Blockbuster! Official release: 301 medical devices have been removed from the list

Recently, the Medical Device Standards Management Center of the NMPA released the Summary of the Third Classification and Definition Results of Medical Device Products in 2022, and 75 medical devices were directly excluded.

There are 388 classification and definition results of medical devices from July to September 2022 in this summary, including 45 products recommended to be managed according to Class III medical devices, 149 products recommended to be managed according to Class II medical devices, 98 products recommended to be managed according to Class I medical devices, 75 products recommended not to be managed as medical devices, and 4 products recommended to be managed according to the determination procedure of pharmaceutical and mechanical combination products。 It is suggested that 2 products should be determined according to the specific situation, and 15 products should not be separately managed as medical devices.

It is worth noting that since the beginning of the year, the Medical Device Standard Management Center of the NMPA has issued a summary of the results of the classification and definition of medical device products for three times.

In the first batch of classification results released in May this year, 197 medical devices were removed.

In the second batch of classification results released in July, 29 medical devices were also removed.

That is to say, 301 products have been removed from the list since this year and are not managed as medical devices!

As we all know, medical devices should be managed in strict accordance with the standards of the Regulations on the Supervision and Administration of Medical Devices and the Measures for the Supervision and Administration of Medical Device Business Enterprises. In addition, whether the product belongs to medical devices is also an important reference for public medical service institutions such as hospitals when purchasing.

The specific products that have been removed are summarized as follows:

75 products recommended not to be managed as medical devices

（The third batch）

1. Non-medical wrist photoelectric volume pulse wave blood pressure measurement watch

2. Massage instrument for healthy people

3. Laboratory quality control and workflow management software

4. Anti-bedsore mattress

5. Disinfection wipes

6. Nursing machine

7. Ultrasonic probe stabilizer

8. Ear protection spray

9. Auxiliary software for editing radiographic reports for hospital management

10. Antibacterial materials:

11. Apply a hot eye mask on a daily basis

12. Mirror holding arm

13. Extracorporeal endoscope clamping fixer

14. Fixer

15. Surgical guide plate processing materials

16. Nucleic acid sampling workstation

17. Sports mouth protector

18. Sitting moxibustion therapeutic instrument pad sheet

19. Catheter squeezing forceps for blood preparation

20. Anticarious toothpaste

21. Body surface conduit fixing device

22. Urinary sleeve

23. In vitro urinalysis device

24. Humidifying mask:

25. Gynecological lactic acid balancing gel

26. Lactic acid vaginal gel:

27. Intravenous dispensing machine:

28. Lip moistening device:

29. Insulin thermostat

30. Cleaning liquid for eyelid margin:

31. Eye flushing Solution:

32. Viscose stripping agent:

33. Biochemical compound non-fixed value quality control products:

34. Sealing film magnetic bead reaction cup:

35. Laboratory pure water machine:

36. Non constant value composite quality control sample of anti- phospholipid antibody

37. Non constant value quality control sample of anti- SSB antibody

38. Non constant value quality control sample of anti- C1q antibody

39. Non constant value quality control sample of anti-mitochondrial M2 antibody

40. Non constant quality control sample for novel coronavirus (SARS-COV-2) nucleic acid detection

41. Magnetic bead suspender

42. Anti-proliferating cell nuclear antigen antibody non-deterministic quality control

43. Surface culture medium

44. Resistance β 2 Non constant quality control sample of total antibody to glycoprotein I

45. Non constant quality control sample of anti- glutamic acid decarboxylase antibody

46. Anti β 2 Non constant value quality control sample of glycoprotein I antibody immunoglobulin A

47. Non constant quality control sample of anti Jo-1 antibody

48. Pouring agar medium

49. Non constant quality control sample of anti- tyrosine phosphatase antibody

50. Non constant quality control sample of anti-protease 3 antibody

51. Non constant quality control sample of anti- centromeric antibody

52. Microfluidic chip

53. Non constant quality control sample of anticardiolipin antibody immunoglobulin A

54. Non constant value quality control sample of anti- double stranded DNA antibody

55. Non constant quality control sample of anti-histone antibody

56. Non constant quality control sample of anti PM Scl antibody

57. Non constant quality control sample of anti- Ro-52 antibody

58. Non constant quality control sample of anticardiolipin antibody immunoglobulin G

59. Non constant quality control sample of anti- islet cell antibody

60. Cell serum free medium

61. Anti-cardiolipin total antibody is not fixed value quality control product

62. Non constant quality control sample of anti- insulin autoantibody

63. Non constant quality control sample of anti- myeloperoxidase antibody

64. Non constant quality control sample of anti- ribosomal P0 protein antibody

65. Tissue labeling kit

66. Non constant value quality control sample of anti Scl-70 antibody

67. Non constant value quality control sample of anti- Sm antibody

68. Optical reaction cup

69. Anti β 2 Non constant value quality control sample of glycoprotein I antibody immunoglobulin M

70. Resist β 2 Non constant quality control sample of glycoprotein I antibody immunoglobulin G:

71. Non constant quality control sample of anti U1 ribonucleoprotein antibody

72. Non constant quality control sample of anti SSA antibody

73. Non constant quality control sample of anti- glomerular basement membrane antibody

74. Non constant quality control sample of anti- nucleosome antibody

Products not managed as medical devices

(The second batch)

1. Mobile plasma air disinfection machine and protective cover

2. Massage instrument for healthy people

3. Digital pathological image management software for scientific research

4. Mattress

5. Position comfort cushion

6. Sterilization non-woven fabric

7. Medical sodium hyaluronate care gel

8. Medical sodium hyaluronate nursing application

9. Ampoule bottle intelligent opener

10. Eye irrigator

11. Skin allergy screening tape

12. Dental blue ray 3D scanner

13. Oral ulcer wound care cream

14. Screws for stomatology technician room

15. Surface culture medium

16. Tablet sealing agent

17. Waste card collection box

18. Micro-fluidic chip

19. Intelligent cold chain monitoring system

20. Vortex mixer

21. Cold filter plant peptone broth medium

22. Plant peptone broth medium

23. 1 plant peptone

24. Bacteriological AGAR (AGAR # 1)

25. Biological color labeling agent

26. Sweat stain

27. Class Ⅲ biosafety cabinet

28. Intelligent nucleic acid sampling kiosk

29. Nucleic acid sampling kiosk

197 products not managed as medical devices

(The first batch)

1. 3D printing resin tray material

2. taurolidine sealing solution

3. Medical non-woven packaging materials

4. Medical pillowcase

5. Medical quilt cover

6. sterilization with non-woven fabric

7. Absorbent paper for sterilization

8. Sterilization box

9. Disposable eye sterile irrigator

10. Eye moisturizer

11. Eye wash solution

12. Brine cleaning solution

13. Rare earth skin spray

14. Customized sports protector

15. 3D printing and planting of surgical guide plate materials

16. Lifting pressure device for washing liquid bag

17. Washing liquid bag suspension rack

18. PH regulating vaginal tablet

19. Guide ring reamer in oral science and technology room

20. Calcium channel activator for scientific research

21. Sperm agonist for scientific research

22. Dental implant surgical goggles

23. Infusion needle fixation device

24. Corns softening ointment

25. Corns softening liquid

26. Benzene sulfonic acid wound care solution

27. Serum free stem cell culture medium for scientific research

28. Eye cleaning tablet

29. Skin cleansing wipes

30. Neck ostomy adhesive removal wipe

31. Clean wipes

32. Denture

33. Fuel glue

34. Denture forming liquid for stomatology department

35. Teeth Whitening Essence

36. Teeth Whitening Essence

37. Infusion support

38. Bottles and pacifiers for premature babies

39. Skin moisturizer

40. Waterproof glue

41. Position locator for stomatology technician room

42. Reamer for stomatology technician room

43. Atopic dermatitis care ointment

44. Skin stripping solution and neutralizing solution

45. Children’s masks

46. Blood bag tube clipper

47. Cleaning and oiling machine for dental handpieces

48. Oral and nasal spray

49. Needle processor

50. Central venous access device sealing fluid

51. Vaginal lubrication capsules and boosters

52. Waterproof adhesive ring for neck ostomy chassis during bath

53. Neck ostomy bath accessories

54. Nose-beautifying body.

55. Dental handpiece cleaning lubricant

56. Identification light for infusion pipeline

57. Single-use medical mask inner cushion holder

58. Daily vaginal scrubber

59. Denture or braces cleaning gel for extra-oral use

60. Denture cleaning tablets for extra-oral use

61. Negative pressure drainage catheterization kit

62. Extracorporeal male catheterization device

63. Occlusal brackets for the dental technician’s office

64. Birth canal lubrication gel

65. Kapom Obstetric gel

66. Mouth with gargle powder

67. Safety goggles

68. Infant mouth and nose aspirator

69. Probiotic metabolites root canal flushing solution

70. Maintenance agent for surgical instruments

71. Mobile bedside bath machine

72. Loading and unloading multi-purpose outpatient compartment

73. Nucleic acid sampling workstation

74. Collagen material containing autologous chondrocytes

75. Negative pressure drainage device storage device

76. Portable neural regulation in vitro charger auxiliary fixation belt

77. Anti-syringe acupuncture auxiliary device

78. Stainless steel needle for manufacturing medical devices

79. Orthotic decorative stickers

80. Hot compress eye mask

81. Gray nail repair pen

82. Antibacterial gel for birth canal

83. Corneal cross-linking riboflavin solution

84. HPMC nasal spray device

85. Lubricating oil for energy tool head

86. Cavity mirror exhaust pipe

87. Noise reduction ear protection

88. Cleaning brush

89. Skin care product absorption promotion equipment

90. Beauty instrument

91. Sterile protective cover

92. Mattress

93. Seat

94. Ultrasonic probe bracket

95. Specimen bracket

96. Remote video conferencing screen sharing software

97. Dose verification system for quality control

98. TCM knowledge base matching software

99. Clinical guidelines display software

100. Information management platform of chest pain center for scientific research

101. Bone marrow image text report editing software for teaching

102. Radiation therapy planning software for research

103. Children’s Chinese language development dosage chart software

104. Medical waste liquid purification and discharge treatment device

105. Indoor environment disinfection robot

106. Platelet cryoprotectant

107. Shift car for living

108. Nutrition scale matching software

109. Ultrasonic examination times query software

110. Vte prevention and treatment data query software

111. Medical record creation software

112. Chinese medicine knowledge query and matching software

113. Electronic medical record making software for cancer patients

114. Medical record making software for laser therapy

115. Daily use of massage instrument

116. Daily use of warm massage instrument

117. Comprehensive massage instrument

118. Daily pressure protection pad

119. Health care massage apparatus

120. Fitness equipment

121. Joint exercisers for body building

122. Body building puller

123. Air disinfection equipment

124. Electroencephalograph for scientific research

125. Comparison software with built-in diagnostic gold standard

126. Skin care (cosmetic) gel

127. Drug gel

128. Daily use of hot paste

129. Massage instrument for daily use

130. Shock absorbing insole

131. Skin dry oil status analyzer

132. Soft endoscope bedside pre-cleaner

133. Mobile trolley for ultrasonic equipmen

134. X-ray machine quality control equipment

135. Microscopic image Information system for hospital management

136. Daylight illumination simulation lamp

137. Video playback system

138. sponge mattress

139. Active sports video push system

140. Tumor information Collaborative management system software

141. Medication data recording and statistical software

142. Visual probe protection bag

143. Skin anti-injury paste

144. Daily water bath machine

145. Bed for bedridden personnel

146. Boarding chair

147. Bath chair

148. Teaching video management system

149. Electronic scale software for neurological rehabilitation function assessment

150. 3D-printed nylon material

151. Software of pathology quality control and data management system

152. Daily massage instrument

153. Endoscope tip protection hose

154. Mobile electronic endoscope cart

155. Adjustable varicose vein stocking wearing aid

156. Blanket CPR instruction manual

157. Daily use of air cooler

158. Big data AI research platform

159. Intelligent device running state management software

160. Electronic medical record software

161. Electronic psychological scale system bedside frame

162. Carrying belt

163. Toilet chair

164. Electric toilet cleaning bed

165. Endoscope drying storage system

166. Equipment management label

167. Fall detector

168. Data connection hubs for scientific research

169. Daily health massage instrument

170. Daily beauty massage instrument

171. Medicinal plaster

172. Drug Patch

173. Wax heating system

174. Portable atomizing rod

175. Home health magnet

176. Tepidity Pad

177. Disposable closed body fluid indwelling device (midstream urine)

178. Digital PCR chip

179. Sealing glue

180. Disposable organ bagging

181. Automatic multi-bottle air sampler

182. Microscope oil

183. Constant temperature oscillation incubator

184. Mixed suction head

185. Sperm extraction cup

186. Single-use Pasteur straws

187. Gas collection bag

188. Automatic sample sealing machine

189. Photosensitive blood collection pillow

190. Disposable blood collection towel

191. Liquid chromatography column cleaning solution

192. Microbial mass spectrometry target plate

193. Sheet sealing tape

194. Expiratory collector

195. Three-dimensional micro-carrier

196. Microbial aerosol sampler

China is encouraging China end uses for more domestic products in latest years. Thus, more and more overseas manufacturers are planning localization in China. BradyKnows localization team has extensive experiences in facility establishment, audit, supplier evaluation, manufacturing, registration, and marketing in China. Pls feel free to let us know any questions on China entry via info@bradyknowsmedical.com

By Alliance of Medical Device Distributors

Translated & edited  | Bradyknows