How to accelerate the registration of imported medical device?

The revised Regulations for the Supervision and Administration of Medical Devices, (Decree No. 650) has implemented on Jun 1^st 2014. Its related administration measures such as Administrative Measures for Medical Device Registration (CDFA No.4) and Administrative Measures for the Registration of In Vitro Diagnostic Reagents (CFDA No.5) have implemented on Oct 1^st2014.
According to those regulations and administration measures, any medical devices required to obtain the Medical Device Registration Certificate prior to inducing into Chinese market.
How to accelerate the registration of imported medical device? CIRS make a summary of registration/record process for applicant to accelerate, as following:

Stage	Registration Step	If Necessary	Announcements
1	The foreign sales license for medical devices in original state or region	Yes	The specifications and models of the product shall be consistent with the foreign sales license of original state or region.
2	Appoint registration agent	Yes	The registration agent shall be representative organization or enterprise legal person in China (government approved).
3	Confirm Chinese classified level	Yes	1. Medical device with drug shall apply for defining the management attribute
			2. Medical device which belongs to the Medical Device Classification Catalogue or has been issued the announcement, can be determined the level directly.
			3. Medical device which is not listed on Chinese market can be registered according to the class III registration regulation or apply to CFDA for category identification
4	Registration inspection	Yes	1. Compiling product technical requirements according to product features, Chinese standard, industrial standard, Chinese pharmacopoeia, and so on.
			2. Compiling instructions and labels according to Administrative Rules for the Instructions and Labels of Medical Devices.
			3. Testing & Inspection Institute shall have medical device inspection qualification approved by CFDA
			4. Please choice the Testing & Inspection Institute with extensive expertise for product.
5	Commission inspection	No	1.The main is Biological evaluation relevant tests
			2. If the product has completed biological evaluation relevant tests and biocompatibility evaluation in GLP laboratory according to ISO standard, the product do not need to do biological evaluation relevant tests.
			3. If the product does not meet the above, its biological evaluation relevant tests shall be taken in GLP laboratory approved CFDA, and completing biological evaluation.
6	Clinical evaluation	Yes	1. If the product belongs to the Catalogue of Medical Devices Exempted from Clinical trials in China, it can exempt from clinical trials in China. However, it shall provide clinical comparing explain according to Technical guiding principle on medical devices clinical evaluation. In case of any discrepancy, please take necessary clinical trial for differences part or submit supporting data to complete clinical evaluation.
			2. If the product does not belong to the Catalogue of Medical Devices Exempted from Clinical trials in China, but the same variety of product has completed clinical trial in China and obtained the clinical data. Submitting clinical evaluation data which is obtained by comparing with the same variety of product according to Technical guiding principle on medical devices clinical evaluation.
			3. If the product does not belong to the Catalogue of Medical Devices Exempted from Clinical trials in China, and cannot obtain the clinical data of the same variety of product. Please take clinical trial in China and submit clinical evaluation data according to Technical guiding principle on medical devices clinical evaluation.
			4. Clinical evaluation data shall include clinical trial data of raw materials
7	Registration approval and acquire the Medical Device Registration Certificate	Yes	1. Registration data involved in the original certificate and copy, the consistency shall be notarized; The authenticity of corporate signature and stamp shall be notarized.
			2. Registration data shall be true and consistencies.
			3. Research data shall be detailed as far as possible, contain design development and validation part of ISO13485
			4. The record of Class I medical device according to CFDA notice No. 26
			5. The application documents of Class II or Class III shall organize according to CFDA notice No. 43 and CFDA notice No. 44.
Remark	1.The Class I medical device shall belongs to the Medical Device of Class I Classification Catalogue issued on Jun 1^st,2014 2.The stages of registration of Class I must be 1-3,5(Commission inspection can be self test, if involve in ) electrical safety and electromagnetic compatibility, the product shall be tested by institute approved CDFA, 6-7.

If the applicant documents are insufficient, the supplementation shall be replenished once and for all within a year after CFDA issue the supplementation notice.
In order to accelerate the registration and reduce the supplementation, applicant shall complete sufficient basic research, and the product shall meet Chinese Standard.

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