Co., Ltd. | Polycarbonate Resin Raw Material Master File - MAKROLON 2458 550099 | M2022029-001 | 2023/12/8 |
62 | Covestro (Shanghai) Investment Co., Ltd. | Polycarbonate Resin Raw Material Master File - MAKROLON 2458 659606 | M2022030-001 | 2023/12/8 |
63 | Covestro (Shanghai) Investment Co., Ltd. | Polycarbonate Resin Raw Material Master File - MAKROLON 2458 650019 | M2022031-001 | 2023/12/8 |
64 | Covestro (Shanghai) Investment Co., Ltd. | Polycarbonate Resin Raw Material Master File - MAKROLON 2458 551591 | M2022032-001 | 2023/12/8 |
65 | Covestro (Shanghai) Investment Co., Ltd. | Polycarbonate Resin Raw Material Master File - MAKROLON Rx2430 350079 | M2022033-001 | 2023/12/8 |
66 | Covestro (Shanghai) Investment Co., Ltd. | Polycarbonate Resin Raw Material Master File - MAKROLON 2458 650022 | M2022034-001 | 2023/9/18 |
70 | Covestro (Shanghai) Investment Co., Ltd. | Polycarbonate Resin Raw Material Master File - MAKROLON 2458 550048 | M2022038-001 | 2024/2/6 |
71 | Covestro (Shanghai) Investment Co., Ltd. | Polycarbonate Resin Raw Material Master File - MAKROLON 2458 551608 | M2022039-001 | 2024/2/6 |
74 | Covestro (Shanghai) Investment Co., Ltd. | Polycarbonate Resin Raw Material Master File - MAKROLON Rx2635 450003 | M2022042-001 | 2023/12/8 |
75 | Covestro (Shanghai) Investment Co., Ltd. | Polycarbonate Resin Raw Material Master File - MAKROLON Rx2635 451118 | M2022043-001 | 2023/12/8 |
76 | Covestro (Shanghai) Investment Co., Ltd. | Polycarbonate Resin Raw Material Master File - MAKROLON Rx2430 551608 | M2022044-001 | 2024/2/6 |
81 | Covestro (Shanghai) Investment Co., Ltd. | Polycarbonate Resin Raw Material Master File - MAKROLON 2858 550115 | M2022049-001 | 2023/9/18 |
117 | Covestro (Shanghai) Investment Co., Ltd. | Polycarbonate Resin Raw Material Master File - MAKROLON 2458 20002 | M2022084-002 | 2023/12/8 |
118 | Covestro (Shanghai) Investment Co., Ltd. | Polycarbonate Resin Raw Material Master File - MAKROLON RX3440 451118 | M2022085-001 | 2023/10/19 |
119 | Covestro (Shanghai) Investment Co., Ltd. | Polycarbonate Resin Raw Material Master File - MAKROLON 2458 600031 | M2022086-001 | 2023/12/8 |
123 | Covestro (Shanghai) Investment Co., Ltd. | Polycarbonate Resin Raw Material Master File - MAKROLON 2858 450057 | M2022091-002 | 2023/9/18 |
124 | Covestro (Shanghai) Investment Co., Ltd. | Polycarbonate Resin Raw Material Master File - MAKROLON 2458 500111 | M2022092-002 | 2024/3/15 |
125 | Covestro (Shanghai) Investment Co., Ltd. | Polycarbonate Resin Raw Material Master File - MAKROLON 2858 013282 | M2022093-001 | 2024/2/6 |
126 | Covestro (Shanghai) Investment Co., Ltd. | Polycarbonate Resin Raw Material Master File - MAKROLON 2858 450059 | M2022094-002 | 2023/9/18 |
127 | Covestro (Shanghai) Investment Co., Ltd. | Polycarbonate Resin Raw Material Master File - MAKROLON 2458 013771 | M2022095-002 | 2024/3/15 |
128 | Covestro (Shanghai) Investment Co., Ltd. | Polycarbonate Resin Raw Material Master File - MAKROLON RX1805 558994 | M2022096-001 | 2023/9/18 |
129 | Covestro (Shanghai) Investment Co., Ltd. | Polycarbonate Resin Raw Material Master File - MAKROLON RX1805 451118 | M2022097-001 | 2023/9/18 |
130 | Covestro (Shanghai) Investment Co., Ltd. | Polycarbonate Resin Raw Material Master File - MAKROLON RX2440 450058 | M2022098-001 | 2023/10/19 |
131 | Covestro (Shanghai) Investment Co., Ltd. | Polycarbonate Resin Raw Material Master File - MAKROLON RX2530 558994 | M2022099-001 | 2023/10/19 |
132 | Covestro (Shanghai) Investment Co., Ltd. | Polycarbonate Resin Raw Material Master File - MAKROLON RX2530 451118 | M2022100-001 | 2023/10/19 |
133 | Covestro (Shanghai) Investment Co., Ltd. | Polycarbonate Resin Raw Material Master File - MAKROLON RX2440 451118 | M2022101-001 | 2023/10/19 |
137 | Covestro (Shanghai) Investment Co., Ltd. | Polycarbonate Resin Raw Material Master File - MAKROLON 2458 010110 | M2022105-001 | 2023/8/14 |
160 | Covestro (Shanghai) Investment Co., Ltd. | Polycarbonate Resin Raw Material Master File - MAKROLON 2458 350078 | M2023020-001 | 2023/12/8 |
164 | Covestro (Shanghai) Investment Co., Ltd. | Polycarbonate Resin Raw Material Master File - MAKROLON 2458 850064 | M2023024-002 | 2024/3/15 |
165 | Covestro (Shanghai) Investment Co., Ltd. | Polycarbonate Resin Raw Material Master File - MAKROLON 2858 850371 MAS020 | M2023025-001 | 2023/9/18 |
166 | Covestro (Shanghai) Investment Co., Ltd. | Polycarbonate Resin Raw Material Master File - MAKROLON RX2430 558994 | M2023026-001 | 2023/12/8 |
167 | Covestro (Shanghai) Investment Co., Ltd. | Polycarbonate Resin Raw Material Master File - MAKROLON 2858 551474 | M2023027-002 | 2023/9/18 |
236 | Covestro (Shanghai) Investment Co., Ltd. | Polycarbonate Resin Raw Material Master File - MAKROLON 2858 010110 | M2023096-000 | 2023/8/14 |
297 | Wanhua Chemical Group Co., Ltd. | Polycarbonate Resin Raw Material Master File - CLARNATE MR156 4117 | M2023157-000 | 2023/12/8 |
339 | Wanhua Chemical Group Co., Ltd. | Polycarbonate Resin Raw Material Master File - CLARNATE ME205 9102 | M2024009-000 | 2024/1/15 |
418 | Wanhua Chemical Group Co., Ltd. | Polycarbonate Resin Raw Material Master File - CLARNATE ME155 9102 | M2024088-000 | 2024/3/15 |
421 | Wanhua Chemical Group Co., Ltd. | Polycarbonate Resin Raw Material Master File - CLARNATE MR076 4117 | M2024091-001 | 2024/4/11 |
441 | Wanhua Chemical Group Co., Ltd. | Polycarbonate Resin Raw Material Master File - CLARNATE ME105 9102 | M2024111-000 | 2024/4/11 |
506 | Wanhua Chemical Group Co., Ltd. | Polycarbonate Resin Raw Material Master File - CLARNATE ME075 9102 | M2024176-000 | 2024/6/8 |
512 | Covestro (Shanghai) Investment Co., Ltd. | Polycarbonate Resin Raw Material Master File - MAKROLON 2858 012896 | M2024182-000 | 2024/6/8 |
524 | Covestro (Shanghai) Investment Co., Ltd. | Polycarbonate Resin Raw Material Master File - APEC 1745 551022 | M2024194-000 | 2024/6/8 |
749 | Covestro (Shanghai) Investment Co., Ltd. | Polycarbonate Resin Raw Material Master File - MAKROLON 2258 550115 | M2024419-000 | 2024/12/27 |
764 | Covestro (Shanghai) Investment Co., Ltd. | Polycarbonate and ABS Alloy Raw Material Master File - BAYBLEND M850XF 000000 | M2025007-000 | 2025/1/17 |
774 | Covestro (Shanghai) Investment Co., Ltd. | Polycarbonate and ABS Alloy Raw Material Master File - BAYBLEND M301FR 000000 | M2025017-000 | 2025/1/17 |
792 | Covestro (Shanghai) Investment Co., Ltd. | Polycarbonate and ABS Alloy Raw Material Master File - BAYBLEND M850XF 013771 | M2025035-000 | 2025/2/11 |
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