NMPA: Industry Standards Changes in December

NMPA changed status of forty industry standards from “Mandatory” to “Recommended” in December 2019.

Although both mandatory and recommended standards are not legally binding, manufacturers better to comply with them in order to expedite type testing and shorten new or renewal registration time. China Med Device, LLC has test engineers onsite at NMPA testing centers to help you.info@ChinaMedDevice.com.

Generic Guideline

Among those is a generic guideline:

YY / T 0033-2000 Good Manufacturing Practice for Sterile Medical Devices

NMPA takes a specific interest in sterile devices, implants, and IVDs for manufacturing inspection. For our comments on 2019 National Quality Inspection Plan, please click HERE.

China Med Device, LLC has test engineers at NMPA testing centers to help you assess and expedite your type testing needs and shorten your renewal or new approval time. info@ChinaMedDevice.com.

Full List

Below is the full list of standards published in December.

1. YY/T 0292.1-1997 Medical diagnostic X-ray radiation protective equipment. Part 1: Determination of attenuation properties of materials
2. YY / T 0801.1-2010 Terminals for medical gas piping systems Part 1 Terminals for compressed medical gas and vacuum
3. YY / T 0801.2-2010 Terminals for medical gas piping systems Part 2 Terminals for anesthetic gas purification systems
4. YY / T 0078-1992 General technical requirements for tracheal foreign body forceps
5. YY / T 0076-1992 Classification of coatings for metal parts
6. YY / T 1012-2004 Dental handpiece Coupling size
7. YY / T 0314-2007 Single-use human venous blood sample collection container
8. YY / T 0770.1-2009 Filter material for medical infusion and injection equipment Part 1: Medical liquid filter material
9. YY / T 0770.2-2009 Filter material for medical infusion and injection equipment Part 2: Air filter material
10. YY / T 0331-2006 Performance requirements and test methods for absorbent cotton gauze, absorbent cotton viscose blended gauze
11. YY / T 0854.1-2011 Performance requirements for cotton non-woven surgical dressings-Part 1: Non-woven fabrics for dressing production
12. YYY / T 0854.2-2011 Performance requirements for cotton non-woven surgical dressings Part 2: Finished dressings
13. YY / T 0033-2000 Good Manufacturing Practice for Sterile Medical Devices
14. YY / T 91133-1999 Pistol type hand bone drill
15. YY / T 0868-2011 electrodes for nerve and muscle stimulators
16. YY / T 0904-2013 battery-powered bone tissue surgery equipment
17. YY / T 0903-2013 EEG biofeedback instrument
18. YY / T 0902-2013 contact far infrared physiotherapy equipment
19. YY / T 0623-2008 Method for determination of soluble fluorine in dental materials
20. YY / T 0715-2009 Dentistry Silver amalgam capsule
21. YY / T 0769-2009 dental phosphate etching agent
22. YY / T 0067-2007 Microcirculation microscope
23. YY / T 0068.3-2008 Medical endoscopes Rigid endoscopes Part 3: Labels and accompanying materials
24. YY / T 0290.1-2008 Ophthalmic optics Intraocular lens Part 1: Terminology
25. YY / T 0290.4-2008 Ophthalmic optics Intraocular lens Part 4: Labels and information
26. YY / T 0290.6-2009 Ophthalmic optics Intraocular lens Part 6: Shelf life and transport stability
27. YY / T 0677-2008 Liquid nitrogen cryosurgery treatment equipment
28. YY / T 0718-2009 ophthalmic instrument
29. YY / T 0719.1-2009 Ophthalmic optics Contact lens care products Part 1: Terminology
30. YY / T 0719.3-2009 Ophthalmic optics Contact lens care products Part 3: Microbiological requirements and test methods and contact lens care system
31. YY / T 0719.4-2009 Ophthalmic optics Contact lens care products Part 4: Guide to antimicrobial preservative effectiveness test and determination of discard date
32. YY / T 0719.5-2009 Ophthalmic optics Contact lens care products Part 5: Determination of physical compatibility of contact lenses and contact lens care products
33. YY / T 0719.6-2010 Ophthalmic optics Contact lens care products Part 6: Guidelines for determination of expiration date
34. YY / T 0719.7-2011 Ophthalmic optics Contact lens care products Part 7: Test methods for biological evaluation
35. YY / T 0763-2009 medical endoscope lighting optical cable
36. YY / T 0764-2009 Ophthalmic instrument Eye chart projector
37. YY / T 1036-2004 Indentation tonometer
38. YY / T 0755-2009 Anesthesia evaporator Anesthesia filling system
39. YY / T 1040.2-2008 Anesthesia and breathing equipment Conical joints Part 2: Threaded load-bearing joints
40. YY / T 0954-2015 passive surgical implant-type I collagen implant