From 2021, Shanghai can allow medical device wholesale enterprises "one certificate multi-site"!

Pharmaceutical Network January 4th, December 29th, the Shanghai Municipal Drug Administration issued "on the implementation of medical device wholesale enterprises in some parts of the city" one certificate multi-site" supervision pilot notice, "Shanghai Pharmaceutical Regulatory Commission (2020) No. 237" (hereinafter referred to as "Notice").
"Notice" clearly, in order to improve the relevance and effectiveness of supervision, urge medical device wholesale enterprises to standardize the establishment of cross-regional business premises, further implement the responsibility of regional supervision, after research and decision in Pudong New Area, Hongkou District, Baoshan District, Songjiang District, Jiading District within the five jurisdictions to carry out medical device wholesale enterprises "one certificate multi-site" supervision pilot.
The term "one certificate multi-site" as used in this Notice means that "the same wholesale medical device enterprise, in accordance with the needs of business development, shall, within the scope of the pilot administrative area of the city, add one or more offices across the district on the basis of the original business premises, as a non-independent business premises, and, after approval or filing, shall be listed with the original business premises on the Medical Device Business License or the Second Class Medical Device Business Record Certificate".
" this pilot only applies to business license "residence" and the original business premises and new "business premises" are located in Pudong New Area, Hongkou District, Baoshan District, Songjiang District, Jiading District within the five administrative areas engaged in the wholesale of medical equipment enterprises.
shall not be used for the time being if the mode of operation is wholesale and retail or retail.
pilot period will be effective from 1 January 2021 until 31 December 2021.
The following is the full text of the Notice: "On the implementation of medical device wholesale enterprises in some areas of the city " one certificate multi-site" supervision pilot notice" Pudong New Area, Hongkou District, Baoshan District, Songjiang District, Jiading District Market Supervision Bureau: In order to improve the relevance and effectiveness of supervision, urge medical device wholesale enterprises to standardize cross-regional set up business premises, further implement the responsibility of local supervision, after research decided to carry out in your five jurisdictions "one-site" supervision pilot.
The relevant matters are heeded as follows: First, "one certificate multi-site" content of this notice refers to "the same medical device wholesale enterprise, in accordance with the needs of business development, within the scope of the city's pilot administrative area, on the basis of the original business premises, the establishment of an additional office space across the district, as a non-independent business premises, after approval or filing, with the original business premises listed in the "medical device business license" or "second category of medical device business documents."
" II, the pilot scope, time this pilot only applies to business license "residence" and the original business premises and new "business premises" are located in Pudong New Area, Hongkou District, Baoshan District, Songjiang District, Jiading District within the five administrative areas engaged in the wholesale of medical equipment enterprises.
shall not be used for the time being if the mode of operation is wholesale and retail or retail.
pilot period will be effective from 1 January 2021 until 31 December 2021.
period, the state regulations and regulations make clear, in accordance with its provisions to implement the third, processing conditions, procedures (1) bid conditions.
medical device wholesale enterprises applying for "one certificate, multiple sites" shall comply with the basic conditions stipulated in the Measures for the Supervision and Administration of Medical Device Operations and the Regulations on the Implementation of the Shanghai Medical Device Management Practices.
on the basis of meeting the licensing conditions, the newly added business premises may be located within the administrative area of the place of residence or within the scope of other pilot administrative areas.
(ii) to handle the procedures.
a medical device wholesale enterprise that has been licensed (for the record) within the scope of the pilot area may apply to the original licensing authority for "one certificate multi-site" in accordance with the relevant procedures for changing the business premises.
a new wholesale medical device enterprise that has opened or continued, and at the same time applys for the establishment of a business premises across districts, it shall apply to the District Market Supervision Bureau where the "domicile" is located for a new office or continuation.
(iii) labeling method.
"One certificate multi-site" for licensing (filing) shall be listed in the column "Business premises" of the "Medical Device Business License" or the "Business Premises" of the "Second Class Medical Device Business Record Certificate" in accordance with the Arabic numeral "1,2" and marked with the words "(one certificate multi-site)" in that column.
, work requirements (1) to fully understand the significance of the pilot work, and actively and steadily promote the work.
"One certificate multi-site" supervision pilot, is in accordance with the "medical device operation supervision and management measures", closely combined with the actual situation of the city, the specific matters of medical device business license expansion implementation, it is not only conducive to promoting day-to-day supervision work, but also conducive to further optimize the business environment.
market supervision bureau of the pilot area should attach great importance to, take effective measures, do a good job in policy publicity and interpretation, and steadily and orderly promote the implementation of "one certificate, many sites".
(ii) to implement the pilot supervision responsibilities and establish a collaborative regulatory mechanism.
In accordance with the principle of "who issues the certificate and who supervises", the certification department shall assume the day-to-day supervision responsibilities, and if the market supervision department in the pilot area finds that the enterprises in the non-jurisdiction are suspected of operating illegally, it shall report to the higher authorities for investigation and punishment in accordance with the law after the designated jurisdiction.
The regulatory department of the issued market shall establish various mechanisms such as information sharing, coordinated supervision and strengthening of law enforcement cooperation with the market regulatory authorities where the "one certificate multi-site" cross-regional business premises are located, so as to form a joint management and management force to provide regulatory experience for the next pilot work.
(iii) to timely feedback on the pilot information, do a good job of summary assessment.
the pilot area market supervision bureau should carefully collect the views and suggestions in the pilot process, encounter related problems to contact the municipal drug regulatory bureau in a timely manner, the pilot situation should be timely summary report.
Drug Administration will pay close attention to the progress of the pilot, strengthen policy guidance, organization and coordination, follow up the supervision, summary and evaluation work.
Shanghai Drug Administration on December 25, 2020